ANGELIQ- drospirenone and estradiol tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ANGELIQ is indicated in women who have a uterus for the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Progestogens/estrogens should not be used in individuals with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Renal insufficiency. 7. Liver dysfunction or disease. 8. Adrenal insufficiency. 9. ANGELIQ should not be used in patients with known hypersensitivity to its ingredients. 10. Known or suspec

Product summary:

ANGELIQ TABLETS (drospirenone and estradiol) 0.5 mg/1 mg are available as round, biconvex pink film-coated tablets embossed with "CK" inside a hexagon, and supplied in the following packaging: 1 blisters of 28 tablets NDC 54868-6184-0 Storage Conditions Store at 25° C (77° F); excursions permitted to 15– 30° C (59– 86° F) [See USP Controlled Room Temperature]. REFERENCES FURNISHED UPON REQUEST

Authorization status:

New Drug Application

Summary of Product characteristics

ANGELIQ - DROSPIRENONE AND ESTRADIOL TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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ANGELIQ TABLETS
(DROSPIRENONE AND ESTRADIOL)
0.5 MG/1 MG
RX ONLY
PRESCRIBING INFORMATION
BOXED WARNINGS
Estrogens with or without progestins should not be used for the
prevention of cardiovascular
disease or dementia. (See WARNINGS, Cardiovascular disorders and
Dementia.) The Women's
Health Initiative (WHI) study 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 years of treatment with oral conjugated equine
estrogens (CE 0.625mg)
combined with medroxyprogesterone acetate (MPA 2.5mg) relative to
placebo (see CLINICAL
PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders
and Malignant
neoplasms, Breast cancer.) The Women's Health Initiative Memory Study
(WHIMS), a substudy of
WHI, reported increased risk of developing probable dementia in
postmenopausal women 65
years of age or older during 5.2 years of treatment with conjugated
estrogens alone and during 4
years of treatment with oral conjugated estrogens plus
medroxyprogesterone acetate, relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women. (See
CLINICAL PHARMACOLOGY, 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.
Because of these risks, estrogens with or without progestins should be
prescribed at the lowest
effective doses and for the shortest duration consistent with
treatment goals and risks for the
individual woman.
DES CRIPTION
ANGELIQ TABLETS provide a hormone regimen consisting of film coated
tablets each containing 0.5
mg of drospirenone and 1 mg of estradiol. The inactive ingredie