DIVIGEL- estradiol gel

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

ESTRADIOL

Склад:

ESTRADIOL 1.0 mg in 1 g

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Divigel® (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause. Estrogen products, including Divigel® (estradiol gel) 0.1%, should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism, or history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Known hypersensitivity to the ingredients of Divigel® . - Known or suspected pregnancy. There is no indication for Divigel® in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS .)

Огляд продуктів:

Divigel® (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0 , carton of 30 packets, 1.0 mg estradiol per single-dose foil packet Keep out of the reach of children. Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Manufactured by Orion Corporation Orion Pharma Tengströminkatu 8 FI-20360 Turku Finland Distributed by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007 Relabeling of "Additional Barcode" by Physicians Total Care, Inc. Tulsa, OK      74146

Статус Авторизація:

New Drug Application

Характеристики продукта

DIVIGEL - ESTRADIOL GEL
PHYSICIANS TOTAL CARE, INC.
----------
DIVIGEL
(ESTRADIOL GEL) 0.1%
RX ONLY
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is
important. Adequate diagnostic
measures, including endometrial sampling when indicated, should be
undertaken to rule out
malignancy in all cases of undiagnosed persistent or recurring
abnormal vaginal bleeding. There
is no evidence that the use of "natural" estrogens results in a
different endometrial risk profile
than synthetic estrogens at equivalent estrogen doses. (See WARNINGS,
MALIGNANT NEOPLASMS,
ENDOMETRIAL CANCER.)
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-alone substudy of the Women's Health Initiative (WHI)
reported increased risks of
stroke and deep vein thrombosis 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)
alone per day, relative to placebo. (See CLINICAL STUDIES and
WARNINGS,
CARDIOVASCULAR DISORDERS.)
The estrogen-plus-progestin substudy of the WHI reported increased
risk 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 Women's Health Initiative Memory Study (WHIMS), a substudy of the
WHI, reported an
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older during 5.2 years of treatment with CE 0.625 mg alone and during
4 years of treatment with
CE 0.625 mg combined with MPA 2.5 mg, relative to pl