RVP

Drug Catalog - Product Detail

ESTRADIOL/NORETHINDRONE ACETATE TB 1/.05MG 1X28

NDC Mfr Size Str Form
51991-0474-28 BRECKENRIDGE 28 1-0.5MG TABLET
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PACKAGE FILES

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Generic Name
ESTRADIOL AND NORETHINDRONE ACETATE
Substance Name
ESTRADIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078324
Description
11 DESCRIPTION Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose and triacetin. Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose and triacetin. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C 18 H 24 O 2 , ½ H 2 O and a molecular weight of 281.4. The structural formula of E 2 is as follows: Estradiol Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C 22 H 28 O 3 and molecular weight of 340.5. The structural formula of NETA is as follows: Norethindrone Acetate Chemical Structure Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg are available as white, convex, coated tablets debossed with "B" on one side and "474" on the other side. (NDC 51991-474-28). It is supplied as 28 tablets in a calendar blister pack dispenser. Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg are available as white, convex, coated tablets debossed with "B" on one side and "623" on the other side. (NDC 51991-623-28). It is supplied as 28 tablets in a calendar blister pack dispenser. 16.2 Storage and Handling Store in a dry place protected from light. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Estradiol/Norethindrone Acetate Tablets are indicated for: Estradiol/Norethindrone Acetate Tablets are an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use : When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis ( 1.3 ) Limitations of Use : When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of 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 Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. 1.3 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Take a single Estradiol/Norethindrone Acetate 1 mg/0.5 mg or 0.5 mg/0.1 mg tablet orally once daily for the Treatment of Moderate to severe Vasomotor Symptoms due to Menopause and for the Prevention of Postmenopausal Osteoporosis ( 2.1 , 2.3 ) Estradiol/Norethindrone Acetate 1 mg/0.5 mg tablets are taken orally once daily for the Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 2.2 ) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Take a single Estradiol/Norethindrone Acetate tablet orally once daily for the treatment of moderate to severe vasomotor symptoms due to menopause. Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Take a single Estradiol/Norethindrone Acetate tablet orally once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg 2.3 Prevention of Postmenopausal Osteoporosis Take a single Estradiol/Norethindrone Acetate tablet orally once daily for the prevention of postmenopausal osteoporosis. Estradiol/Norethindrone Acetate Tablets 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg