The benefits and risks of estrogen therapy (ET) must always be carefully weighed, including consideration of the emergence of risks as therapy continues (see Precautions). Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
If an estrogen is prescribed for a post-menopausal woman with a uterus, the addition of a progestin may be appropriate (see Malignant Neoplasms under Precautions). In some cases, hysterectomized women with a history of endometriosis may need a progestin (see Exacerbation of other conditions under Precautions).
Tablets should be taken whole; do not divide, crush, chew, or dissolve tablets in mouth.
Vasomotor Symptoms and/or Vulvar and Vaginal Atrophy: Consider topical vaginal products when treating solely for vulvar and vaginal atrophy.
Prevention/Management of Post-menopausal Osteoporosis: When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
Female Hypoestrogenism: Administer cyclically (e.g., three weeks on and one week off).
Usual Dosage Range: VASOMOTOR SYMPTOMS, ATROPHIC VAGINITIS AND ATROPHIC URETHRITIS ASSOCIATED WITH ESTROGEN DEFICIENCY: 0.3 mg - 1.25 mg daily.
OSTEOPOROSIS: 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 5 days off drug), as is medically appropriate on an individualized basis.
FEMALE HYPOESTROGENISM: 0.3 mg - 1.25 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.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Estrogen treatment of prepubertal girls induces premature breast development and vaginal cornification, and may induce uterine bleeding.
Since large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, hormonal therapy should not be started before epiphyseal closure has occurred in order not to compromise final growth.
Use in Elderly Patients: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing estrogens to determine whether those over 65 years of age differ from younger subjects in their response to estrogens.
The Women's Health Initiative Study (WHI): In the WHI estrogen-alone substudy (daily CE [0.625 mg] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age (see Pharmacology: Pharmacodynamics: WHI Studies under Actions).
The Women's Health Initiative Memory Study (WHIMS): In the WHIMS of post-menopausal women 65 to 79 years of age, there was increased risk of developing probable dementia in women receiving estrogen alone when compared to placebo. It is unknown whether this finding applies to younger post-menopausal women (see Pharmacology: Pharmacodynamics: WHIM Study under Actions and Dementia under Precautions).