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 norethindrone 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 you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take norethindrone if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take norethindrone if you are nursing.

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.

Usual Adult Dose for Abnormal Uterine Bleeding:

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:
-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Amenorrhea:

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:
-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Contraception:

0.35 mg orally once a day

Comment:
-This drug should be taken at the same time each day.

Use: Prevention of pregnancy

Usual Adult Dose for Endometriosis:

Initial dose: 5 mg orally once a day for 2 weeks
-Maximum dose: 15 mg/day

Comments:
-The dose should be increased by 2.5 mg/day every 2 weeks until 15 mg is reached.
-Treatment may continue for 6 to 9 months OR until annoying breakthrough bleeding demands temporary termination.

Uses: Treatment of endometriosis

Usual Pediatric Dose for Contraception:

Postpubertal adolescents (under 16 years): 0.35 mg orally once a day

Comments:
-This drug should be used after menarche occurs.
-The dose should be taken at the same time each day.

Use: Prevention of pregnancy

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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.

Norethindrone may cause serious side effects. 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 of norethindrone 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 norethindrone 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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to norethindrone.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking norethindrone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.