Provera

Action

Inhibits pituitary gonadotropin secretion, preventing follicular maturation, ovulation, and pregnancy

Availability

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.

Off-label uses

• Advanced breast cancer

Contraindications

• 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

Precautions

Use cautiously in:

• seizure disorder, renal or cardiovascular disease, asthma, diabetes mellitus, depression, migraine

• history of hepatic disease.

Administration

• 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.)

Adverse reactions

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

Hepatic: jaundice

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

Interactions

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

Patient monitoring

• 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.

Patient teaching

• 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.