What to Know About Provera (medroxyprogesterone acetate)

Provera (medroxyprogesterone acetate) is a hormonal treatment taken by mouth in tablet form that may be prescribed for several conditions that include imbalances of female hormones, including heavy or absent menstrual periods. Provera is in a class of drugs called progestins and is a synthetic form of progesterone—a hormone naturally produced after ovulation (when an egg is released from an ovary). It works by correcting the hormonal balance and regulating ovulation.

Provera is available by prescription only. It's also available in generic form.

Uses

Provera is approved by the Food and Drug Administration (FDA) to treat:

• An abnormal absence of menstrual periods due to another condition (secondary amenorrhea)
• Abnormal uterine bleeding, such as from polycystic ovary syndrome (PCOS), due to hormonal imbalance and not associated with conditions such as fibroid tumors or uterine cancer
• Endometrial hyperplasia (overgrowth of the uterine lining) after menopause, which can increase the risk of uterine cancer

An injectable form of medroxyprogesterone called Depo-Provera is approved as birth control.

Off-Label Uses

Provera is also used for conditions that it hasn't received FDA approval for, including:

• Heavy menstrual bleeding
• Irregular menstrual periods
• Birth control
• Endometriosis
• Endometrial cancer
• Menopause-related symptoms such as hot flashes, night sweats, and vaginal dryness (used along with estrogen)

Before Taking

Your doctor may consider Provera for you if you're diagnosed with any of the conditions it treats, and especially if you can't take estrogen. As part of the diagnosis and treatment process, your doctor will likely perform a pelvic exam and may order numerous tests, including tests for levels of hormones including:

• Progesterone
• Estrogens (estradiol, estriol, and estrone)
• Follicle-stimulating hormone (which stimulates the growth of eggs in the ovary)
• The male hormones testosterone and DHEA
• Thyroid hormones (thyroid-stimulating hormone, thyroxine, triiodothyronine)
• The pregnancy hormone human chorionic gonadotropin (HCG)

Imaging studies used in the diagnostic process may include:

• Ultrasound
• Computerized tomography (CT) scan
• Magnetic resonance imaging (MRI)
• Hysteroscopy (an examination of the uterus via a small camera inserted through the vagina)

The specific tests your doctor orders depend on your symptoms and stage of life (e.g., premenopausal or postmenopausal).

If you've never taken estrogens, you may be given them first for certain conditions and, if you don't tolerate them or they're not effective enough, you may be switched to Provera or have Provera added to your estrogen regimen.

Talk to your doctor about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Precautions and Contraindications

Provera isn't safe for everyone. You shouldn't start taking it if you have:

• Vaginal bleeding with an undiagnosed cause
• Hormone-sensitive cancers (e.g., breast or uterine cancer) or a history of them
• Had a stroke in the past year
• Had a heart attack in the past year
• Blood clots or a history of them
• A bleeding disorder
• Liver problems or a history of them
• A possible or confirmed pregnancy
• A known allergy to medroxyprogesterone or any ingredients in Provera

Also, be sure to tell your doctor:

• If you're planning to become pregnant
• If you're breastfeeding
• If you're planning to have surgery
• If you have any other medical problems

These issues may affect whether you can take Provera, or if a break from the medication may be necessary (such as before surgery).

Conditions that may require closer monitoring while you're taking Provera include:

• Asthma
• Diabetes
• Endometriosis
• Epilepsy
• Heart problems
• High blood calcium levels
• Kidney problems
• Liver problems
• Lupus
• Migraines
• Thyroid disease

Other Progestins

Other progestin drugs on the market include:

• Prometrium (micronized progesterone), which is approved for amenorrhea and, along with estrogens, reducing menopause symptoms
• Oral contraceptives called the "minipill" that contain norethindrone, including brand names Camila, Errin, Heather, Incassia, and Jencycla

Dosage

Provera is available in three dosages:

• 2.5 milligrams (mg)
• 5 mg
• 10 mg

Doctors typically prescribe the lowest effective dose and for the shortest amount of time possible. The dosage used varies by the condition being treated.

Dosages may not be established for off-label uses. Always follow your doctor's instructions for prescription medications.

Modifications

Prescribing Provera for people with significant liver impairment from alcoholic cirrhosis is discouraged. If it is prescribed, the dosage may need to be lowered.

If you take thyroid replacement hormone, your dosage of that medication may need to be adjusted after you start Provera. Your doctor may want you to get more frequent lab work to check your thyroid hormone levels.

How to Take and Store

Because Provera has special timing requirements for most uses, be sure to follow your doctor's instructions for taking it. If you forget to start Provera when you're supposed to, if you miss a dose, or if you have any questions about dosage or timing, talk to your doctor or pharmacist for guidance.

Provera should be stored at room temperature (between 68 degrees and 77 degrees F).

Side Effects

As with any drug, Provera can cause side effects in some people. Some of these are common and not considered dangerous, while others are cause for calling your doctor right away.

Common

Common side effects of Provera don't require immediate medical care, but you should contact your doctor if any of these become severe, don't go away after you've been on the drug for a while, or are a significant problem for you:

• Headaches
• Tender breasts
• Breast milk secretion
• Irregular vaginal bleeding or spotting
• Acne
• Facial hair growth
• Hair loss
• Insomnia
• Tiredness
• Nausea
• PMS symptoms
• Unintended weight loss or gain

Severe

Other, less common side effects may be more serious. Call your doctor immediately or seek emergency medical attention if you experience:

• Pain, swelling, redness, and warmth in one leg
• Difficulty speaking or slow speech
• Dizziness or feeling faint
• Weakness or numbness in a limb
• Shortness of breath
• Coughing up blood
• Sudden sharp or crushing chest pain
• Fast or pounding heartbeat
• Sudden vision changes or blindness
• Double or blurred vision
• Bulging eyes
• Skipped periods
• Depression
• Jaundice (yellow eyes and skin)
• Fever
• Skin rash
• Hives
• Itching
• Difficulty breathing or swallowing
• Swollen face, mouth, tongue, or neck
• Swollen hands, feet, or lower legs

If you take Provera with estrogen, be sure you're aware of the estrogen side effects, as well.

Warnings and Interactions

Provera by itself is not a contraceptive and won't prevent pregnancy. Use another form of birth control, such as a condom, while you're taking this drug. You may not be able to take Provera while also using hormonal birth control.

When Provera is combined with estrogens, the FDA has required that the following serious warnings be included with packaging information:

• Estrogen and progestin should not be used to prevent heart disease or dementia.
• After menopause, estrogen plus progestin may increase your risk of heart attack, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis.
• After age 65, estrogen plus progestin may increase the risk of dementia. (It's unknown whether this risk applies to those under 65.)

Provera may interfere with the results of certain lab tests, including:

• Thyroid hormone levels
• Glucose tolerance
• Cholesterol and triglyceride levels
• Hormone concentrations
• Binding proteins

Drug Interactions

Provera shouldn't be taken with Cytadren (aminoglutethimide) or other CYP3A4 inducers/inhibitors, as they may alter the way your body responds to progestins.

Other drugs may pose problems as well. Be sure your doctor knows everything you're taking, including over-the-counter drugs and nutritional supplements. Using the same pharmacy for all of your prescription medications can help you avoid negative drug interactions.