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Pharmacologic class: Hormone
Therapeutic class: Progestin
Pregnancy risk category X
FDA Box Warning
• Injection form may cause significant bone density loss. Loss increases with duration of use and may not be completely reversible. It is unknown if use during adolescence or early adulthood reduces peak bone mass and increases risk for osteoporotic fracture later in life.
• Injection form should be used as long-term contraceptive (more than 2 years) only if other contraceptive methods are inadequate.
Inhibits pituitary gonadotropin secretion, preventing follicular maturation, ovulation, and pregnancy
Suspension for depot injection: 150 mg/ml, 400 mg/ml
Suspension for depot subcutaneous injection: 104 mg/0.65 ml in prefilled single-use syringes
Tablets: 2.5 mg, 5 mg, 10 mg
Indications and dosages
➣ Secondary amenorrhea
Adults: 5 to 10 mg/day P.O. for 5 to 10 days, starting at any time during menstrual cycle
➣ Dysfunctional uterine bleeding; menses induction
Adults: 5 to 10 mg/day P.O. for 5 to 10 days, starting on day 16 or 21 of menstrual cycle
➣ To prevent estrogen-related endometrial changes in postmenopausal women
Adults: 2.5 to 5 mg/day P.O. given with 0.625 mg conjugated estrogens P.O. (monophasic regimen); or 5 mg/day P.O. on days 15 to 28 of cycle, given with 0.625 mg conjugated estrogens P.O. daily throughout cycle (biphasic regimen)
➣ Management of endometriosis-associated pain
Adults: 104 mg (Depot-subcutaneous-Provera) in anterior thigh or abdomen q 12 to 14 weeks
➣ To prevent pregnancy
Adults: 150 mg (Depo-Provera) deep I.M. injection q 13 weeks or 104 mg (Depot-subcutaneous-Provera) in anterior thigh or abdomen q 12 to 14 weeks. Give first injection during first 5 days of normal menstrual period or first 5 postpartal days if patient isn't breastfeeding, or during sixth postpartal week if patient is breastfeeding exclusively.
➣ Renal or endometrial cancer
Adults: 400 to 1,000 mg I.M.; may repeat weekly. If improvement occurs, decrease to 400 mg q month.
• Advanced breast cancer
• Hypersensitivity to drug or its components
• Cerebrovascular or thromboembolic disease
• Hepatic dysfunction or disease
• Breast or genital cancer
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
Use cautiously in:
• seizure disorder, renal or cardiovascular disease, asthma, diabetes mellitus, depression, migraine
• history of hepatic disease.
• Before starting therapy, obtain thorough history and physical examination, with emphasis on breast and pelvic organs. Also obtain Pap smear, and repeat annually during therapy.
• With contraceptive use, rule out pregnancy before first dose and when more than 14 weeks have passed since previous dose.
• For I.M. injection, inject deep into gluteal, deltoid, or anterior thigh muscle. Rotate injection sites.
• Be aware that when drug is used to prevent estrogen-related endometrial changes in postmenopausal women, lowest dosage should be used for shortest time, because treatment exceeding 1 year correlates with cancer. (Some combination products have 0.3 mg estrogen/1.5 mg progesterone or 0.45 mg estrogen/1.5 mg progesterone.)
CNS: insomnia, migraine, nervousness, drowsiness, dizziness, fatigue, depression, mood changes
CV: thrombophlebitis, thromboembolism
EENT: diplopia, proptosis, retinal vascular lesions, papilledema
GI: abdominal pain, bloating
GU: amenorrhea, leukorrhea, spotting, cervical secretions, galactorrhea, breast tenderness and secretion, cervical erosions, pelvic pain, infertility
Metabolic: fluid retention, hyperglycemia
Musculoskeletal: leg cramps, back pain
Respiratory: pulmonary embolism
Skin: pruritus, urticaria, rash, acne, alopecia, hirsutism, chloasma, melasma, sterile abscesses, induration at I.M. site
Other: weight and appetite changes, edema, angioedema, allergic reactions including anaphylaxis
Drug-drug. Bromocriptine: decreased bromocriptine efficacy
Carbamazepine, phenobarbital, phenytoin, rifampin: decreased contraceptive efficacy
Drug-diagnostic tests. Alkaline phosphatase, low-density lipoproteins: increased levels
High-density lipoproteins, pregnanediol excretion: decreased levels
Thyroid hormone assays: altered results
Drug-behaviors. Alcohol use: additive CNS depression
• Monitor patient for fluid retention and for signs and symptoms of thrombophlebitis, including pain, swelling, and redness of lower legs.
☞ Assess for visual disturbances and headache. If ocular exam shows papilledema or retinal vascular lesions, drug should be discontinued.
• Evaluate liver function tests.
☞ Watch for abdominal pain, fever, malaise, jaundice, darkened urine, and clay-colored stools.
• Advise patient that drug may cause nausea, vomiting, headache, abdominal pain, painful breast swelling, and abnormal bleeding pattern. Instruct her to report these effects if pronounced.
☞ Tell patient to promptly report bloating, swelling, appetite loss, rash, yellowed skin, mood changes or depression, nervousness, dizziness, chest pain, shortness of breath, visual disturbances, or severe headache.
• Teach patient how to perform breast self-exams.
• Tell patient she must undergo yearly physical examinations with Pap smear.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.