Provera


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Provera

 [pro-ver´ah]
trademark for preparations of medroxyprogesterone acetate, a progestational agent.

medroxyprogesterone acetate

Apo-Medroxy (CA), Climanor (UK), Depo-Provera, Depo-SUBQ-Provera 104, Dom-Medroxyprogesterone (CA), Gen-Medroxy (CA), Novo-Medrone (CA), PMS-Medroxyprogesterone (CA), Provera, Ratio-MPA

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.

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.

Provera

(prō-vĕr′ə)
A trademark for a preparation of medroxyprogesterone acetate.

Provera

A brand name for the PROGESTOGEN drug METHYLPROGESTERONE.
References in periodicals archive ?
For additional information on reducing the use of Provera, see my July 2014 editorial, "Hormone therapy for menopausal vasomotor symptoms," at obgmanagement.com.
"I don't support restrictions in this area (the settlements) because they can harm factories where Israeli and Palestinian employees work together, have similar salaries, make the same sacrifices and have the same possibilities for attaining a good standard of living in dignity," The Jerusalem Post quoted Provera saying during his visit to Israel.
Tronchetti Provera said: "Does Tevez still interest us?
Provera noted that natural rubber prices hit an all-time high this month and his company is making concerted efforts to develop tires that use less natural rubber in an effort to offset the rising raw material costs.
The Controversy: Though Depo- Provera made its way into the country fifteen years ago and has been available in the private sector, the proposal to introduce it on a large scale in public sector was withdrawn at that time due to the protests of women's groups.
During these separate meetings, Bagis, Provera and Rujiten discussed Turkey's EU negotiations and the Progress Report published by the EU Commission last week.
Sources say Dr Farshchian began prescribing Depo Provera after he became concerned at Jacko's attitude to young boys at his infamous Neverland sleepovers.
Q I RECENTLY went on to depo provera, the birth control injection, as I kept forgetting to take my pill.
Adtech Provera SpA in Rovato, Italy, held an open house in April to demonstrate a 5-meter-wide cast stretch-film line with four extruders (180-, 160-, and two 120-mm diam.) for up to 7-layer cast film.
This study among 6,109 HIV-negative women recruited from family planning clinics who were using either Depo Provera or combined oral contraception in Uganda and Zimbabwe tested the women quarterly for HIV over 15-24 months.
The correct method of HT, in my opinion, is the use of Premarin from days 1 to 25 of the month, combined with Provera from days 13 to 25 of the month.