ESTRADIOL / NORETHINDRONE ACETATE- estradiol and norethindrone acetate tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Estradiol (UNII: 4TI98Z838E) (Estradiol - UNII:4TI98Z838E), Norethindrone Acetate (UNII: 9S44LIC7OJ) (Norethindrone - UNII:T18F433X4S)

Mevcut itibaren:

Physicians Total Care, Inc.

INN (International Adı):

Estradiol

Kompozisyon:

Estradiol 1 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 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. Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg is also in

Ürün özeti:

Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg are white, convex, coated tablets debossed with "B" on one side and "474" on the other side (NDC 54868-4677-0). Estradiol/Norethindrone Acetate Tablets are supplied as:    28 tablets in a calendar blister pack dispenser. Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ESTRADIOL / NORETHINDRONE ACETATE - ESTRADIOL AND NORETHINDRONE
ACETATE TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
ESTRADIOL/NORETHINDRONE ACETATE TABLETS
1.0 mg/0.5 mg
0.5 mg/0.1 mg
RX ONLY
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the
prevention of cardiovascular
disease or dementia. (See CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR DISORDERS
and DEMENTIA.)
The estrogen plus progestin substudy of the Women's Health Initiative
(WHI) reported increased
risks of myocardial infarction, stroke, invasive breast cancer,
pulmonary emboli, and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 5.6
years of treatment with
oral conjugated estrogens (CE 0.625 mg) combined with
medroxyprogesterone acetate (MPA 2.5
mg) per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR
DISORDERS and MALIGNANT NEOPLASMS, BREAST CANCER.)
The estrogen-alone substudy of the WHI reported increased risks of
stroke and deep vein
thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 6.8 years and 7.1
years, respectively, of treatment with oral conjugated estrogens (CE
0.625 mg) per day, relative
to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR
DISORDERS.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of the
WHI study, reported
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older during 4 years of treatment with CE 0.625 mg combined with MPA
2.5 mg and during 5.2
years of treatment with CE 0.625 mg alone, relative to placebo. It is
unknown whether this finding
applies to younger postmenopausal women. (See CLINICAL STUDIES,
WARNINGS,
DEMENTIA and PRECAUTIONS, GERIATRIC USE.)
Other doses of oral conjugated estrogens with medroxyprogesterone
acetate, and other
combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical
trials and, in the absence of comparable data, these risks should be
assumed to be similar.