Premarin

ESTROGENS, CONJUGATED

Manufacturer: A-S Medication Solutions

Score: 148.0

Quick Summary

Premarin is a conjugated estrogen tablet used for the treatment of moderate to severe vasomotor symptoms, vulvar and vaginal atrophy, and hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. It is also used for the prevention of postmenopausal osteoporosis and for the palliation of breast cancer and advanced androgen-dependent carcinoma of the prostate. The medication has several warnings and contraindications, including an increased risk of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia. The recommended dosage varies depending on the condition being treated, and special considerations are needed for use during pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Treatment of moderate to severe vasomotor symptoms due to menopause
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
Prevention of postmenopausal osteoporosis
Palliation of breast cancer and advanced androgen-dependent carcinoma of the prostate

Important Safety Information

Warning

Increased risk of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia

Contraindications

Undiagnosed abnormal genital bleeding
Known, suspected, or history of breast cancer
Known or suspected estrogen-dependent neoplasia
Active DVT, PE, or a history of these conditions
Active arterial thromboembolic disease
Known anaphylactic reaction or angioedema with Premarin
Known liver impairment or disease
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Known or suspected pregnancy

Adverse Reactions

Abdominal pain
Asthenia
Back pain
Headache
Flatulence
Nausea
Depression
Insomnia
Breast pain
Endometrial hyperplasia
Leucorrhea
Vaginal hemorrhage
Vaginitis

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on individual patient response and clinical factors

Moderate to severe vasomotor symptoms due to menopause

Adult Dose

0.3 mg daily, with subsequent dosage adjustment based on individual patient response

Pediatric Dose

Not applicable

Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause

Adult Dose

0.3 mg daily, with subsequent dosage adjustment based on individual patient response

Pediatric Dose

Not applicable

Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure

Adult Dose

0.3 mg or 0.625 mg daily, administered cyclically

Pediatric Dose

Not applicable

Prevention of postmenopausal osteoporosis

Adult Dose

0.3 mg daily, with subsequent dosage adjustment based on individual patient response

Pediatric Dose

Not applicable

Palliation of breast cancer and advanced androgen-dependent carcinoma of the prostate

Adult Dose

10 mg three times daily for breast cancer, and 1.25 mg to 2 x 1.25 mg three times daily for prostate cancer

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

Premarin should not be used during pregnancy
There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy

Nursing Mothers

Premarin should not be used during lactation
Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk
Detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy

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 the completion of physiologic puberty in normally developing children

Geriatric Use

There have not been sufficient numbers of geriatric patients involved in 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 reported a higher relative risk of stroke in women greater than 65 years of age
The Women's Health Initiative Memory Study reported an increased risk of developing probable dementia in postmenopausal women 65 to 79 years of age