PREMARIN TABLET 0.625 mg

TABLET, SUGAR COATED

**4.2 Posology and method of administration** Administration of Premarin may be continuous (e.g., without a break in therapy) or cyclic (e.g., three weeks on and one week off). The lowest effective dose should be administered. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary. Since progestogens are administered to reduce the risk of hyperplastic changes of the endometrium, patients without a uterus do not require a progestogen for this purpose. If an estrogen is prescribed for a postmenopausal woman with a uterus, the addition of a progestin may be appropriate (see section **4.4 Special warnings and precautions for use, Malignant neoplasms** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In some cases, hysterectomized women with a history of endometriosis may need a progestin (see section **4.4 Special warnings and precautions for use, Exacerbation of other conditions** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Tablets should be taken whole; do not divide, crush, chew, or dissolve tablets in mouth. Dosage adjustment may be made based on individual patient response. **Vasomotor symptoms and/or vulvar and vaginal atrophy** - Consider topical vaginal products when treating solely for vulvar and vaginal atrophy. **Female hypoestrogenism** - Administer cyclically (e.g., three weeks on and one week off). **Use in children** 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 Premarin to determine whether those over 65 years of age differ from younger subjects in their response to Premarin. The Women’s Health Initiative Study In the Women’s Health Initiative (WHI) estrogen-alone substudy (daily conjugated estrogens \[CE\] \[0.625 mg\] versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age (see section **5.1 Pharmacodynamic properties, WHI Studies** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The Women’s Health Initiative Memory Study In the Women’s Health Initiative Memory Study (WHIMS) of postmenopausal women 65–79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen alone when compared to placebo. It is unknown whether this finding applies to younger postmenopausal women (see section **4.4 Special warnings and precautions for use, Dementia** and section **5.1 Pharmacodynamic properties, WHIM Study** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Usual dosage range** VASOMOTOR SYMPTOMS, ATROPHIC VAGINITIS AND ATROPHIC URETHRITIS ASSOCIATED WITH ESTROGEN DEFICIENCY: 0.3–1.25 mg daily. OSTEOPOROSIS: 0.3–0.625 mg. 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. FEMALE HYPOESTROGENISM: 0.3–1.25 mg daily. Administer cyclically (e.g., three weeks on and one week off). Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium. Doses of 0.15 mg have been used in girls and are associated with the onset of development of secondary sex characteristics. Dose should be individualized to achieve optimum patient response.