DEPO-ESTRADIOL- estradiol cypionate injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ESTRADIOL CYPIONATE (UNII: 7E1DV054LO) (ESTRADIOL - UNII:4TI98Z838E)

Dostupné s:

Pharmacia & Upjohn Company LLC

INN (Mezinárodní Name):

ESTRADIOL CYPIONATE

Složení:

ESTRADIOL CYPIONATE 5 mg in 1 mL

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

DEPO-Estradiol Injection is indicated in the treatment of: Estrogens should not be used in individuals with any of the following conditions: 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.) Chlorobutanol anhydrous (chloral derivative) added as a preservative may be habit forming.

Přehled produktů:

DEPO-Estradiol Injection is available in the following concentration containing per mL: 5 mg estradiol cypionate; also 5.4 mg chlorobutanol anhydrous (chloral deriv.) added as preservative; in 913 mg cottonseed oil— in 5 mL vials, NDC 0009-0271-01. WARNING: Chlorobutanol may be habit forming. Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DEPO-ESTRADIOL- ESTRADIOL CYPIONATE INJECTION
PHARMACIA & UPJOHN COMPANY LLC
----------
DEPO -ESTRADIOL
ESTRADIOL CYPIONATE INJECTION, USP
WARNINGS
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 currently 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 with and without 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 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 o