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Menopause

THERAPEUTIC INDICATIONS: Hormone Replacement Therapy.

Treatment of vasomotor symptoms associated with menopause.

Treatment of vulvar and vaginal atrophy. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, consider topical vaginal products.

Prevention and treatment of osteoporosis. When prescribing solely for the prevention and treatment of osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and for those that are not considered a non-estrogen medications.

HRT not be initiated or continued to prevent cardiovascular disease or dementia (see also Special warnings, cardiovascular risk and dementia).

The benefits and risks of HRT must always be weighed carefully, including consideration of the emergence of risks as therapy continues (see Special Warnings). Should be prescribed estrogen with or without progestins at the lowest effective dose and shortest duration consistent with treatment goals and risks for individual women. In the absence of comparable data, it must be assumed that the risks of HRT are similar for all estrogen and combination estrogen / progestin.

PREMELLE * Continuous, is indicated for women with a uterus, with the aim of reducing the risk of endometrial hyperplasia and cancer that is associated when used only conjugated equine estrogen in these patients.

In hysterectomy patients, we recommend treatment with conjugated equine estrogens alone.


Contraindications: Suspected or confirmed pregnancy (see Restrictions of use during pregnancy and lactation).

Undiagnosed abnormal genital bleeding.

Breast cancer known, suspected or previous history.

Suspected or confirmed estrogen-dependent neoplasia (eg endometrial cancer, endometrial hyperplasia).

Active presence or history of confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism).

Arterial thromboembolic disease active or recent (eg, stroke, myocardial infarction).

Liver dysfunction or disease in both liver function tests have not returned to normal.

PREMELLE * not be used in patients hypersensitive to its ingredients.

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