ESTRA-50- estradiol pellet pellet, implantable ESTRA-25- estradiol pellet pellet, implantable

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Advanced Pharmaceutical Technology, Inc.

INN (שם בינלאומי):

ESTRADIOL

הרכב:

ESTRADIOL 50 mg

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Estradiol is indicated in the treatment of: 1. Estrogen deficiency in Hysterectomized Women. (There is no evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause, and they should not be used to treat these conditions.) 2. Atrophic vaginitis. 3. Kraurosis vulvae. 4. Female hypogonadism. 5. Female castration. 6. Primary ovarian failure. 7. Breast cancer (for palliation only) in approximately selected women and men with metastatic disease. 8. Postpartum breast engorgement- Althoughestrogens have been widely used for the prevention of postpatum breast engorgement, controlled studies hve demonstrated that the incidence of significapainful engorgementin patients not receiving such hormonal therapy is low and usually responsive to appropriate analgesic or other supportive therapy. Consequently, the benefit to be derived from estrogen therapy for this indication must be carefully weighed against the potential increased risk or puerperal thromboembolism associated with the use of large doses of estrogen. 20,22 ESTRADIOL HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURIG PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING). Estrogens should not be used in women (or men) with any of the following conditions: 1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2. Known or suspected estrogen-dependant neoplasia. 3. Known or suspected pregnancy (See Boxed Warning). 4. Undiagnosed abnormal genital bleeding. 5. Active thrombophlebitis or thromboembolic disorders. 6. Apast history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast prostatic malignancy).

מצב אישור:

Export only

מאפייני מוצר

ESTRA-50- ESTRADIOL PELLET PELLET, IMPLANTABLE
ESTRA-25- ESTRADIOL PELLET PELLET, IMPLANTABLE
ADVANCED PHARMACEUTICAL TECHNOLOGY, INC.
----------
ESTRA-50 & ESTRA-25
WARNING
1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL
CARCINOMA.
Three independent case control studies have shown an increased risk od
endometrial cancer in postmenopausal women exposed to exogenous
estrogens
for prolonged periods.
The risk was independent of other known risk factors for
endometrial cancer. These studies are further supported by the finding
that
incidence rates of endometrial cancer have increased sharply since
1969 in eight
different areas of the United States with population-based cancer
reporting
systems, an increase which may be related to rapidly expanding use of
estrogens
during the last decade.
The three case control studies reported that the riskof endometrial
cancer in
estrogen users was about 4.5 to 13.9 times greater than in nonusers.
The rik
appears to depend on both duration of treatment
and on estrogen dose.
In
view of these findings, when estrogens are used for the treatment of
menopausalsymptoms, the lowest dose that will controlsymptoms should
be
utilized and medication should be discontinuedas soon as possible.
When
prolonged treatment is medically indicated, the patient should be
reassessedon at
least a semiannual basis to determine the need for continued therapy.
Although the evidence must be considered preliminary, one study
suggests that
cyclic administration in low doses of estrogen may carry less risk
than continuos
administration,
it therefore appears prudent to utilize such a regimen.
Close clinical surveillance of all women taking estrogens is
important. In all cases of
undiagnosed persistant or recurring abnormal vaginal bleeding,
adequate
diagnostic measures should be undertaken to rule out malignancy.
There is no evidence at present that "natural" estrogens are more or
less
hazardous than "synthetic" estrogens at equiestrogenic doses.
2. ESTROGENS SHOULD NOT BE USED DURING PREGNANC