Premarin is a medicine that contains a mixture of estrogen hormones.

Premarin is used after menopause to:

• reduce moderate to severe hot flashes. Estrogens are hormones made by a woman's
ovaries. The ovaries normally stop making estrogens when a woman is between 45 and
55 years old. This drop in body estrogen levels causes the"change of life" or menopause
(the end of monthly menstrual periods). Sometimes both ovaries are removed during an
operation before natural menopause takes place. The sudden drop in estrogen levels
causes "surgical menopause".When the estrogen levels begin dropping, some women get
very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or
sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some
women the symptoms are mild, and they will not need to take estrogens. In other women,
symptoms can be more severe. You and your healthcare provider should talk regularly
about whether you still need treatment with Premarin.

• treat moderate to severe dryness, itching, and burning, in and around the vagina.

When Premarin is prescribed for a postmenopausal woman with a uterus, progestin should also be
initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need
progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest
effective dose and for the shortest duration consistent with treatment goals and risks for the
individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., at
3-month to 6-month intervals) to determine if treatment is still necessary For women with a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases
of undiagnosed persistent or recurring abnormal vaginal bleeding.

Premarin may be taken without regard to meals.
1. For treatment of moderate-to-severe vasomotor symptoms and/or moderate-to-severe
symptoms of vulvar and vaginal atrophy associated with the menopause:
When prescribing solely for the treatment of moderate-to-severe symptoms of vulvar and vaginal
atrophy, topical vaginal products should be considered.
Patients should be treated with the lowest effective dose. Generally, women should be started at
0.3 mg Premarin daily. Subsequent dosage adjustment may be made based upon the individual
patient response. This dose should be periodically reassessed by the healthcare provider.
Premarin therapy may be given continuously, with no interruption in therapy, or in cyclical
regimens (regimens such as 25 days on drug followed by five days off drug), as is medically
appropriate on an individualized basis.

2. For prevention of postmenopausal osteoporosis:
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be
considered only for women at significant risk of osteoporosis and for whom non-estrogen
medications are not considered to be appropriate. Patients should be treated with the lowest
effective dose. Generally, women should be started at 0.3 mg Premarin daily. Subsequent dosage
adjustment may be made based upon the individual clinical and bone mineral density responses.
This dose should be periodically reassessed by the healthcare provider.
Premarin therapy may be given continuously, with no interruption in therapy, or in cyclical
regimens (regimens such as 25 days on drug followed by five days off drug), as is medically
appropriate on an individualized basis.

3. For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian
failure:
Female hypogonadism — 0.3 mg or 0.625 mg daily, administered cyclically (e.g., three weeks
on and one week off). Doses are adjusted depending on the severity of symptoms and
responsiveness of the endometrium.
In clinical studies of delayed puberty due to female hypogonadism, breast development was
induced by doses as low as 0.15 mg. The dosage may be gradually titrated upward at 6-to-
12 month intervals as needed to achieve appropriate bone age advancement and eventual
epiphyseal closure. Clinical studies suggest that doses of 0.15 mg, 0.3 mg, and 0.6 mg are
associated with mean ratios of bone age advancement to chronological age progression
(ΔBA/ΔCA) of 1.1, 1.5, and 2.1, respectively. (Premarin in the dose strength of 0.15 mg is not
available commercially). Available data suggest that chronic dosing with 0.625 mg is sufficient
to induce artificial cyclic menses with sequential progestin treatment and to maintain bone
mineral density after skeletal maturity is achieved.
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.

4. For treatment of breast cancer, for palliation only, in appropriately selected women and men
with metastatic disease:
Suggested dosage is 10 mg three times daily, for a period of at least three months.

5. For treatment of advanced androgen-dependent carcinoma of the prostate, for palliation only:
1.25 mg to 2 x 1.25 mg three times daily. The effectiveness of therapy can be judged by
phosphatase determinations as well as by symptomatic improvement of the patient.

Premarin therapy is indicated in the:
1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with
the menopause. When prescribing solely for the treatment of symptoms of vulvar and
vaginal atrophy, topical vaginal products should be considered.
3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian
failure.
4. Treatment of breast cancer (for palliation only) in appropriately selected women and men
with metastatic disease.
5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation
only).
6. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention
of postmenopausal osteoporosis, therapy should only be considered for women at
significant risk of osteoporosis and for whom non-estrogen medications are not
considered to be appropriate.

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing
exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic
therapy. Postmenopausal women require an average of 1500 mg/day of elemental for women with suboptimal dietary intake. Vitamin D supplementation may also be required to ensure adequate daily intake in postmenopausal women.

CONTRAINDICATIONS
Estrogens should not be used in individuals with any of the following conditions:
1. Undiagnosed abnormal genital bleeding.
2. Known, suspected, or history of cancer of the breast except in appropriately selected
patients being treated for metastatic disease.
3. Known or suspected estrogen-dependent neoplasia.
4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
5. Active or recent arterial thromboembolic disease, stroke or
myocardial infarction.
6. Liver dysfunction or disease.
7. Premarin tablets should not be used in patients with known hypersensitivity to their
ingredients.
8. Known or suspected pregnancy. There is no indication for Premarin in pregnancy. There
appears to be little or no increased risk of birth defects in children born to women who
have used estrogen and progestins from oral contraceptives inadvertently during
pregnancy.
calcium. Therefore, when not contraindicated, calcium supplementation may be helpful

Pediatric Use
Estrogen therapy has been used for the induction of puberty in adolescents with some forms of
pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established.
Large and repeated doses of estrogen over an extended time period have been shown to
accelerate epiphyseal closure, which could result in short stature if treatment is initiated before
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the completion of physiologic puberty in normally developing children. If estrogen is
administered to patients whose bone growth is not complete, periodic monitoring of bone
maturation and effects on epiphyseal centers is recommended during estrogen administration.
Estrogen treatment of prepubertal girls also induces premature breast development and vaginal
cornification, and may induce vaginal bleeding. In boys, estrogen treatment may modify the
normal pubertal process and induce gynecomastia.

OVERDOSAGE
Serious ill effects have not been reported following acute ingestion of large doses of estrogencontaining
drug products by young children. Overdosage of estrogen may cause nausea and
vomiting, and withdrawal bleeding may occur in females.

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