Aygestin (Norethindrone) Drug Information: Medication Guide and Patient Information

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May 25, 2012

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What is endometriosis?

Endometriosis is the abnormal growth of cells (endometrial cells) similar to those that form the inside of the uterus, but in a location outside of the uterus. Endometrial cells are cells that are shed each month during menstruation. The cells of endometriosis attach themselves to tissue outside the uterus and are called endometriosis implants. These implants are most commonly found on the ovaries, the Fallopian tubes, outer surfaces of the uterus or intestines, and on the surface lining of the pelvic cavity. They can also be found in the vagina, cervix, and bladder, although less commonly than other locations in the pelvis. Rarely, endometriosis implants can occur outside the pelvis, on the liver, in old surgery scars, and even in or around the lung or brain. Endometrial implants, while they can cause problems, are benign (not cancerous).

Who is affected by endometriosis?

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Aygestin

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PATIENT INFORMATION

Your doctor has prescribed Aygestin (norethindrone acetate) Tablets, USP, a progestin, for you. Aygestin (norethindrone) is similar to the progesterone hormones naturally produced by the body. Progestins are used to treat menstrual disorders and to test if the body is producing certain hormones.

WARNINGS

AYGESTIN (norethindrone) TABLETS SHOULD NOT BE USED IN WOMEN WITH THE FOLLOWING CONDITIONS:

Known or suspected pregnancy.
History of blood clots in the legs, lungs, eyes, brain, or elsewhere, or a past history of these conditions.
Liver impairment or disease.
Known or suspected cancer of the breast.
Undiagnosed vaginal bleeding.
Hypersensitivity to Aygestin (norethindrone) tablets.

The information below relates only to the risk to the unborn child associated with use of progestin during pregnancy, abnormal blood clotting, and eye abnormalities.

Risk to the Fetus

Aygestin tablets should not be used if you are pregnant. Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. 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 1,000 male births and is 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, avoid using the drug during the first trimester of pregnancy.

If you take Aygestin (norethindrone acetate tablets, USP) and later find you were pregnant when you took it, be sure to discuss this with your doctor as soon as possible.

Abnormal Blood Clotting

Use of progestational drugs has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these condition may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using the drug.

Eye Abnormalities

Discontinue medication and call your physician immediately if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

OTHER INFORMATION

For further information on the use, side effects and other risks associated with this product, ask your doctor. If you want more information, ask your doctor to show you the professional labeling. The professional labeling is also published in a book called the Physicians' Desk Reference, which is available in bookstores and public libraries.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.