DEPO-PROVERA CI Rx
Generic Name and Formulations:
Medroxyprogesterone acetate 150mg/mL; IM inj.
Indications for DEPO-PROVERA CI:
Give by deep IM inj in the gluteal or deltoid muscle; rotate inj sites. 150mg every 3 months. Give 1st dose within 5 days of onset of normal menses (see full labeling for postpartum). Do not use for >2 years unless other methods are inadequate.
Pre-menarche: not applicable.
Active thrombophlebitis. Thromboembolic disorders. Cerebrovascular disease. Breast carcinoma. Significant liver disease. Undiagnosed vaginal bleeding. Pregnancy.
Risk of bone mineral density (BMD) loss. Evaluate BMD with long-term use or in adolescents. Risk of osteoporosis (eg, metabolic bone disease, anorexia, family history). Family history of breast cancer or who have breast nodules (monitor closely). History of depression; monitor and do not re-administer if 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. Discontinue if jaundice or liver dysfunction, visual disturbances, migraine, or thrombotic disorders occur. Nursing mothers.
May be antagonized by aminoglutethimide, CYP3A4 inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate). 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.
Menstrual irregularities (eg, bleeding, amenorrhea, spotting), abdominal pain/discomfort, weight gain, dizziness, headache, nervousness, decreased libido; decreased BMD, ectopic pregnancy, acne, inj site reactions (eg, pain/tenderness, persistent atrophy/indentation/dimpling, nodule/lump).
Vials—1, 25; Prefilled syringes (1mL)—1 (w. needles); SubQ (prefilled syringe)—1 (w. needles)
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