Generic Name: ESTROGENS - ORAL
Pronounced: (ESS-trow-jens)

Premarin Oral Warning

Estrogens given alone and with another hormone (progestin) for replacement therapy after menopause have sometimes caused rare but very serious side effects. Discuss the risks and benefits of hormone treatment and your personal health history with your doctor.

Estrogens have been reported to increase the chance of cancer of the uterus (endometrial cancer). Taking a progestin with estrogen decreases this risk. Tell your doctor immediately if you have any unusual vaginal bleeding.

Estrogens may also increase your risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs. Estrogen given in combination with progestin can infrequently cause heart disease (e.g., heart attacks), stroke, serious blood clots (pulmonary embolism and deep venous thrombosis), dementia, and cancer of the breast. Some of these risks appear to depend on the length of time this drug is used and the amount of estrogen per dose. Therefore, this medication should be used for the shortest possible length of time at the lowest effective dose, so you can obtain the benefits and reduce the chance of serious side effects from long-term treatment. Discuss the details with your doctor and check with him/her regularly (e.g., every 3 to 6 months) to see if you still need to take this medication.

Estrogen treatment alone does not appear to increase your risk of breast cancer when used for up to 7 years after menopause. However, talk to your doctor about the risks if you need to take estrogen for a longer period.

Products that contain estrogen should not be used to prevent heart disease or dementia.

If you use this drug for an extended period, you should have a complete physical exam at regular intervals (e.g., once a year) or as directed by your doctor. See Notes section.

Premarin Oral Side Effects

Dizziness, lightheadedness, headache, stomach upset, bloating, nausea, weight changes, increased/decreased interest in sex, or breast tenderness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• mental/mood changes (e.g., severe depression, memory loss)
• breast lumps
• swelling of hands/feet
• unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/recurrent bleeding)
• unusual vaginal discharge/itching/odor
• yellowing eyes/skin
• stomach/abdominal pain
• persistent nausea/vomiting
• dark urine
• worsening of seizures
• signs of worsening diabetes control (e.g., increased thirst and urination)

This medication may infrequently cause serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following:

• chest/jaw/left arm pain
• sudden severe headache
• weakness on one side of the body
• confusion
• slurred speech
• sudden vision changes (e.g., double vision, loss of vision)
• pain/redness/swelling of legs
• trouble breathing
• coughing up blood
• sudden dizziness/fainting

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Premarin Oral Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• vaginal bleeding of unknown cause
• certain cancers (e.g., breast cancer-especially non-metastatic type, cancer of the uterus or ovaries)
• current/history of blood clots
• history of stroke or heart attack
• liver disease

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• family medical history (especially breast lumps and cancer)
• asthma
• diabetes
• seizures
• migraine headaches
• heart disease (e.g., high blood pressure, congestive heart failure)
• kidney disease
• underactive thyroid (hypothyroidism)
• a certain hormone problem (hypoparathyroidism)
• mineral imbalance (low calcium blood level)
• mental/mood disorders (e.g., dementia, depression)
• high blood pressure during pregnancy (toxemia)
• yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use
• uterus problems (e.g., uterine fibroids, endometriosis)
• high blood cholesterol/fat (triglyceride) levels
• gallbladder disease
• obesity
• certain blood disorder (porphyria)
• lupus

This drug may make you dizzy. 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.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not smoke cigarettes or use tobacco. Estrogens combined with smoking further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.

If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may need to be taken because of the increased risk for blood clots.

Caution is advised if this medicine is used in children. It may affect their growth/development. Discuss the possible effects of this medication with your doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. It may result in birth defects or cancer later in the child's life. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication is not effective for preventing a miscarriage and should not be used for this purpose.

Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.