Fentanyle Citrate

Generic Name: Fentanyle Citrate
Brand Name: -
Dosage Form: Injection 0/5 mg/10ml
Pharmacological Category: Opioid Analgesic
Therapeutic Category: Opioid analgesic, anesthesia adjunct
Pregnancy Category: category C

Pharmacology

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Pharmacokinetics:

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

Indications:

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

Contraindications:

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

Precautions:

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

Drug Interactions:

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

Side Effects:

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

Storage:

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

Packing:

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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Image: 
Brand Name: 

-

Dosage Form: 

Injection 0/5 mg/10ml

Pharmacological Category: 

Opioid Analgesic

Therapeutic Category: 

Opioid analgesic, anesthesia adjunct

Pregnancy Category: 

category C

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Pharmacokinetics: 

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

Indications: 

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

Contraindications: 

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

Precautions: 

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

Drug Interactions: 

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

Side Effects: 

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

Storage: 

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

Packing: 

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

PDF: 
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• Alcohol intolerance
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• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

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• Children younger than age 18 who weigh less than 50 kg (110 lb)

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Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
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Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

[view] =>

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

[view] =>

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

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Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

[view] =>

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

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EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

[view] =>

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

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• Protect from light and freezing

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category C

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

category C

[#printed] => 1 ) [body] => Array ( [#weight] => 3 [#value] =>

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

[#title] => [#description] => [#printed] => 1 ) [field_pharmacokinetics] => Array ( [#type_name] => product [#context] => full [#field_name] => field_pharmacokinetics [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 4 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_pharmacokinetics [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => Distribution Highly lipophilic. It is 80% to 85% protein bound Metabolism Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4. Elimination IV Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min Onset Immediately (IV); 7 to 8 min (IM). Duration 30 to 60 min (IV); 1 to 2 h (IM). [format] => 1 [safe] =>

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

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

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

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

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

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

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

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

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

[#printed] => 1 ) [field_indications] => Array ( [#type_name] => product [#context] => full [#field_name] => field_indications [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 5 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_indications [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => • Breakthrough pain in opioid-tolerant patients with cancer • Management of chronic pain in patients requiring opioid analgesics • Short-term analgesia during anesthesia and immediate preoperative and postoperative periods • General anesthesia (with oxygen only) • Adjunct to regional anesthesia [format] => 1 [safe] =>

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

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• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

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

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

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

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

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

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

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

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

[#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] => Use cautiously in: • diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment • alcoholism or drug abuse • elderly patients • pregnant patients • children younger than age 2 (safety not established) [format] => 1 [safe] =>

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

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

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

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

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

[#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] =>

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

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

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

[#printed] => 1 ) [field_drug_interactions] => Array ( [#type_name] => product [#context] => full [#field_name] => field_drug_interactions [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 9 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_drug_interactions [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => Barbiturate anesthetics: decreased effects of both drugs Buprenorphine, dezocine, nalbuphine: decreased analgesic effect CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension MAO inhibitors: severe, unpredictable reactions Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients [format] => 1 [safe] =>

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

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

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

[#printed] => 1 ) [field_side_effects] => Array ( [#type_name] => product [#context] => full [#field_name] => field_side_effects [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 10 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_side_effects [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock EENT: blurred vision, diplopia, laryngospasm GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria Musculoskeletal: skeletal and thoracic muscle rigidity Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site [format] => 1 [safe] =>

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

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

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

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

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

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

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

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

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

[#printed] => 1 ) [field_storage] => Array ( [#type_name] => product [#context] => full [#field_name] => field_storage [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 11 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_storage [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => • Store below 30 C° • Protect from light and freezing [format] => 1 [safe] =>

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

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

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

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

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

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

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

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

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

[#printed] => 1 ) [field_packing] => Array ( [#type_name] => product [#context] => full [#field_name] => field_packing [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 12 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_packing [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box [format] => 1 [safe] =>

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

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PDF: 
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Image: 
Brand Name: 

-

Dosage Form: 

Injection 0/5 mg/10ml

Pharmacological Category: 

Opioid Analgesic

Therapeutic Category: 

Opioid analgesic, anesthesia adjunct

Pregnancy Category: 

category C

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Pharmacokinetics: 

Distribution
Highly lipophilic. It is 80% to 85% protein bound
Metabolism
Metabolized in the liver and intestinal mucosa to the inactive metabolite norfentanyl by CYP3A4.
Elimination
IV
Approximately 75% is released in the urine, mostly as metabolites, with less than 10% representing the unchanged drug; approximately 9% is released in the feces, primarily as metabolites. Terminal elimination half-life is 219 min
Onset
Immediately (IV); 7 to 8 min (IM).
Duration
30 to 60 min (IV); 1 to 2 h (IM).

Indications: 

• Breakthrough pain in opioid-tolerant patients with cancer
• Management of chronic pain in patients requiring opioid analgesics
• Short-term analgesia during anesthesia and immediate preoperative and postoperative periods
• General anesthesia (with oxygen only)
• Adjunct to regional anesthesia

Contraindications: 

• Hypersensitivity to drug or transdermal adhesive
• Alcohol intolerance
• Acute bronchial asthma
• Pregnancy (transdermal system)
• Breastfeeding
• Children younger than age 18 who weigh less than 50 kg (110 lb)

Precautions: 

Use cautiously in:
• diabetes mellitus, severe or chronic pulmonary or hepatic disease, cardiovascular disease, CNS tumors, adrenal insufficiency, hypothyroidism, renal impairment
• alcoholism or drug abuse
• elderly patients
• pregnant patients
• children younger than age 2 (safety not established)

Drug Interactions: 

Barbiturate anesthetics: decreased effects of both drugs
Buprenorphine, dezocine, nalbuphine: decreased analgesic effect
CNS depressants (antidepressants, other opioid analgesics, sedating antihistamines, sedative-hypnotics, skeletal muscle relaxants): profound sedation, hypoventilation, and hypotension
Erythromycin, ketoconazole, some protease inhibitors: decreased metabolism and increased effects of fentanyl, possibly leading to profound sedation, hypoventilation, and hypotension
MAO inhibitors: severe, unpredictable reactions
Opioid antagonists, partial-antagonist opioid analgesics: withdrawal in physically dependent patients

Side Effects: 

CNS: headache, dizziness, vertigo, floating feeling, lethargy, confusion, light-headedness, nervousness, hallucinations, delirium, insomnia, anxiety, fear, mood changes, tremor, sedation, coma, seizures
CV: palpitations, hypotension, hypertension, tachycardia, bradycardia, arrhythmias, circulatory depression, cardiac arrest, shock
EENT: blurred vision, diplopia, laryngospasm
GI: nausea, vomiting, constipation, biliary tract spasm, dry mouth, anorexia
GU: urinary retention or hesitancy, ureteral or vesical sphincter spasm, decreased libido, erectile dysfunction, oliguria
Musculoskeletal: skeletal and thoracic muscle rigidity
Respiratory: slow and shallow respirations, suppressed cough reflex, apnea, bronchospasm
Skin: local skin irritation (with transdermal system), rash, urticaria, pruritus, diaphoresis, flushing, erythema, cold sensitivity
Other: physical or psychological drug dependence, drug tolerance, pain or phlebitis at injection site

Storage: 

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

Packing: 

Fentanyl citrate injection 0.5 mg/10ml: 5 ampoules/box

PDF: 
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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