What is the most important information I should know about Provera?

• Do not take Provera if you are pregnant or planning to become pregnant. It could affect the development of your baby.

What is Provera?

• Provera is a female hormone, usually called “progesterone”. It is important for the regulation of ovulation and menstruation.
• Provera is used to treat conditions such as irregular or abnormal uterine bleeding and lack of menstruation.
• Progesterone or progesterone-like drugs have been used to prevent miscarriage in the first few months of pregnancy. No adequate evidence is available to show that they are effective for this purpose. Furthermore, most cases of early miscarriage are due to causes which could not be helped by these drugs.
• These drugs have been used as a test for pregnancy but such use is not longer considered safe because of possible damage to a developing baby. Also, more rapid methods for testing for pregnancy are now available.
• The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus Provera acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
• Provera may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Provera?

• Do not take Provera without the approval of your doctor if you have
  • a bleeding or blood-clotting disorder,
  • any type of breast or uterine cancer, or
  • liver or gallbladder disease.
• Before taking this medication, tell your doctor if you have
  • epilepsy or a seizure disorder,
  • migraines,
  • asthma,
  • kidney disease,
  • heart disease, or
  • diabetes.
• You may not be able to take Provera, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
• The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus Provera acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
• Provera is in the FDA pregnancy category D. This means that Provera is known to harm an unborn baby. There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and genital abnormalities in male and female babies. The risk to the male baby is the possibility of being born with a condition in which the opening of the penis is on the underside rather than the tip of the penis (hypospadias). Hypospadias occurs in about 5 to 8 per 1000 male births and about doubled with exposure to these drugs. There is not enough information to quantify the risk to exposed female fetuses, but enlargement of the clitoris and fusion of the labia may occur, although rarely.
• Therefore, since drugs of this type may induce mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus, it is wise to avoid using the drug during the first trimester of pregnancy. Do not take this medication if you are pregnant or if you are planning a pregnancy.
• Detectable amounts of Provera enter the milk of mothers receiving Provera. The effect on the nursing infant has not been determined. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Provera?

• Take Provera exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take Provera with food or milk to lessen stomach upset.
• Try to take your doses at the same time each day. Provera is usually taken for a certain number of days each month according to your body's natural cycle.
• Store Provera at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• A Provera overdose is unlikely to threaten life. Call an emergency room or poison control left for advice.
• Symptoms of a Provera overdose include nausea, vomiting, fluid retention (swelling of the hands and feet), breast discomfort, and vaginal bleeding.

What should I avoid while taking Provera?

• Avoid smoking while taking Provera. Smoking greatly increases the risk of blood clot formation.
• Avoid excessive salt intake. Too much salt may cause fluid retention and discomfort.
• Avoid prolonged exposure to sunlight. Provera may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What are the possible side effects of Provera?

• Stop taking Provera and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:
  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • shortness of breath or pain in your chest;
  • a sudden severe headache;
  • visual changes;
  • a painful, red, swollen leg;
  • numbness or tingling in an arm or leg;
  • prolonged, heavy, vaginal bleeding;
  • stomach or side pain; or
  • yellowing of your skin or eyes.
• Other, less serious side effects may be more likely to occur. Continue to take Provera and talk to your doctor if you experience
  • changes in appetite or weight,
  • swelling of your hands or feet,
  • changes in your menstrual cycle,
  • depression,
  • acne,
  • an increase in body or facial hair or hair loss,
  • tenderness of the breasts,
  • nausea,
  • headache or insomnia,
  • changes in your voice, or
  • areas of darker skin.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Provera?

• Before taking Provera, tell your doctor if you are taking any of the following medications:
  • insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), chlorpropamide (Diabinese), tolazamide (Tolinase), and tolbutamide (Orinase);
  • bromocriptine (Parlodel);
  • aminoglutethimide (Cytadren);
  • phenobarbital (Solfoton, Luminal); or
  • chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), promazine (Sparine), thioridazine (Mellaril), or trifluoperazine (Stelazine).
• You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Provera. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

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