Provera

Provera is a prescription hormone medication used to treat menstrual periods that have stopped or abnormal vaginal bleeding. It is also used to prevent an overgrowth of the lining of the uterus in women taking estrogen who have gone through menopause. Provera works by replacing progesterone hormone that the body is unable to make.

This medication comes in tablet form and is taken once daily for a certain amount of days in a row (decided by your doctor) each month.

Common side effects include breast tenderness, spotting, and headaches.

Provera is a prescription medicine used to:

• treat menstrual periods that have stopped or to treat abnormal uterine bleeding. 
• reduce the chances of getting cancer of the uterus in women after menopause.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pharmacia and Upjohn Company

The following side effects have been reported with the use of Provera alone:

• Breast tenderness
• Breast milk secretion
• Breakthrough bleeding
• Spotting (minor vaginal bleeding)
• Irregular periods
• Amenorrhea (absence of menstrual periods)
• Vaginal secretions
• Headaches
• Nervousness
• Dizziness
• Depression
• Insomnia, sleepiness, fatigue
• Premenstrual syndrome-like symptoms
• Thrombophlebitis (inflamed veins)
• Blood clot
• Itching, hives, skin rash
• Acne
• Hair loss, hair growth
• Abdominal discomfort
• Nausea
• Bloating
• Fever
• Increase in weight
• Swelling
• Changes in vision and sensitivity to contact lenses

Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck.

The following side effects have been reported with the use of Provera with an estrogen.

Side effects are grouped by how serious they are and how often they happen when you are treated:

Serious, but less common side effects include:

• heart attack
• stroke
• blood clots
• dementia
• breast cancer
• cancer of the uterus
• cancer of the ovary
• high blood pressure
• high blood sugar
• gallbladder disease
• liver problems
• changes in your thyroid hormone levels
• enlargements of benign tumors ("fibroids")

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• new breast lumps
• unusual vaginal bleeding
• changes in vision and speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
• memory loss or confusion

Less serious, but common side effects include:

• headache
• breast pain
• irregular vaginal bleeding or spotting
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection

These are not all the possible side effects of Provera with or without estrogen. For more information, ask your healthcare provider or pharmacist.

Talk with your healthcare provider regularly about whether you should continue taking Provera. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).

• See your healthcare provider right away if you get vaginal bleeding while taking Provera.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.

Do not start taking Provera if you:

• have undiagnosed vaginal bleeding.
• currently have or have had certain cancers.
  • Estrogen plus progestin may increase your chance of getting certain cancers, including cancer of the breast. If you have or have had cancer, talk with your healthcare provider about whether you should use Provera.

• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• currently have or have had liver problems.
• think you may be pregnant.
  • Tell your healthcare provider if you think that you may be pregnant or having a miscarriage. There may be an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. If you take Provera and later find out you were pregnant when you took it, be sure to discuss this with your doctor as soon as possible. Provera should not be used as a test for pregnancy.

• are allergic to any of the ingredients in Provera.

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.

Tell your healthcare provider:

• If you are breastfeeding. The hormone in Provera can pass into your breast milk.
• About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing); epilepsy (seizures); migraine headaches; endometriosis (severe pelvic pain); lupus; problems with your heart, liver, thyroid, or kidneys; or if you have high calcium levels in your blood. 
• If you are going to have surgery or will be on bed rest. If you are taking estrogen in addition to Provera, you may need to stop taking estrogen and Provera.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Provera works. Provera may also affect how other medicines work.

Provera should not be taken during pregnancy. Tell your healthcare provider right away if you become pregnant while receiving Provera. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Provera falls into category X. These medicines should never be used by pregnant women.

Tell your healthcare provider if you are breastfeeding. 

Provera has been detected in human breast milk and should not be used while breastfeeding.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Absence of menstrual period: Provera may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.

Abnormal Uterine Bleeding: Provera may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.

Overgrowth of the lining of the uterus: When used in combination with oral conjugated estrogens in postmenopausal women with a uterus, Provera may be given in doses ranging from 5 or 10 mg daily for 12 to 14 straight days per month.

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

Store Provera at room temperature 20° to 25°C (68° to 77°F).

Keep Provera and all medicines out of the reach of children.

WARNINGS

CARDIOVASCULAR AND OTHER RISKS

Estrogens with progestins should not be used for the prevention of cardiovascular disease or dementia. 

The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. 

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.