Co-Trimoxazole

Generic Name: Co-Trimoxazole
Brand Name: COTRIM®
Dosage Form: Injection 480 mg/5ml
Pharmacological Category: Sulfonamides
Therapeutic Category: Antibiotic
Pregnancy Category: Category C

Pharmacology

Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the N4-acetyl-, N4-hydroxy-, 5-methylhydroxy-, N4-acetyl- 5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of N4-hydroxy metabolite is mediated via CYP2C9.

Trimethoprim is metabolized in vitro to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives.

The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.

In vitro studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein.

Pharmacokinetics:

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

Indications:

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

Contraindications:

• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

Precautions:

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

Drug Interactions:

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

Side Effects:

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

Storage:

• Store below 30 C°
• Protect from light and freezing

Packing:

• Injection 480 mg/5ml: Box of 5 ampoules

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Image: 
Brand Name: 

COTRIM®

Dosage Form: 

Injection 480 mg/5ml

Pharmacological Category: 

Sulfonamides

Therapeutic Category: 

Antibiotic

Pregnancy Category: 

Category C

Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the N4-acetyl-, N4-hydroxy-, 5-methylhydroxy-, N4-acetyl- 5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of N4-hydroxy metabolite is mediated via CYP2C9.

Trimethoprim is metabolized in vitro to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives.

The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.

In vitro studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein.

Pharmacokinetics: 

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

Indications: 

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

Contraindications: 

• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

Precautions: 

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

Drug Interactions: 

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

Side Effects: 

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

Storage: 

• Store below 30 C°
• Protect from light and freezing

Packing: 

• Injection 480 mg/5ml: Box of 5 ampoules

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COTRIM®

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COTRIM®

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• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

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• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

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Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations

Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

[format] => 1 [safe] =>

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

[view] =>

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

) ) [field_indications] => Array ( [0] => Array ( [value] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.


Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.


Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.


Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.


Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.


Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

[format] => 1 [safe] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

[view] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

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• Injection 480 mg/5ml: Box of 5 ampoules

[view] =>

• Injection 480 mg/5ml: Box of 5 ampoules

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Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.


Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.


Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.


Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

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Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

[view] =>

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

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Sulfonamides

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Sulfonamides

) ) [field_precautions] => Array ( [0] => Array ( [value] => Patients with Folate Deficiency or G6PD Deficiency Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related. Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition). Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients. Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment. A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction. Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and [format] => 1 [safe] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

[view] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

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Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.
 
Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.
 
Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.
 
Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.
 
Metabolic and Nutritional: Hyperkalemia, hyponatremia 
 
Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.
 
Psychiatric: Hallucinations, depression, apathy, nervousness.
 
Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
 
Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.
 
Respiratory: Cough, shortness of breath and pulmonary infiltrates.
 
Miscellaneous: Weakness, fatigue, insomnia.
 
[format] => 1 [safe] =>

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

[view] =>

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

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Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the N4-acetyl-, N4-hydroxy-, 5-methylhydroxy-, N4-acetyl- 5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of N4-hydroxy metabolite is mediated via CYP2C9.

Trimethoprim is metabolized in vitro to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives.

The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.

In vitro studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein.

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Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.


Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.


Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.


Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

[format] => 1 [safe] =>

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

[#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => [#children] =>

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

) [#title] => [#description] => [#children] =>

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

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Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Pharmacokinetics: 

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

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Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.


Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.


Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.


Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.


Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.


Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

[format] => 1 [safe] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

[#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => [#children] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

) [#title] => [#description] => [#children] =>

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

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Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Indications: 

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

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• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

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• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

) [#title] => [#description] => [#children] =>

• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

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• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Contraindications: 

• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

[#printed] => 1 ) [field_precautions] => Array ( [#type_name] => product [#context] => full [#field_name] => field_precautions [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 8 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_precautions [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => Patients with Folate Deficiency or G6PD Deficiency Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related. Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition). Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients. Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment. A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction. Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and [format] => 1 [safe] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

[#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => [#children] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

) [#title] => [#description] => [#children] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

[#printed] => 1 ) [#single] => 1 [#attributes] => Array ( ) [#required] => [#parents] => Array ( ) [#tree] => [#context] => full [#page] => 1 [#field_name] => field_precautions [#title] => Precautions [#access] => 1 [#label_display] => above [#teaser] => [#node] => stdClass Object *RECURSION* [#type] => content_field [#children] =>

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Precautions: 

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

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Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations

Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

[format] => 1 [safe] =>

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

[#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => [#children] =>

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

) [#title] => [#description] => [#children] =>

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

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Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Drug Interactions: 

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

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Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.
 
Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.
 
Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.
 
Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.
 
Metabolic and Nutritional: Hyperkalemia, hyponatremia 
 
Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.
 
Psychiatric: Hallucinations, depression, apathy, nervousness.
 
Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
 
Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.
 
Respiratory: Cough, shortness of breath and pulmonary infiltrates.
 
Miscellaneous: Weakness, fatigue, insomnia.
 
[format] => 1 [safe] =>

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

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Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

) [#title] => [#description] => [#children] =>

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

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Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

[#printed] => 1 ) [#title] => [#description] => [#children] =>
Side Effects: 

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

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• Store below 30 C°
• Protect from light and freezing

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• Store below 30 C°
• Protect from light and freezing

) [#title] => [#description] => [#children] =>

• Store below 30 C°
• Protect from light and freezing

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• Store below 30 C°
• Protect from light and freezing

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Storage: 

• Store below 30 C°
• Protect from light and freezing

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• Injection 480 mg/5ml: Box of 5 ampoules

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• Injection 480 mg/5ml: Box of 5 ampoules

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• Injection 480 mg/5ml: Box of 5 ampoules

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• Injection 480 mg/5ml: Box of 5 ampoules

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Packing: 

• Injection 480 mg/5ml: Box of 5 ampoules

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Image: 
Brand Name: 

COTRIM®

Dosage Form: 

Injection 480 mg/5ml

Pharmacological Category: 

Sulfonamides

Therapeutic Category: 

Antibiotic

Pregnancy Category: 

Category C

Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the N4-acetyl-, N4-hydroxy-, 5-methylhydroxy-, N4-acetyl- 5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of N4-hydroxy metabolite is mediated via CYP2C9.

Trimethoprim is metabolized in vitro to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives.

The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.

In vitro studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein.

Pharmacokinetics: 

Co-trimoxazole contains a 1:5 ratio of trimethoprim to sulfamethoxazole, but the trimethoprim: sulfamethoxazole ratio in serum after administration of the fixed-combination preparation is about 1:20 at steady-state.

Distribution
Widely distributed into body tissues and fluids, including sputum, aqueous humor, middle ear fluid, bronchial secretions, prostatic fluid, vaginal fluid, and bile.
In patients with uninflamed meninges, trimethoprim and sulfamethoxazole concentrations in CSF are about 50 and 40%, respectively, of concurrent serum concentrations.
Both sulfamethoxazole and trimethoprim readily cross the placenta and are distributed into milk.

Plasma Protein Binding
Sulfamethoxazole is approximately 70% and trimethoprim is approximately 44% bound to plasma proteins. Presence of sulfamethoxazole decreases protein binding of trimethoprim.

Elimination
Both sulfamethoxazole and trimethoprim are metabolized in the liver.
Both sulfamethoxazole and trimethoprim are rapidly excreted in urine by glomerular filtration and active tubular secretion. In adults with normal renal function, approximately 45–85% of a sulfamethoxazole dose and 50–67% of a trimethoprim dose are excreted in urine.
Only small amounts of trimethoprim are excreted in feces via biliary elimination.
Serum half-lives of sulfamethoxazole and trimethoprim are approximately 10–13 and 8–11 hours, respectively, in adults with normal renal function.

Indications: 

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of Co-Trimoxazole in pediatric patients under two years of age. Co-Trimoxazole is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that Co-Trimoxazole could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

Contraindications: 

• Known hypersensitivity to sulfonamides or trimethoprim.
• Documented megaloblastic anemia due to folate deficiency.
• Children <2 months of age, pregnant women at term, and nursing women.

Precautions: 

Patients with Folate Deficiency or G6PD Deficiency
Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.
Use with caution in patient with possible folate deficiency (e.g., geriatric patients, chronic alcoholics, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients with malnutrition).

Patients with Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia
HIV-infected patients with Pneumocystis jiroveci pneumonia may have an increased incidence of adverse effects during co-trimoxazole therapy (particularly rash, fever, leukopenia, increased liver enzymes) compared with HIV-seronegative patients.The incidence of hyperkalemia and hyponatremia also may be increased in HIV-infected patients.
Adverse effects generally are less severe in those receiving co-trimoxazole for prophylaxis rather than treatment.
A history of mild intolerance to co-trimoxazole in HIV-infected patients does not appear to predict intolerance to subsequent use of the drug for secondary prophylaxis. However, use of the drug should be reevaluated in patients who develop rash or any sign of adverse reaction.
Concomitant use of leucovorin and co-trimoxazole for acute treatment of P. jiroveci pneumonia in HIV-infected patients has been associated with increased rates of treatment failure and

Drug Interactions: 

Amantadine

Toxic delirium reported in an individual who received amantadine and co-trimoxazole concomitantly

Antidepressants, tricyclics

Possible decreased efficacy of the tricyclic antidepressant

Cyclosporine

Reversible nephrotoxicity reported in renal transplant recipients receiving cyclosporine and co-trimoxazole concomitantly

Digoxin

Possible increased digoxin concentrations, especially in geriatric patients

Diuretics

Possible increased incidence of thrombocytopenia and purpura if certain diuretics (principally thiazides) are used concomitantly, especially in geriatric patients

Hypoglycemic agents, oral

Possible potentiation of hypoglycemic effects

Indomethacin

Possible increased sulfamethoxazole concentrations

Methotrexate

Co-trimoxazole can displace methotrexate from plasma protein-binding sites resulting in increased free methotrexate concentrations
Possible interference with serum methotrexate assays if competitive protein binding technique is used with a bacterial dihydrofolate reductase as the binding protein; interference does not occur if methotrexate is measured using radioimmunoassay

Phenytoin

Co-trimoxazole may inhibit metabolism and increase half-life of phenytoin

Pyrimethamine

Megaloblastic anemia reported when co-trimoxazole used concomitantly with pyrimethamine dosages >25 mg weekly (for malaria prophylaxis)

Warfarin

Possible inhibition of warfarin clearance and prolonged PT

 

Side Effects: 

Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

 

Allergic Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

 

Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

 

Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.

 

Metabolic and Nutritional: Hyperkalemia, hyponatremia 

 

Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

 

Psychiatric: Hallucinations, depression, apathy, nervousness.

 

Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.

 

Musculoskeletal: Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with Co-Trimoxazole, mainly in AIDS patients.

 

Respiratory: Cough, shortness of breath and pulmonary infiltrates.

 

Miscellaneous: Weakness, fatigue, insomnia.

 

Storage: 

• Store below 30 C°
• Protect from light and freezing

Packing: 

• Injection 480 mg/5ml: Box of 5 ampoules

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CONTACT US:

Head Office:
Address: No.1, Beastoon Ave., Dr. Fatemi Sq., Tehran1431663135 Iran
Tel: (+98 21)-889 65323
Fax: (+98 21)-889 57056
Factory:
Address: Caspian tamin Pharmaceutical Co., Entrance 1, Rasht Industrial Zone, Rasht, Guilan, Iran
Tel: (+98 131) 338-2511- 8
Fax: (+98 131) 338 – 2517