Brand Name(s):

Prometrium^®

WHY is this medicine prescribed?

Progesterone is used as a part of hormone replacement therapy in women who have passed menopause (the change of life) and have not had a hysterectomy (surgery to remove the uterus). Hormone replacement therapy usually includes estrogen, which is used to treat symptoms of menopause and reduce the risk of developing certain diseases. However, estrogen can also cause abnormal thickening of the lining of the uterus and increase the risk of developing uterine cancer. Progesterone helps to prevent this thickening and decreases the risk of developing uterine cancer. Progesterone is also used to bring on menstruation (period) in women of childbearing age who have had normal periods and then stopped menstruating. Progesterone is in a class of medications called progestins (female hormones). It works as part of hormone replacement therapy by decreasing the amount of estrogen in the uterus. It works to bring on menstruation by replacing the natural progesterone that some women are missing.

HOW should this medicine be used?

Progesterone comes as a capsule to take by mouth. It is usually taken once a day in the evening or at bedtime. You will probably take progesterone on a rotating schedule that alternates 10 to 12 days when you take progesterone with 16 to 18 days when you do not take the medication. Your doctor will tell you exactly when to take progesterone. To help you remember to take progesterone, take it around the same time in the evening. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take progesterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take progesterone as directed even if you feel well. Do not stop taking progesterone 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 progesterone,

tell your doctor and pharmacist if you are allergic to progesterone, oral contraceptives (birth control pills), hormone replacement therapy, any other medications, or peanuts.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Samdimmune); danazol (Danocrine); delaviridine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S, E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Fortovase); isoniazid (INH, Nydrazid); lansoprazole (Prevacid, Prevpac); metronidazole (Flagyl); nefazodone (Serzone); omeprazole (Prilosec); oral contraceptives (birth control pills); ticlopidine (Ticlid); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had unexplained vaginal bleeding between periods; a miscarriage in which some tissue was left in the uterus; cancer of the breasts or female organs; seizures; migraine headaches; asthma; diabetes; depression; blood clots in the legs, lungs, eyes, brain, or anywhere in the body; stroke or ministroke; vision problems; or liver, kidney, heart, or gallbladder disease .
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking progesterone, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking progesterone.
you should know that progesterone may make you dizzy or drowsy. Do not drive a car or operate machinery until you know how this medication affects you. If progesterone does make you dizzy or drowsy, take your daily dose at bedtime.
you should know that progesterone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking progesterone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medication.

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?

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 (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

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 athttps://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.

Before having any laboratory test or biopsy (removal of tissue for testing), tell your doctor and the laboratory personnel that you are taking progesterone.

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.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2016.