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Prometrium

Pronunciation

Generic Name: progesterone (pro-JES-ter-one)
Brand Name: Prometrium

Prometrium when combined with estrogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Progestin hormones combined with estrogen may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Talk with your doctor if you have questions about the benefits and risks of using Prometrium.

Prometrium should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Prometrium.


Prometrium is used for:

Protecting the lining of the uterus in certain women who are also taking estrogen. It is used to treat certain women who have do not have a menstrual period because of decreased progesterone in the body. It may also be used for other conditions as determined by your doctor.

Prometrium is a progestin hormone. It works by changing the lining of the uterus.

Do NOT use Prometrium if:

  • you are allergic to any ingredient in Prometrium or to peanuts
  • you have known or suspected breast cancer or a history of breast cancer
  • you have abnormal vaginal bleeding of unknown cause
  • you have active blood clots (eg, in the legs or lungs) or a history of blood clots, heart attack, or stroke
  • you have a history of liver problems or liver disease
  • you are pregnant or suspect that you may be pregnant

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Prometrium:

Some medical conditions may interact with Prometrium. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of breast lumps, breast disease, or an abnormal mammogram or if a member of your family has had breast cancer
  • if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, abnormal vaginal bleeding, cancer) or you have had your uterus removed (hysterectomy)
  • if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, thyroid problems, asthma, migraine headaches, or lupus
  • if you have a history of seizures, mental or mood problems (eg, depression), cancer, or tobacco use
  • if a member of your family has had blood clots (eg, in the legs or lungs)
  • if you are very overweight or have high calcium levels in your blood

Some MEDICINES MAY INTERACT with Prometrium. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Efavirenz or rifamycins (eg, rifampin) because they may decrease Prometrium's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prometrium may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prometrium:

Use Prometrium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Prometrium. Talk to your pharmacist if you have questions about this information.
  • Take Prometrium by mouth at bedtime, unless your doctor tells you otherwise. It may be taken with or without food.
  • If you have trouble swallowing Prometrium, take it with a glass of water while in the standing position. Tell your doctor if you continue to have trouble swallowing Prometrium.
  • If you miss a dose of Prometrium, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prometrium.

Important safety information:

  • Prometrium may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Prometrium with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • This product has peanut oil in it. Do not take Prometrium if you are allergic to peanuts.
  • Diabetes patients - Prometrium may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Prometrium or take other special precautions for a period of time.
  • Prometrium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prometrium.
  • Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Prometrium. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Prometrium should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Prometrium if you are pregnant unless your doctor tells you otherwise. If you think you may be pregnant, contact your doctor. Prometrium is found in breast milk. If you are or will be breast-feeding while you use Prometrium, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Prometrium:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; fluid retention; headache; irritability; mild hair loss; muscle pain; nausea; spotting or breakthrough bleeding; stomach pain or cramping; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; coughing up blood; fainting; mental or mood changes (eg, depression, anxiety); migraine or severe headache; new or worsening memory problems; seizures; severe or persistent dizziness; severe or persistent stomach pain or tenderness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; unusual sweating or weakness); symptoms of a stroke (eg, confusion; slurred speech; one-sided weakness); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); trouble walking; unusual vaginal discharge/itching/odor; vision problems or changes (eg, double vision; sudden, partial, or full loss of vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prometrium:

Store Prometrium at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prometrium out of the reach of children and away from pets.

General information:

  • If you have any questions about Prometrium, please talk with your doctor, pharmacist, or other health care provider.
  • Prometrium is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Prometrium or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Prometrium. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prometrium. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Prometrium.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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