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Depo-subq Provera Generic Name & Formulations
Legal Class
Rx
General Description
Medroxyprogesterone acetate 104mg/0.65mL; SC inj; contains parabens.
Pharmacological Class
Progestin.
See Also
How Supplied
Vials—1, 25; Prefilled syringe (1mL)—1 (w. needles); SubQ (prefilled syringe)—1 (w. needle)
Manufacturer
Depo-subq Provera Indications
Indications
Injectable contraception.
Limitations of Use
Not recommended as a long-term (eg, >2yrs) birth control method unless other options are considered inadequate.
Depo-subq Provera Dosage and Administration
Adult
Inject 104mg SC every 3 months (12 to 14 weeks). Give 1st dose within 5 days of onset of normal menses (see full labeling for postpartum).
Children
Pre-menarche: not applicable.
Depo-subq Provera Contraindications
Contraindications
Active thrombophlebitis. Thromboembolic disorders. Cerebrovascular disease. Breast carcinoma. Significant liver disease. Undiagnosed vaginal bleeding. Pregnancy.
Depo-subq Provera Boxed Warnings
Boxed Warning
Loss of bone mineral density.
Depo-subq Provera Warnings/Precautions
Warnings/Precautions
May lose significant bone mineral density (BMD). Evaluate BMD with long-term use or in adolescents. Risk for osteoporosis (eg, metabolic bone disease, anorexia, family history). Previous or family history of breast cancer (monitor closely). Ectopic pregnancy. History of depression; monitor for mood changes. Diabetes. Monitor conditions aggravated by fluid retention. Do pretreatment physical exam. Discontinue if jaundice or elevated transaminases, visual disturbances, migraine, or thrombotic disorders occur. Nursing mothers.
Depo-subq Provera Pharmacokinetics
See Literature
Depo-subq Provera Interactions
Interactions
May be antagonized by moderate or strong CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, St. John's wort, others); avoid. May reduce bone mass with anticonvulsants, corticosteroids; avoid alcohol, tobacco. May be affected by protease inhibitors, NNRTIs. May affect results of lab tests (eg, coagulation factors, lipids, glucose tolerance, and binding proteins); see full labeling.
Depo-subq Provera Adverse Reactions
Adverse Reactions
Dysfunctional uterine bleeding, headache, increased weight, amenorrhea, inj site reactions, vaginitis, abdominal pain, UTIs, acne; decreased BMD, anaphylaxis.
Depo-subq Provera Clinical Trials
See Literature
Depo-subq Provera Note
Not Applicable
Depo-subq Provera Patient Counseling
See Literature
Depo-subq Provera Generic Name & Formulations
Legal Class
Rx
General Description
Medroxyprogesterone acetate 104mg/0.65mL; SC inj; contains parabens.
Pharmacological Class
Progestin.
See Also
How Supplied
Prefilled syringe—1 (w. needle)
Manufacturer
Depo-subq Provera Indications
Indications
Pain due to endometriosis.
Limitations of Use
Not recommended as a long-term (eg, >2yrs) medical therapy for endometriosis-associated pain unless other options are considered inadequate.
Depo-subq Provera Dosage and Administration
Adult
See full labeling. Inject 104mg SC every 3 months (12 to 14 weeks). Give 1st dose within 5 days of onset of normal menses.
Children
Pre-menarche: not applicable.
Depo-subq Provera Contraindications
Contraindications
Active thrombophlebitis. Thromboembolic disorders. Cerebrovascular disease. Breast carcinoma. Significant liver disease. Undiagnosed vaginal bleeding. Pregnancy.
Depo-subq Provera Boxed Warnings
Boxed Warning
Loss of bone mineral density.
Depo-subq Provera Warnings/Precautions
Warnings/Precautions
May be used as contraceptive; other hormonal contraceptives: not recommended. May lose significant bone mineral density (BMD). Evaluate BMD with long-term use or in adolescents. Risk for osteoporosis (eg, metabolic bone disease, anorexia, family history). Previous or family history of breast cancer (monitor closely). Ectopic pregnancy. History of depression; monitor for mood changes. Diabetes. Monitor conditions aggravated by fluid retention. Do pretreatment physical exam. Discontinue if jaundice or elevated transaminases, visual disturbances, migraine, or thrombotic disorders occur. Nursing mothers.
Depo-subq Provera Pharmacokinetics
See Literature
Depo-subq Provera Interactions
Interactions
May be antagonized by moderate or strong CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, St. John's wort, others); avoid. May reduce bone mass with anticonvulsants, corticosteroids; avoid alcohol, tobacco. May be affected by protease inhibitors, NNRTIs. May affect results of lab tests (eg, coagulation factors, lipids, glucose tolerance, and binding proteins); see full labeling.
Depo-subq Provera Adverse Reactions
Adverse Reactions
Dysfunctional uterine bleeding, headache, increased weight, amenorrhea, inj site reactions, vaginitis, abdominal pain, UTIs, acne; decreased BMD, anaphylaxis.
Depo-subq Provera Clinical Trials
See Literature
Depo-subq Provera Note
Not Applicable
Depo-subq Provera Patient Counseling
See Literature
