Estrogens,drug info
estrogens, conjugated (USP) 0.3 MG Oral Tablet
What it is used for
PREMARIN is a mixture of estrogens indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure
Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease
Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only)
Prevention of Postmenopausal Osteoporosis
1.1 Treatment of
Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of
Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
1.3 Treatment of
Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure
1.4 Treatment of
Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease
1.5 Treatment of
Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only)
1.6 Prevention of
Postmenopausal Osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 4, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
PREMARIN ® (conjugated estrogens tablets, USP) for oral administration contains a mixture of CE purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains concomitant components as sodium sulfate conjugates, 17α-dihydroequilin, 17α estradiol, and 17β-dihydroequilin. Tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg strengths of CE. PREMARIN 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose, and titanium dioxide. Each tablet strength contains the following colors: Tablet strength Tablet color contains 0.3 mg D&C Yellow No. 10 and FD&C Blue No. 2 0.45 mg FD&C Blue No. 2 0.625 mg FD&C Blue No. 2 and FD&C Red No. 40 0.9 mg D&C Red No. 30 and D&C Red No. 7 1.25 mg Black iron oxide, D&C Yellow No. 10 and FD&C Yellow No. 6 PREMARIN tablets comply with USP Dissolution Test criteria, as outlined below: PREMARIN 1.25 mg tablets USP Dissolution Test 4 PREMARIN 0.3 mg, 0.45 mg and 0.625 mg tablets USP Dissolution Test 5 PREMARIN 0.9 mg tablets USP Dissolution Test 6
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 4, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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