Norethindrone

Norethisterone acetate

WHY is this medicine prescribed?

Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones.

HOW should this medicine be used?

Norethindrone comes as a tablet to take by mouth. Norethindrone is taken on different schedules that depend on the condition that is being treated and on how well norethindrone works to treat the conditions. When norethindrone is used to treat endometriosis, it is usually taken once a day for 6 to 9 months or until breakthrough bleeding becomes bothersome. When norethindrone is used to bring on a normal cycle in women who have stopped menstruating, it is usually taken once a day for 5 to 10 days during the second half of the planned menstrual cycle. To help you remember to take norethindrone, take it at around the same time of day every day that you are scheduled to take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take norethindrone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking norethindrone for endometriosis, your doctor will probably start you on a low dose of norethindrone and gradually increase your dose, not more than once every 2 weeks.

Norethindrone may control your condition but will not cure it. Continue to take norethindrone even if you feel well. Do not stop taking norethindrone without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking norethindrone,

• tell your doctor and pharmacist if you are allergic to norethindrone, oral contraceptives ('birth control pills'), any other medications, or any of the ingredients in norethindrone tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking norethindrone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..
• the following herbal product may interact with norethindrone: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking norethindrone. Do not start any of these medications while taking norethindrone without discussing with your healthcare provider.
• tell your doctor if you have or have ever had a heart attack; a stroke or mini-stroke; breast cancer; unexplained abnormal vaginal bleeding; blood clots in your legs, lungs, or eyes; or liver disease or any other type of liver problem. Your doctor will probably tell you not to take norethindrone.
• tell your doctor if you have or ever had coronary artery disease (clogged blood vessels leading to the heart), chest pain, thrombophilia (a condition in which the blood clots more easily), seizures, migraine headaches, depression, high blood pressure, high cholesterol, diabetes, lupus (a condition in which the body attacks its own tissues causing damage and swelling), or heart or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking norethindrone, call your doctor immediately. Norethindrone should never be used to test for pregnancy.
• tell your doctor if you smoke or use tobacco products. Smoking may increase the risk that you will develop serious side effects of norethindrone.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Norethindrone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• irregular vaginal bleeding or spotting
• changes in menstrual flow
• enlarged or tender breasts
• nausea
• vomiting
• bloating
• weight changes
• difficulty falling asleep or staying asleep
• acne
• brown patches on the face
• hair loss
• growth of hair on face

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• loss of vision
• blurred vision
• double vision
• bulging eyes
• migraine headache
• pain, warmth, or heaviness in the back of the lower leg
• shortness of breath
• coughing up blood
• sudden sharp or crushing chest pain
• heaviness in chest
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• swelling of the arms, hands, feet, ankles, or lower legs
• yellowing of the skin or eyes
• depression
• mood swings
• missed periods
• sudden, severe pain in the abdomen (area between the chest and waist)
• hives
• rash
• itching
• difficulty breathing or swallowing

Norethindrone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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 (https://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. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2022.