Progesterone is a naturally occurring hormone important for the regulation of ovulation and menstruation. Progesterone is produced in high amounts in females by the ovaries. It is also produced in smaller amounts by the adrenal glands both males and females.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. It is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Do not use progesterone without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You should not use progesterone if you have: abnormal vaginal bleeding, a history of breast cancer, liver disease, or if you have recently had a heart attack, stroke, or blood clot.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Some forms of this medication may contain peanut oil. Do not use this medicine without telling your doctor if you have a peanut allergy.

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.

Use progesterone exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the capsule with a full glass of water. It is best to take the medicine at night because this medicine can make you dizzy or drowsy.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone is sometimes used for only a short time, such as 10 to 12 days during each menstrual cycle. Follow your doctor's dosing instructions very carefully.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using progesterone.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

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

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

• abnormal vaginal bleeding that a doctor has not checked;

• a history of breast cancer;

• liver disease;

• a peanut allergy;

• if you are pregnant;

• if you have had a stroke, heart attack, or blood clot within the past year; or

• if you have recently had an incomplete miscarriage or "missed" abortion.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, circulation problems;

• migraines;

• asthma;

• kidney disease;

• seizures or epilepsy;

• a history of depression; or

• risk factors for coronary artery disease (such as high blood pressure, diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, being overweight).

Do not use progesterone if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medication.

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

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

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

Progesterone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Call your doctor at once if you have:

• unusual vaginal bleeding;

• pain or burning when you urinate;

• a breast lump;

• sudden vision problems, severe headache or pain behind your eyes;

• symptoms of depression (sleep problems, weakness, mood changes);

• severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Common progesterone side effects may include:

• drowsiness, dizziness;

• breast pain;

• mood changes;

• headache;

• constipation, diarrhea, heartburn;

• bloating, swelling in your hands or feet;

• joint pain;

• hot flashes; or

• vaginal 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.

There may be other drugs that can interact with progesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.