PREMARIN- conjugated estrogens tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX)

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, Inc.

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.625 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PREMARIN therapy is indicated in the: - Treatment of moderate to severe vasomotor symptoms due to menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - 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 in

Produkt oppsummering:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. PREMARIN® (conjugated estrogens tablets, USP) — Each oval green tablet contains 0.3 mg, in bottles of 100 (NDC 0046-1100-81) and 1,000 (NDC 0046-1100-91). — Each oval blue tablet contains 0.45 mg, in bottles of 100 (NDC 0046-1101-81). — Each oval maroon tablet contains 0.625 mg, in bottles of 100 (NDC 0046-1102-81) and 1,000 (NDC 0046-1102-91). — Each oval white tablet contains 0.9 mg, in bottles of 100 (NDC 0046-1103-81). — Each oval yellow tablet contains 1.25 mg, in bottles of 100 (NDC 0046-1104-81) and 1,000 (NDC 0046-1104-91). The appearance of these tablets is a trademark of Wyeth LLC. 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]. Dispense in a well-closed container, as defined in the USP. LAB-0467-3.0 Rev 10/2011

Autorisasjon status:

New Drug Application

Preparatomtale

PREMARIN- CONJUGATED ESTROGENS TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
PREMARIN
(CONJUGATED ESTROGENS TABLETS, USP)
RX ONLY
®
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER AND PROBABLE DEMENTIA
ESTROGEN-ALONE THERAPY
ENDOMETRIAL CANCER
There is an increased risk of endometrial cancer in a woman with a
uterus who uses unopposed
estrogens. Adding a progestin to estrogen therapy has been shown to
reduce the risk of
endometrial hyperplasia, which may be a precursor to endometrial
cancer. Adequate diagnostic
measures, including directed or random endometrial sampling when
indicated, should be
undertaken to rule out malignancy in postmenopausal women with
undiagnosed persistent or
recurring abnormal genital bleeding. (See WARNINGS, MALIGNANT
NEOPLASMS, ENDOMETRIAL
CANCER.)
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or
dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS
and
PROBABLE DEMENTIA.)
The Women's Health Initiative (WHI) estrogen-alone substudy reported
increased risks of stroke
and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years
of age) during 7.1
years of treatment with daily oral conjugated estrogens (CE) [0.625
mg]-alone, relative to
placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR
DISORDERS.)
The WHI Memory Study (WHIMS) estrogen-alone ancillary study 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 daily CE (0.625 mg)-alone,
relative to placebo. It is
unknown whether this finding applies to younger postmenopausal women.
(See CLINICAL
STUDIES and WARNINGS, PROBABLE DEMENTIA and PRECAUTIONS, GERIATRIC
USE.)
In the absence of comparable data, these risks should be assumed to be
similar for other doses of
CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the
lowes