Medroxyprogesterone Acetate

Generic Name: Medroxyprogesterone Acetate
Brand Name: PROVEDIC®
Dosage Form: Injection 150mg/1ml
Pharmacological Category: Progestins
Therapeutic Category: Sex Hormones
Pregnancy Category: Category X

Pharmacology

Medroxyprogesterone Acetate Injectable Suspension, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

Pharmacokinetics:

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

Indications:

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

Contraindications:

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

Precautions:

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

Drug Interactions:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Side Effects:

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

Storage:

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

Packing:

• Injection 150mg/1ml: Box of 1 ampoule

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Brand Name: 

PROVEDIC®

Dosage Form: 

Injection 150mg/1ml

Pharmacological Category: 

Progestins

Therapeutic Category: 

Sex Hormones

Pregnancy Category: 

Category X

Medroxyprogesterone Acetate Injectable Suspension, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

Pharmacokinetics: 

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

Indications: 

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

Contraindications: 

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

Precautions: 

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

Drug Interactions: 

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Side Effects: 

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

Storage: 

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

Packing: 

• Injection 150mg/1ml: Box of 1 ampoule

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• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

[view] =>

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

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Injection 150mg/1ml

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Injection 150mg/1ml

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• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

[view] =>

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

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medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

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medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

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• Injection 150mg/1ml: Box of 1 ampoule

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Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.


Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).


Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.


Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

[format] => 1 [safe] =>

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

[view] =>

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

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Progestins

[view] =>

Progestins

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

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.


Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.


Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

[format] => 1 [safe] =>

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

[view] =>

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

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Category X

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Category X

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More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding


Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

[format] => 1 [safe] =>

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

[view] =>

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

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

[view] =>

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

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Sex Hormones

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Sex Hormones

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PROVEDIC®

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PROVEDIC®

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Dosage Form: 

Injection 150mg/1ml

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Progestins

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

Progestins

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

Progestins

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Progestins

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

Progestins

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Sex Hormones

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Sex Hormones

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Sex Hormones

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Sex Hormones

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

Sex Hormones

[#printed] => 1 ) [field_pregnancy_category] => Array ( [#type_name] => product [#context] => full [#field_name] => field_pregnancy_category [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 2 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_pregnancy_category [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => Category X [format] => 1 [safe] =>

Category X

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

Category X

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

Category X

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

Category X

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

Category X

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

Medroxyprogesterone Acetate Injectable Suspension, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

[#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] =>

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.


Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).


Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.


Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

[format] => 1 [safe] =>

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

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

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

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

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

[#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] =>

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

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

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

[#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] => medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain. [format] => 1 [safe] =>

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

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

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

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

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

[#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] =>

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

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

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

[#printed] => 1 ) [field_administration_and_dosage] => Array ( [#type_name] => product [#context] => full [#field_name] => field_administration_and_dosage [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 6 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_administration_and_dosage [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => [format] => [safe] => [#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [#title] => [#description] => [#printed] => 1 ) [#single] => 1 [#attributes] => Array ( ) [#required] => [#parents] => Array ( ) [#tree] => [#context] => full [#page] => 1 [#field_name] => field_administration_and_dosage [#title] => Administration and Dosage [#access] => 1 [#label_display] => above [#teaser] => [#node] => stdClass Object *RECURSION* [#type] => content_field [#printed] => 1 ) [#title] => [#description] => [#printed] => 1 ) [field_contraindications] => Array ( [#type_name] => product [#context] => full [#field_name] => field_contraindications [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 7 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_contraindications [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => • Known or suspected pregnancy or as a diagnostic test for pregnancy. • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease . • Known or suspected malignancy of breast. • Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients. • Significant liver. • Undiagnosed vaginal bleeding . [format] => 1 [safe] =>

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

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

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

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

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

[#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] =>

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

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

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

[#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] =>

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.


Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.


Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

[format] => 1 [safe] =>

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

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

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

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

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

[#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] =>

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

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

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

[#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] => • barbiturates • bosentan • carbamazepine • felbamate • griseofulvin • oxcarbazepine • phenytoin • rifampin • St. John's wort • topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors. Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. [format] => 1 [safe] =>

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

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

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

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

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

[#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] =>

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

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

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

[#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] =>

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding


Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

[format] => 1 [safe] =>

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

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

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

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

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

[#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] =>

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

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

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

[#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] => • Injection 150mg/1ml: Box of 1 ampoule [format] => 1 [safe] =>

• Injection 150mg/1ml: Box of 1 ampoule

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

• Injection 150mg/1ml: Box of 1 ampoule

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

• Injection 150mg/1ml: Box of 1 ampoule

[#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] =>

• Injection 150mg/1ml: Box of 1 ampoule

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

• Injection 150mg/1ml: Box of 1 ampoule

[#printed] => 1 ) [field_references] => Array ( [#type_name] => product [#context] => full [#field_name] => field_references [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 13 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_references [#weight] => 0 [#theme] => text_formatter_default [#item] => Array ( [value] => [format] => [safe] => [#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [#title] => [#description] => [#printed] => 1 ) [#single] => 1 [#attributes] => Array ( ) [#required] => [#parents] => Array ( ) [#tree] => [#context] => full [#page] => 1 [#field_name] => field_references [#title] => References [#access] => 1 [#label_display] => above [#teaser] => [#node] => stdClass Object *RECURSION* [#type] => content_field [#printed] => 1 ) [#title] => [#description] => [#printed] => 1 ) [field_pdf] => Array ( [#type_name] => product [#context] => full [#field_name] => field_pdf [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 14 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_pdf [#weight] => 0 [#theme] => filefield_formatter_default [#item] => Array ( [#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [#title] => [#description] => [#printed] => 1 ) [#single] => 1 [#attributes] => Array ( ) [#required] => [#parents] => Array ( ) [#tree] => [#context] => full [#page] => 1 [#field_name] => field_pdf [#title] => PDF [#access] => 1 [#label_display] => above [#teaser] => [#node] => stdClass Object *RECURSION* [#type] => content_field [#printed] => 1 ) [#title] => [#description] => [#printed] => 1 ) [field_related_products] => Array ( [#type_name] => product [#context] => full [#field_name] => field_related_products [#post_render] => Array ( [0] => content_field_wrapper_post_render ) [#weight] => 15 [field] => Array ( [#description] => [items] => Array ( [0] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_related_products [#weight] => 0 [#theme] => nodereference_formatter_default [#item] => Array ( [nid] => [i18nsync] => 1 [safe] => Array ( ) [#delta] => 0 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [1] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_related_products [#weight] => 1 [#theme] => nodereference_formatter_default [#item] => Array ( [nid] => [i18nsync] => 1 [safe] => Array ( ) [#delta] => 1 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [2] => Array ( [#formatter] => default [#node] => stdClass Object *RECURSION* [#type_name] => product [#field_name] => field_related_products [#weight] => 2 [#theme] => nodereference_formatter_default [#item] => Array ( [nid] => [i18nsync] => 1 [safe] => Array ( ) [#delta] => 2 ) [#title] => [#description] => [#theme_used] => 1 [#printed] => 1 [#type] => [#value] => [#prefix] => [#suffix] => ) [#title] => [#description] => [#printed] => 1 ) [#single] => 1 [#attributes] => Array ( ) [#required] => [#parents] => Array ( ) [#tree] => [#context] => full [#page] => 1 [#field_name] => field_related_products [#title] => Related Products [#access] => 1 [#label_display] => above [#teaser] => [#node] => stdClass Object *RECURSION* [#type] => content_field [#printed] => 1 ) [#title] => [#description] => [#printed] => 1 ) [#title] => [#description] => [#children] =>
Brand Name: 

PROVEDIC®

Dosage Form: 

Injection 150mg/1ml

Pharmacological Category: 

Progestins

Therapeutic Category: 

Sex Hormones

Pregnancy Category: 

Category X

Medroxyprogesterone Acetate Injectable Suspension, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

Pharmacokinetics: 

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL.

Distribution:
Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism:
MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion:
The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

Indications: 

medroxyprogesterone acetate is indicated for the prevention of pregnancy in women of child bearing potential.also is indicated for management of endometriosis-associated pain.

Contraindications: 

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease .
• Known or suspected malignancy of breast.
• Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients.
• Significant liver.
• Undiagnosed vaginal bleeding .

Precautions: 

It is good medical practice for all women to have annual history and physical examinations, including women using medroxyprogesterone acetate. The physical examination, however, may be deferred until after initiation medroxyprogesterone acetate if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention
Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain
Weight gain is a common occurrence in women using medroxyprogesteone acetate. In three large clinical trials using medroxyprogesterone acetate, the mean weight gain was 1.6kg in the first year of use Although there are no data related to weight gain beyond 2 years for medroxyprogesterone acetate. In a clinical study, after five years, 41 women using medroxyprogesterone acetate (150 mg) had a mean weight gain of 5kg, while 114 women using non-hormonal contraception had a mean weight gain of 2.9kg.

Drug Interactions: 

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John's wort
• topiramate

HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors.
Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Side Effects: 

More common:
• Absent, missed, or irregular menstrual periods
• menstrual changes
• stopping of menstrual bleeding

Less common:
• Breast pain
• cramps
• heavy bleeding
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• swelling
• thick, white vaginal discharge with no odor or with a mild odor

Storage: 

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

Packing: 

• Injection 150mg/1ml: Box of 1 ampoule

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button

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