PREMARIN (conjugated estrogens) Indications And Clinical Use

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PREMARIN® (conjugated estrogens sustained release tablets) is indicated for the following:

  1. the relief of menopausal and postmenopausal symptoms occurring in naturally or surgically induced estrogen deficiency states including vulvar and vaginal atrophy.
  2. the prevention of osteoporosis in naturally occurring or surgically induced estrogen- deficiency states. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy with PREMARIN should be considered in light of other available therapies (see Boxed Warning) and should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered. For older women who are not experiencing any more acute symptoms of menopause, use in combination with a progestin should only be considered for women who failed on, or were intolerant of, non-estrogen medication. Adequate diet, calcium and vitamin D intake, cessation of smoking, as well as regular physical weight-bearing exercise are required in addition to the administration of PREMARIN. Postmenopausal women require an average of 1000 mg to 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
  3. hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
  4. atrophic vaginitis
  5. vulvar atrophy (with or without pruritis). When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

In patients with an intact uterus, PREMARIN should be prescribed with an appropriate dosage of a progestin for women with intact uteri, in order to prevent endometrial hyperplasia/carcinoma.

Geriatrics (> 65 years of age): See above indications.

Pediatrics (< 16 years of age): Clinical studies have not been conducted in the pediatric population. PREMARIN is not indicated for use in children.