CENESTIN- synthetic conjugated estrogens, a tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED SYNTHETIC A (UNII: JM2621P2LS) (ESTROGENS, CONJUGATED SYNTHETIC A - UNII:JM2621P2LS)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

ESTROGENS, CONJUGATED SYNTHETIC A

Sammensetning:

ESTROGENS, CONJUGATED SYNTHETIC A 0.45 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Cenestin therapy is indicated for the: 1. Treatment of moderate-to-severe vasomotor symptoms associated with the menopause. - 0.45 mg Cenestin - 0.625 mg Cenestin - 0.9 mg Cenestin - 1.25 mg Cenestin 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. - 0.3 mg Cenestin Cenestin 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 a 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. - Cenestin therapy should not be used in patients with known hypersensitivity to its ingredients. - Known or su

Produkt oppsummering:

Cenestin (synthetic conjugated estrogens, A) Tablets are available as: Round, orange, film-coated, and are debossed with letters, dp , and number, 46. Round, red, film-coated, and are debossed with letters, dp , and number, 42. Round, blue, film-coated, and are debossed with letters, dp , and number, 44. Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Dispense in tight container. Dispense in child-resistant packaging. Keep out of the reach of children. Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.

Autorisasjon status:

New Drug Application

Preparatomtale

CENESTIN - SYNTHETIC CONJUGATED ESTROGENS, A TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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CENESTIN
(SYNTHETIC CONJUGATED ESTROGENS, A) TABLETS
RX ONLY
REVISED SEPTEMBER 2004
11000422506
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 and without progestins should not be used for the
prevention of cardiovascular
disease. (See WARNINGS, CARDIOVASCULAR DISORDERS.)
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 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo.
(See CLINICAL PHARMACOLOGY, CLINICAL STUDIES.)
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 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.)
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 ris