ESTRADIOL patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ESTRADIOL

Composition:

ESTRADIOL 0.97 mg in 48 [USP'U]

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Transdermal System Continuous Delivery (Once-Weekly), USP is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause.  - 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. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - 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 elementa

Product summary:

Estradiol Transdermal System, 0.025 mg/day Continuous Delivery (Once-Weekly), USP – each 7.75 cm2 system contains 0.97 mg of estradiol USP NDC 54868-5009-0     Individual Carton of 4 systems NDC 54868-4811-0     Individual Carton of 4 systems NDC 54868-4813-0     Individual Carton of 4 systems Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Do not store unpouched. Apply immediately upon removal from the protective pouch. MYLAN PHARMACEUTICALS INC. Morgantown, WV 26505 REVISED AUGUST 2008 ETS:R16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL - ESTRADIOL PATCH
PHYSICIANS TOTAL CARE, INC.
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PRESCRIBING INFORMATION Estradiol Transdermal System Continuous
Delivery (Once-
Weekly), USP
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 of 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 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 estrogens (CE
0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
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 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 and 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
tria