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Medroxyprogesterone Drug Info
  
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Medroxyprogesterone Drug Info

Generic Name: Medroxyprogesterone Tablets (meh-DROX-ee-pro-JESS-tuh-rone)
Brand Name: Provera

What is Provera (medroxyprogesterone)?

Medroxyprogesterone is a female hormone, usually called "progesterone". It is important for the regulation of ovulation and menstruation.

Medroxyprogesterone 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 medroxyprogesterone 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.

Medroxyprogesterone may also be used for purposes other than those listed in this medication guide.

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

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

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

Do not take medroxyprogesterone 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 medroxyprogesterone, 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 medroxyprogesterone 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.
    Medroxyprogesterone is in the FDA pregnancy category D. This means that medroxyprogesterone 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 medroxyprogesterone enter the milk of mothers receiving medroxyprogesterone. 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.

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