Norethindrone

What it is used for

Norethindrone acetate is similar to the progesterone hormones naturally produced by the body. What are norethindrone acetate tablets used for? Norethindrone acetate tablets are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

The most important thing to know

Do not use norethindrone acetate if you are pregnant, breastfeeding or are trying to conceive. Do not use norethindrone acetate if you have had a previous blood clot, stroke, or heart attack. Do not use norethindrone acetate if you are postmenopausal.

Who should not take it

You should not take norethindrone acetate tablets if you are postmenopausal, pregnant or breast-feeding. You should not take norethindrone acetate tablets if you have the following conditions: Known or suspected pregnancy. Norethindrone acetate tablets are not indicated 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 norethindrone acetate during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take norethindrone acetate and later find out you were pregnant, talk with your healthcare provider right away.

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. If you have or had cancer of the breast, talk with your healthcare provider about whether you should take norethindrone acetate. Undiagnosed vaginal bleeding Hypersensitivity to norethindrone acetate tablets.

See the end of this leaflet for a list of all of the ingredients in norethindrone acetate tablets. What are the risks associated with norethindrone acetate tablets? Risk to the Fetus Norethindrone acetate tablets should not be used if you are pregnant. Norethindrone acetate tablets are 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 congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using norethindrone acetate tablets during pregnancy. If you take norethindrone acetate tablets and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible. Abnormal Blood Clotting Use of progestational drugs, such as norethindrone acetate, 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 conditions may cause death or serious long-term disability. Call your healthcare provider right away if you suspect you have any of these conditions. He or she may advise you to stop using the drug. Eye Abnormalities Discontinue norethindrone acetate tablets and call your healthcare provider right away if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

These are some of the warning signs of serious side effects with progestin therapy Breast lumps Dizziness and faintness Changes in speech Severe headaches Chest pain Shortness of breath Pains in your legs Changes in vision Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include Headache Breast pain Irregular vaginal bleeding or spotting Stomach/abdominal cramps/bloating Nausea and vomiting Hair loss Other side effects include High blood pressure Liver problems High blood sugar Fluid retention Enlargements of benign tumors of the uterus (“fibroids”) Vagin