ESTRADERM- estradiol patch, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E)

Διαθέσιμο από:

Novartis Pharmaceuticals Corporation

INN (Διεθνής Όνομα):

estradiol

Φαρμακοτεχνική μορφή:

PATCH, EXTENDED RELEASE

Σύνθεση:

4 mg

Οδός χορήγησης:

TRANSDERMAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Estraderm® (estradiol transdermal system) is indicated in: - 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 elemental calcium. Therefore, when not contraindic

Περίληψη προϊόντος:

Estraderm estradiol transdermal system 0.05 mg/day – each 10 cm2 system contains 4 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day. Patient Calendar Pack of 8 Systems………………………………………NDC0083-2310-08 Carton of 6 Patient Calendar Packs of 8 Systems………...……………..NDC 0083-2310-62 Estraderm estradiol transdermal system 0.1 mg/day – each 20 cm2 system contains 8 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day. Patient Calendar Pack of 8 Systems……………………………………...NDC 0083-2320-08 Carton of 6 Patient Calendar Packs of 8 Systems……..………………...NDC 0083-2320-62 *See DESCRIPTION. Do not store above 30°C (86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch. REV: JANUARY 2005                        T2005-11

Αρχείο Π.Χ.Π.

ESTRADERM- ESTRADIOL PATCH, EXTENDED RELEASE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
ES TRADERM
T2005-11/T2005-12 ESTRADERM (ESTRADIOL TRANSDERMAL SYSTEM) CONTINUOUS DELIVERY FOR TWICE-WEEKLY APPLICATION RX ONLY
PRESCRIBING INFORMATION
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 and 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).
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 shou