Norethindrone Acetate

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Norethindrone is used for birth control (contraception) to prevent pregnancy.

Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of this medicine are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

Norethindrone may also be used for other purposes not listed in this medication guide.

You should not use norethindrone if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use norethindrone if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take norethindrone if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Carefully follow your doctor's dosing instructions about when to start taking norethindrone for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take norethindrone for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take norethindrone for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take norethindrone for endometriosis: Norethindrone is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

Norethindrone can affect the results of certain medical tests. Tell any doctor who treats you that you are using norethindrone.

Store this medication at room temperature away from moisture, heat, and light.

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of norethindrone is not expected to be dangerous.

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking norethindrone for contraception.

Norethindrone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs can make norethindrone less effective, which may result in unintended pregnancy if you use this medicine for contraception. Tell your doctor about all your other medicines, especially:

• St. John's wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

This list is not complete. Other drugs may affect norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about norethindrone.