Prometrium General Information

Prometrium is a type of female hormone (progestin). Prometrium is similar to the Prometrium that your body naturally makes and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, Prometrium is used to restore normal menstrual periods that have stopped for several months (amenorrhea).

Prometrium is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Prometrium is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.

Prometrium is not for use in children.

Prometrium must not be used to test for pregnancy.

Prometrium may also be used to maintain pregnancy.

How to Use Prometrium

Read the Patient Information Leaflet provided by your pharmacist before you start using Prometrium and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take Prometrium by mouth, usually once a day at bedtime or as directed by your doctor. If you have trouble swallowing the pills, take with a full glass of water while standing up. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy.

Inform your doctor if your condition does not improve or if it worsens.

Prometrium Possible Side Effects

Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Prometrium because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Prometrium do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine, unusual tiredness.

Prometrium may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.

A very serious allergic reaction to Prometrium is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Prometrium Precautions

Before taking Prometrium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Prometrium may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Prometrium should not be used if you have certain medical conditions. Before using Prometrium, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), recent stroke or heart attack (within 1 year).

Before using Prometrium, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes, lupus.

Prometrium may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.

Do not smoke. Smoking combined with Prometrium further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.

Prometrium may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen, and wear protective clothing when outdoors.

Prometrium may be used during pregnancy only as directed by your doctor. There is conflicting information about whether progestins may cause harm to an unborn baby. Discuss the risks and benefits with your doctor.

Prometrium passes into breast milk. Consult your doctor before breast-feeding.

Prometrium Possible Intercations

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with Prometrium include: drugs affecting liver enzymes that remove Prometrium from your body (such as rifampin, St. John's wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin).

Prometrium can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use Prometrium.

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