DELESTROGEN- estradiol valerate injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL - UNII:4TI98Z838E)

Tillgänglig från:

Par Pharmaceutical, Inc.

INN (International namn):

ESTRADIOL VALERATE

Sammansättning:

ESTRADIOL VALERATE 10 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). DELESTROGEN should not be used in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Liver dysfunction or disease. 7. DELESTROGEN should not be used in patients with known hypersensitivity to its ingredients. 8. Known or suspected pregnancy. There is no indication for DELESTROGEN in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy [see PRECAUTIONS ].

Produktsammanfattning:

DELESTROGEN® (estradiol valerate injection, USP) Multiple Dose Vials 10 mg/mL (5 mL): NDC 42023-110-01 20 mg/mL (5 mL): NDC 42023-111-01 40 mg/mL (5 mL): NDC 42023-112-01 Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Keep out of reach of children.

Bemyndigande status:

New Drug Application

Produktens egenskaper

DELESTROGEN- ESTRADIOL VALERATE INJECTION
PAR PHARMACEUTICAL, INC.
----------
DELESTROGEN
(ESTRADIOL VALERATE INJECTION, USP)
RX ONLY
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 [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 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 or to
women
taking estrogen alone therapy [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 risks, estrogens
with or without
progestins should be