Provera

Pro·ver·a (pr-vr)

A trademark for a preparation of medroxyprogesterone acetate.

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Provera,

trademark for a progestin (medroxyprogesterone acetate).

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medroxyprogesterone acetate Warning - Hazardous drug!

Alti-MPA (CA), Climanor (UK), Depo-SUBQ-Provera 104, Depo-Provera, Gen-Medroxy (CA), Novo-Medrone (CA), Provera

Pharmacologic class: Hormone

Therapeutic class: Progestin

Pregnancy risk category X

FDA Boxed Warning

• Injection form may cause significant bone density loss. Loss increases with duration of use and may not be completely reversible. It's 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.

Action

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

Availability

Suspension for depot injection: 150 mg/ml, 400 mg/ml

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)

➣ To prevent pregnancy

Adults: 150 mg (Depo-Provera) deep I.M. injection q 13 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.)

Route	Onset	Peak	Duration
P.O.	Unknown	Unknown	Unknown
I.M.	Wks-1 mo	1 mo	Unknown

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, cholasma, 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.