Provera

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Medroxyprogesterone is usually given for only a few days in a row each month. You may need to start taking the medication on a certain day of your menstrual cycle, depending on why you are taking medroxyprogesterone. Follow your doctor's instructions.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using medroxyprogesterone.

This medicine can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking medroxyprogesterone.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Pharmacia and Upjohn Company

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Provera, there are no specific foods that you must exclude from your diet when receiving this medication.

Take Provera exactly as prescribed.

Provera comes as a tablet to be taken by mouth, usually once daily. It is prescribed to be taken for 5 to 10 days in a row per month (cycle dosing). 

Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. The lowest effective dose of Provera has not been determined. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with Provera. 

If you miss an oral dose, take it as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for a missed one.

If you take too much Provera, call your healthcare provider or local Poison Control Center right away.

Avoid smoking while you are taking this medicine. Smoking greatly increases your risk of blood clots.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

In the U.S.

• Aygestin
• Camila
• Errin
• Jolivette
• Lyza
• My Way
• Next Choice
• Nora-BE
• Nor-QD
• Ovrette
• Plan B
• Plan B One-Step
• Provera

In Canada

• Option 2

Available Dosage Forms:

• Tablet

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take tablet with or without food. Take with food if it causes an upset stomach.
• Take Provera at the same time of day.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Very bad dizziness or passing out.
• Bulging eyes.
• Sudden change or loss of eyesight.
• Change in how contact lenses feel in the eyes.
• A lump in the breast, breast soreness, or nipple discharge.
• Breast pain.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Low mood (depression).
• Mood changes.
• Memory problems or loss.
• Swelling in hands or feet.
• Seizures.
• Change in sex ability.

Provera® tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is:

Each Provera tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, and talc. The 2.5 mg tablet contains FD&C Yellow No. 6.

Pfizer

NDC 0009-0064-04

Provera®
medroxyprogesterone
acetate tablets, USP

2.5 mg

100 Tablets
Rx only

Applies to medroxyprogesterone: compounding powder, intramuscular suspension, oral tablet, subcutaneous suspension

Gastrointestinal

Very common (10% or more): Abdominal pain/discomfort (up to 11.2%)
Common (1% to 10%): Nausea, bloating, abdominal distention, diarrhea, vomiting, constipation
Uncommon (0.1% to 1%): Dry mouth
Postmarketing reports: Gastrointestinal disturbances, rectal bleeding[Ref]

Genitourinary

Very common (10% or more): Amenorrhea (up to 68%), bleeding (up to 57.3%), uterine bleeding irregularities (up to 35%)
Common (1% to 10%): Dysmenorrhea, leukorrhea, vaginitis, intermenstrual bleeding, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial, abnormal cervix smear, metrorrhagia, menometrorrhagia, menstruation irregular, vaginal hemorrhage, erectile dysfunction, genitourinary tract infection, pelvic pain, dyspareunia
Frequency not reported: Uterine cervical erosions, cervical discharge, vulvovaginal dryness, premenstrual syndrome, vaginal cyst, ovarian cyst, lack of return to fertility, sensation of pregnancy
Postmarketing reports: Unexpected pregnancy, uterine hyperplasia, oligomenorrhea, prolonged anovulation[Ref]

Metabolic

Very common (10% or more): Increase weight (up to 37%)
Common (1% to 10%): Increased appetite, decreased appetite
Uncommon (0.1% to 1%): Diabetes mellitus exacerbated, hypercalcemia, fluid retention
Frequency not reported: Elevations of serum calcium and potassium levels, exacerbation of diabetes mellitus
Postmarketing reports: Decreased glucose tolerance, changes in appetite, excessive thirst[Ref]

Weight gain is more frequently encountered than weight loss during medroxyprogesterone therapy. In women using intramuscular medroxyprogesterone for contraception, the mean weight gain after one year of therapy is 2.5 kg. After two, four, and six years, patients gain a mean of 3.7, 6.3, and 7.5 kg, respectively.[Ref]

Nervous system

Very common (10% or more): Nervousness (10.8%)
Common (1% to 10%): Dizziness
Rare (less than 0.1%): Cerebral infarction, somnolence
Frequency not reported: Loss of concentration, adrenergic-like effects, migraine, seizure, VII th nerve paralysis, syncope
Postmarketing reports: Paralysis, facial palsy, paresthesia, drowsiness[Ref]

Other

Very common (10% or more): Headache (up to 16.5%)
Common (1% to 10%): Asthenia, fatigue, edema /fluid retention, breast pain, breast tenderness
Frequency not reported: Chills, fever, vertigo, breast atrophy, breast mass, nipple exudate bloody, breast enlargement
Postmarketing reports: Changes in breast size[Ref]

Cardiovascular

The majority of cases of thromboembolic disease during hormonal therapy have been attributed to estrogens and not to progestogens. However, it has been demonstrated that this drug, at least at high doses, can produce a hypercoagulable state. Whether or not this contributes to the development of thrombotic events remains unknown.[Ref]

Common (1% to 10%): Hot flashes
Uncommon (0.1% to 1%): Cardiac failure congestive, thrombophlebitis
Rare (less than 0.1%): Myocardial infarction, embolism, thrombosis, blood pressure increased
Frequency not reported: Tachycardia, palpitations
Postmarketing reports: Deep vein thrombosis, varicose veins[Ref]

Dermatologic

Common (1% to 10%): Acne, no hair growth/alopecia, rash, hyperhidrosis
Uncommon (0.1% to 1%): Hirsutism, urticaria, pruritus, chloasma
Frequency not reported: Lipodystrophy acquired, dermatitis, ecchymosis, scleroderma, skin striae, erythema multiforme, erythema nodosum
Postmarketing reports: Axillary swelling, excessive sweating and body odor, dry skin, melasma[Ref]

Musculoskeletal

Common (1% to 10%): Leg cramps, arthralgia, back pain, limb pain, pain in extremity
Uncommon (0.1% to 1%): Muscle spasms
Frequency not reported: Gluteal infiltration and abscess formation
Postmarketing reports: Chest pain, osteoporosis including osteoporotic fractures, loss of bone mineral density, scleroderma[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, anxiety, irritability, decreased libido
Uncommon (0.1% to 1%): Euphoria, changes in libido
Rare (less than 0.1%): Confusion
Frequency not reported: Anorgasmia, emotional disturbance, affective disorder,
Postmarketing reports: Increased libido[Ref]

Respiratory

Common (1% to 10%): Bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Pulmonary embolism
Frequency not reported: Dysphonia
Postmarketing reports: Dyspnea, asthma, hoarseness[Ref]

Endocrine

Uncommon (0.1% to 1%): Corticoid-like effects
Frequency not reported: Cushingoid syndrome, galactorrhea
Postmarketing reports: Prevention of lactation with or without hyperprolactinemia[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, jaundice cholestatic
Postmarketing reports: Abnormal liver function test, abnormal hepatic enzyme[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions including angioedema, anaphylactic reaction, anaphylactoid reaction[Ref]

Immunologic

Frequency not reported: White blood cell count increased, platelet count increased
Postmarketing reports: Anemia, blood dyscrasia[Ref]

Local

Frequency not reported: Injection site abscess, injection site infection, injection site nodule/lump, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling[Ref]

Ocular

Frequency not reported: Retinal embolism and thrombosis, cataract diabetic, visual impairment[Ref]

Renal

Frequency not reported: Glycosuria[Ref]

Oncologic

A significant increase in the incidence of breast cancer in beagle dogs in addition to an apparent increase in the incidence of endometrial cancer in rhesus monkeys was noted in early animal carcinogenicity studies.[Ref]

Postmarketing reports: Cervical cancer, breast cancer, endometrial hyperplasia, breast lumps or nipple bleeding, nipple discharge[Ref]

Some side effects of Provera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.