April 21, 2014
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Drug Factsheets

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Prometrium

(progesterone (for hormone replacement therapy))

DIN (Drug Identification Number)

02166704 PROMETRIUM 100MG CAPSULE

What side effects are possible with Prometrium?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain or cramping
  • acne
  • bloating or swelling of ankles or feet
  • blood pressure increase (mild)
  • breast pain or tenderness
  • brown spots on exposed skin, possibly long-lasting
  • dizziness
  • drowsiness
  • headache (mild)
  • hot flashes
  • loss of sexual desire
  • loss or gain of body, facial, or scalp hair
  • mood changes
  • nervousness
  • swelling of face, ankles, or feet
  • trouble sleeping
  • unusual or rapid weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • changes in vaginal bleeding, such as:
    • heavier vaginal bleeding between regular monthly periods
    • increased amounts of menstrual bleeding occurring at regular monthly periods
    • lighter vaginal bleeding between menstrual periods
    • stopping of menstrual periods
  • depression
  • skin rash
  • symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)
  • unexpected or increased flow of breast milk

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • headache or migraine
  • loss of or change in speech, coordination, or vision
  • numbness of or pain in chest, arm, or leg
  • unexplained shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Prometrium?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Important information about estrogen:

  • Estrogen should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible.
  • You should not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.

Breast cancer: Several studies have shown an association between a modest increase in the risk of developing breast cancer and the use of hormone replacement therapy during menopause when taken over the long term. Ask your doctor which breast cancer screening tests you may need and how to perform breast self-examination.

Occupational hazards: Temporary and occasional drowsiness or dizziness may occur for some people one to four hours after taking progesterone, particularly if it is taken with food. If this occurs, avoid activities requiring concentration, good coordination, or reflex action such as driving or operating machinery. In most cases, these problems can be prevented by taking the capsules at the recommended times. The 200 mg dosage should be taken at bedtime. The 300 mg dosage should be divided into two doses: 100 mg 2 hours after breakfast and 200 mg at bedtime.

Vaginal bleeding: If you have abnormal vaginal bleeding, contact your doctor.

Pregnancy: Do not take progesterone during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking progesterone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

What other drugs could interact with Prometrium?

There may be an interaction between progesterone and any of the following:

  • barbiturates (e.g., phenobarbital)
  • carbamazepine
  • colchicine
  • dabigatran
  • everolimus
  • ketoconazole
  • phenytoin
  • rifabutin
  • rifampin
  • topotecan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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