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Depo-provera Generic Name & Formulations
Legal Class
Rx
General Description
Medroxyprogesterone acetate 400mg/mL; susp for IM inj.
Pharmacological Class
Progestin.
How Supplied
Vials (2.5mL)—1
Manufacturer
Depo-provera Indications
Indications
As adjunctive and palliative treatment of inoperable, recurrent, and metastatic renal carcinoma.
Depo-provera Dosage and Administration
Adult
Initially 400–1000mg IM every week. If improvement noted and disease stabilized within a few weeks or months, may be possible to maintain at 400mg per month.
Children
Not established.
Depo-provera Contraindications
Contraindications
Active thrombophlebitis. Thromboembolic disorders. Cerebrovascular disease.
Depo-provera Boxed Warnings
Not Applicable
Depo-provera Warnings/Precautions
Warnings/Precautions
Risk of bone mineral density (BMD) loss. Evaluate BMD with long-term use or in adolescents. Previous or family history of breast cancer (monitor closely). History of depression; monitor and discontinue if serious depression recurs. Diabetes. Conditions aggravated by fluid retention (eg, migraine, epilepsy, asthma). Cardiac or renal dysfunction. Pretreatment physical exam should include Pap smear and lab tests. May mask onset of climacteric. Monitor hepatic function periodically; temporarily interrupt if hepatic dysfunction develops. Discontinue if jaundice or liver dysfunction, visual disturbances, migraine, or thrombotic disorders occur. Pregnancy. Nursing mothers.
Depo-provera Pharmacokinetics
See Literature
Depo-provera Interactions
Interactions
May be antagonized by aminoglutethimide. Avoid concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort). May affect results of lab tests (eg, coagulation factors, lipids, glucose tolerance, and binding proteins); see full labeling.
Depo-provera Adverse Reactions
Adverse Reactions
Menstrual irregularities (eg, bleeding, amenorrhea, spotting), nausea, edema/fluid retention, facial swelling, weight gain, dizziness, headache, nervousness, corticoid-like effects, hypersensitivity; decreased BMD, acne, inj site reactions (eg, pain/tenderness, persistent atrophy/indentation/dimpling, nodule/lump).
Depo-provera Clinical Trials
See Literature
Depo-provera Note
Not Applicable
Depo-provera Patient Counseling
See Literature
Depo-provera Generic Name & Formulations
Legal Class
Rx
General Description
Medroxyprogesterone acetate 400mg/mL; susp for IM inj.
Pharmacological Class
Progestin.
How Supplied
Vials (2.5mL)—1
Manufacturer
Depo-provera Indications
Indications
As adjunctive and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma.
Depo-provera Dosage and Administration
Adult
Initially 400–1000mg IM every week. If improvement noted and disease stabilized within a few weeks or months, may be possible to maintain at 400mg per month.
Children
Not established.
Depo-provera Contraindications
Contraindications
Active thrombophlebitis. Thromboembolic disorders. Cerebrovascular disease.
Depo-provera Boxed Warnings
Not Applicable
Depo-provera Warnings/Precautions
Warnings/Precautions
Risk of bone mineral density (BMD) loss. Evaluate BMD with long-term use or in adolescents. Previous or family history of breast cancer (monitor closely). History of depression; monitor and discontinue if serious depression recurs. Diabetes. Conditions aggravated by fluid retention (eg, migraine, epilepsy, asthma). Cardiac or renal dysfunction. Pretreatment physical exam should include Pap smear and lab tests. May mask onset of climacteric. Monitor hepatic function periodically; temporarily interrupt if hepatic dysfunction develops. Discontinue if jaundice or liver dysfunction, visual disturbances, migraine, or thrombotic disorders occur. Pregnancy. Nursing mothers.
Depo-provera Pharmacokinetics
See Literature
Depo-provera Interactions
Interactions
May be antagonized by aminoglutethimide. Avoid concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort). May affect results of lab tests (eg, coagulation factors, lipids, glucose tolerance, and binding proteins); see full labeling.
Depo-provera Adverse Reactions
Adverse Reactions
Menstrual irregularities (eg, bleeding, amenorrhea, spotting), nausea, edema/fluid retention, facial swelling, weight gain, dizziness, headache, nervousness, corticoid-like effects, hypersensitivity; decreased BMD, acne, inj site reactions (eg, pain/tenderness, persistent atrophy/indentation/dimpling, nodule/lump).
Depo-provera Clinical Trials
See Literature
Depo-provera Note
Not Applicable
Depo-provera Patient Counseling
See Literature
