Premarin

Premarin Information

Brand Names: Elredin

Generic Name: Premarin

Other Common Names: Shrogen

Premarin conjugated estrogens is a mixture of estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine.

Estrogens (such as made available in Premarin) are prescribed by doctors for a number of purposes, including:

providing estrogen during a period of adjustment when a woman's ovaries stop producing a majority of her estrogens, in order to prevent certain uncomfortable symptoms of estrogen deficiency. With the menopause, which generally occurs between the ages of 45 and 55, women produce a much smaller amount of estrogens.
preventing symptoms of estrogen deficiency when a woman's ovaries have been removed surgically before the natural menopause.
preventing pregnancy. Estrogens are given along with a progestogen, another female hormone; these combinations are called oral contraceptives, or birth-control pills. Patient labeling is available to women taking oral contraceptives and they will not be discussed in this leaflet.
to treat certain cancers in women and men.
moderate to severe vasomotor symptoms associated with the menopause. There is no adequate evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause and they should not be used to treat these conditions.
atrophic vaginitis
osteoporosis (loss of bone mass). The mainstays of prevention and management of osteoporosis are estrogen and calcium; exercise and nutrition may be important adjuncts. Estrogen replacement therapy is the most effective single modality for the prevention of osteoporosis in women. Estrogen reduces bone resorption and retards or halts postmenopausal bone loss. Case-controlled studies have shown an approximately 60-percent reduction in hip and wrist fractures in women whose estrogen replacement was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass but does not restore it to premenopausal levels. The lowest effective dose for prevention and treatment of osteoporosis should be utilized.

How To Take Premarin and Premarin Dosage and Administration

For treatment of moderate to severe vasomotor symptoms and atrophic vaginitis associated with the menopause. The lowest dose that will control symptoms should be chosen, and medication should be discontinued as promptly as possible.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.

Dosages, according to the conditions that they are indicated for, are as follows:

Vasomotor Symptoms: 1.25 mg daily. If the patient has not menstruated within the last two months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic (e.g., three weeks on and one week off) administration is started on day 5 of bleeding.
Atrophic Vaginitis: 0.3 mg to 1.25 mg or more daily, depending upon the tissue response of the individual patient. Administer cyclically.
Hypoestrogenism due to female hypogonadism: 2.5 mg to 7.5 mg daily, in divided doses for 20 days, followed by a rest period of 10 days' duration. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium.

If bleeding occurs before the end of the 10-day period, begin a 20-day estrogen-progestin cyclic regimen with conjugated estrogens, 2.5 mg to 7.5 mg daily in divided doses, for 20 days. During the last five days of estrogen therapy, give an oral progestin. If bleeding occurs before this regimen is concluded, therapy is discontinued and may be resumed on the fifth day of bleeding.

Female castration or primary Ovarian Failure: 1.25 mg daily, cyclically. Adjust dosage, upward or downward, according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
Osteoporosis (loss of bone mass): 0.625 mg daily. Administration should be cyclic (e.g., three weeks on and one week off).

Vaginal Cream

Given Cyclically for Short-Term Use Only: For treatment of atrophic vaginitis, or kraurosis vulvae.

Administration should be cyclic (e.g., three weeks on and one week off).

Usual Dosage Range: 1/2 to 2 g daily, intravaginally, depending on the severity of the condition. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Use of the Gentle Measure Applicator:

Remove cap from tube.

Screw nozzle end of applicator onto tube.
Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator as a guideline to measure the correct dose.
Unscrew applicator from tube.
Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.

If you suspect a Premarin Overdose

Tablets: Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that acute serious ill effects do not occur. Overdosage of estrogen may cause nausea and vomiting.

Injection and Vaginal Cream: Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that acute serious ill effects do not occur. Overdosage of estrogens may cause nausea, and withdrawal bleeding may occur in females.

Premarin Ingredients and Composition

Premarin Side Effects

Premarin Precautions and Contraindications

The following should be reported to your doctor immidiatly, and the estrogen dose discontinued:

abnormal bleeding from the vagina
pains in the calves or chest, sudden shortness of breath, or coughing blood
severe headache, dizziness, faintness, or changes in vision
breast lumps (you should ask your doctor how to examine your own breasts)
jaundice (yellowing of the skin)
mental depression

Estrogens should not be used in women (or men) with any of the following conditions:

known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease
known or suspected estrogen-dependent neoplasia
known or suspected pregnancy. Estrogen may cause fetal harm when administered to a pregnant woman
undiagnosed abnormal genital bleeding
active thrombophlebitis or thromboembolic disorders
a past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast malignancy)

Estrogen and Menopause

In the natural course of their lives, all women eventually experience a decrease in estrogen production. This usually occurs between ages 45 and 55, but the age at which menopause sets in varies from woman to woman. Sometimes the ovaries may need to be removed before natural menopause by an operation, producing a "surgical menopause."

When the amount of estrogen in the blood begins to decrease, many women may develop typical symptoms: feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating throughout the body (called "hot flashes" or "hot flushes"). These symptoms are sometimes very uncomfortable. Some women may also develop changes in the vagina (called "atrophic vaginitis") that cause discomfort, especially during and after intercourse.

Estrogens can be prescribed to treat these menopause symptoms. It is estimated that considerably more than half of all women undergoing menopause have only mild symptoms or no symptoms at all and, therefore, do not require estrogens. Other women may need estrogens for a few months, while their bodies adjust to lower estrogen levels. Sometimes the need will be for periods longer than six months. In an attempt to avoid overstimulation of the uterus (womb), estrogens are usually given cyclically during each month of use, such as three weeks of pills followed by one week without pills.

Sometimes women experience nervous symptoms or depression during menopause. There is no evidence that estrogens are effective for such symptoms without associated vasomotor symptoms. In the absence of vasomotor symptoms, estrogens should not be used to treat nervous symptoms, although other treatment may be needed.

You may have heard that taking estrogens for long periods (years) after the menopause will keep your skin soft and supple and keep you feeling young. There is no evidence that this is so, however, and such long-term treatment carries important risks.

Taking Premarin during Pregnancy or Breast-feeding

There is no proper use of estrogen in pregnant women.

You should not receive estrogen if you are pregnant. If this should occur, there is a greater than usual chance that the developing child will be born with a birth defect, although the possibility remains fairly small. A female child may have an increased risk of developing cancer of the vagina or cervix later in life (in the teens or twenties). Every possible effort should be made to avoid exposure to estrogens during pregnancy. If exposure occurs, see your doctor.

The use of female sex hormones, both estrogens and progestogens, during early pregnancy may seriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a nonsteroidal estrogen, have an increased risk of developing, in later life, a form of vaginal or cervical cancer that is ordinarily extremely rare.5,6 This risk has been estimated as not greater than 4 per 1,000 exposures.7 Furthermore, a high percentage of such exposed women (from 30% to 90%) have been found to have vaginal adenosis,8-12 epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use of other estrogens, it cannot be presumed they would not induce similar changes. Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb-reduction defects. 13-16 One case-controlled study 16 estimated a 4.7-fold increased risk of limb-reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb-reduction defects in exposed fetuses is somewhat less than 1 per 1,000. In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well-controlled studies that progestogens are effective for these uses. If Premarin (conjugated estrogens) is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation.

Storing Premarin

Store at room temperature (approximately 25° C). Dispense in a well-closed container.

Additional Notes

Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women. Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is currently no evidence that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses.