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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. |