PREMARIN

Estrogens, Conjugated

Patient Information for PREMARIN

Using Premarin: Premarin (conjugated estrogens) contains a mixture of estrogens obtained exclusively from natural sources. This page describes when and how to use estrogens and the risks of estrogen treatment. Please read it carefully. If you want to know more or have any questions, please ask your doctor or pharmacist.

Treatment and Prevention of Postmenopausal Osteoporosis: Be sure to read this carefully before beginning risedronate therapy.

Estrogen Drugs:

Estrogens have several important uses but also some risks. You must decide, with your doctor, if the benefits of estrogen outweigh any risks. If you decide to start taking estrogens, check with your doctor to make sure you are using the lowest possible effective dose. The length of treatment with estrogens will depend upon the reason for use. This should also be discussed with your doctor.

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Uses of Estrogen:

1. To reduce menopausal symptoms:
   Estrogens are hormones produced by the ovaries. The decrease in the amount of estrogen that occurs in all women, usually between the ages 45 and 55, marks the beginning of the menopause. Sometimes the ovaries are removed by an operation, causing “surgical menopause”. When the amount of estrogen begins to decrease, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden intense episodes of heat and sweating (“hot flashes”).
   
   In some women the symptoms are mild; in others they can be severe. These symptoms may last only a few months or longer. Taking Premarin can alleviate these symptoms. If you are not taking estrogen for other reasons, such as the prevention of osteoporosis, you should take Premarin only as long as you need it for relief from your menopausal symptoms.
2. To Prevent Osteoporosis (Brittle Bones): After age 40, and especially after menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and more likely to break, often leading to fractures of vertebrae, hip, and wrist bones. Taking estrogens after the menopause slows down bone loss and may prevent bones from breaking. Eating foods that are high in calcium (such as milk products) or taking calcium supplements (1,000 to 1,500 mg/day) and certain types of exercise may also help prevent osteoporosis. Since estrogen use is associated with some risk, its use in the prevention of osteoporosis should be confined to women who appear to be susceptible to this condition. The following characteristics are often present in women who are likely to develop osteoporosis: white and Asian races, slim, family history of osteoporosis, physical inactivity, excessive caffeine intake, cigarette smoking, alcohol abuse, below average calcium intake, early menopause.
   
   Women who had their menopause by the surgical removal of their ovaries at a relatively young age are good candidates for estrogen replacement therapy to prevent osteoporosis.
3. To treat certain types of abnormal uterine bleeding due to hormonal imbalance when your doctor has found no serious cause of the bleeding.
4. To treat atrophic vaginitis (itching, burning, dryness in or around the vagina).
5. To treat vulvar atrophy.

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Uses of Progestins:

Progestins used in hormone replacement therapy have similar effects to the female sex hormone progesterone. During the childbearing years, progesterone is responsible for regulation of the menstrual cycle. Premarin not only relieves your menopausal symptoms, but, like estrogens produced by your body, may also stimulate growth of the inner lining of the uterus, the endometrium. In menopausal and postmenopausal women with an intact uterus, stimulation of growth of the endometrium may result in irregular bleeding. In some cases this may progress into a disorder of the uterus known as endometrial hyperplasia (overgrowth of the lining of the uterus). The development of estrogen-mediated disorders of the uterus can be reduced if a progestin is given regularly for a certain number of days with your estrogen replacement therapy.

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Precautions: Although estrogens provide health benefits, certain precautions should be taken before their use and in some situations their use may not be appropriate.

The use of estrogens has been reported to increase the risk of cancer of the lining of the uterus (endometrial cancer) in women after the menopause. This risk is significantly reduced when estrogen is used along with a progestin. If you have had your uterus removed by a hysterectomy, uterine cancer is not a risk for you and administration of a progestin is not necessary.

Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. However, some published epidemiologic studies have documented an association between a modest increase in the risk of developing breast cancer and the use of hormone replacement therapy in menopause when given for periods exceeding 10 years. Therefore, women with a family history of breast cancer, or with breast nodules, fibrocystic breast disease (lumps), or abnormal mammograms should consult with their doctor before starting hormone replacement therapy. Regular breast examinations by a physician and self-examinations are recommended for all women.

The use of oral estrogens after menopause has been reported to increase the risk of gallbladder disease requiring surgery.

Women on estrogen replacement therapy, taken alone or in combination with a progestin, have been reported in some studies to have an increased risk of thrombophlebitis, and/or thromboembolic disease. You should alert the physician if any of the following symptoms occur: changes in vision, tightness in chest, shortness of breath, severe pain in one or both legs, numbness affecting one side or one part of the body, and first migraine.

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Restrictions On Use:

Certain medical conditions may be aggravated by estrogens, therefore estrogens should either not be used at all or should be used with precaution under these conditions.

Estrogens should not be used during pregnancy. Since pregnancy may be possible early in the premenopause while you are still having spontaneous periods, the use of nonhormonal birth control should be discussed with your physician at this time. If you accidentally take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.

Estrogens should not be used if you are breast-feeding.

You should not use Premarin if you have had any unusual allergic reaction to its ingredients. Before using Premarin, be sure to tell your doctor if you have any of the following medical problems. Premarin should not be used under these conditions:

• cancer of the breast or uterus
• unexpected or unusual vaginal bleeding
• stroke
• serious liver disease
• active phlebitis

To help your doctor decide whether you should use Premarin and what precautions should be taken during use, tell your doctor:

• what other prescription and nonprescription medicines, if any, you are taking. There are some medicines which interfere with the effects of estrogens;
• about your allergies or sensitivities to medicines or any other substances you may have;
• if you have ever had any of the following:
• high blood pressure
• heart, kidney, or liver disease
• asthma
• epilepsy or other neurological disorders
• sugar diabetes
• depression
• abnormalities of the breast or uterus including cancer
• breast disease, breast biopsies
• uterine fibroids
• phlebitis (inflamed veins)
• stroke, heart attack or blood clot
• migraine headache
• high triglyceride levels.

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Side Effects:

The following effects have been reported in women taking estrogens (these include estrogens used for birth control). Check with your doctor if these symptoms become troublesome.

• nausea
• retention of fluid
• migraine headaches
• localized darkening of the skin
• breast tenderness and excessive vaginal secretions (may be a sign that too much estrogen is being taken)
• persistent upper abdominal pain, nausea, vomiting, tender abdomen (may be signs of gallbladder disease)
• easy bruising, excessive nose bleeds, excessive heavy periods (may be signs of abnormal blood clotting)
• lower abdominal pain or swelling, painful and/or heavy periods (may be signs of growth of fibroids in the uterus)
• yellowing of the eyes or skin (may be signs of jaundice)
• upper abdominal pain or swelling (may be signs of liver tumors).

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

• irregular vaginal bleeding
• intolerable breast tenderness
• breast enlargement or lumps
• pain or heaviness in the legs or chest
• severe headaches
• dizziness
• changes in vision
• persistent or severe skin irritation
• fluid retention or bloating persisting for more than 6 weeks
• inflammation of the pancreas

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Check with your doctor immediately if you experience:

• shortness of breath
• tightness of the chest
• severe pain in one or both legs or very marked numbness suddenly affecting one side or one part of the body
• sudden change in vision
• first migraine
• any other unusual symptom

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How Supplied:

Premarin tablets for oral administration are available as follows: Tablets: 0.3 mg (green), 0.625 mg (maroon), 0.9 mg (pink), 1.25 mg (yellow).

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