PREMARIN- conjugated estrogens injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX)

Available from:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

ESTROGENS, CONJUGATED

Composition:

ESTROGENS, CONJUGATED 25 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology. Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels. Premarin Intravenous therapy should not be used in individuals with any of the following conditions:

Product summary:

NDC 0046-0749-05–Each package provides one single-dose vial containing 25 mg/vial of conjugated estrogens, USP, for injection (also lactose 200 mg, sodium citrate 12.2 mg, and simethicone 0.2 mg). The pH is adjusted with sodium hydroxide or hydrochloric acid. Premarin Intravenous (conjugated estrogens, USP) for injection is prepared by cryodesiccation.

Authorization status:

New Drug Application

Summary of Product characteristics

PREMARIN- CONJUGATED ESTROGENS INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
----------
PREMARIN
INTRAVENOUS
(CONJUGATED ESTROGENS, USP) FOR INJECTION
SPECIALLY PREPARED FOR INTRAVENOUS & INTRAMUSCULAR USE
RX ONLY
®
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS,
BREAST CANCER AND PROBABLE DEMENTIA
ESTROGEN-ALONE THERAPY
ENDOMETRIAL CANCER
There is an increased risk of endometrial cancer in a woman with a
uterus who
uses unopposed estrogens. Adding a progestin to estrogen therapy has
been
shown to reduce the risk of endometrial hyperplasia, which may be a
precursor to
endometrial cancer. Adequate diagnostic measures, including directed
or random
endometrial sampling when indicated, should be undertaken to rule out
malignancy
in postmenopausal women with undiagnosed persistent or recurring
abnormal
genital bleeding. (See WARNINGS, MALIGNANT NEOPLASMS, ENDOMETRIAL
CANCER.)
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen-alone therapy should not be used for the prevention of
cardiovascular
disease or dementia. (See CLINICAL STUDIES and WARNINGS,
CARDIOVASCULAR
DISORDERS and PROBABLE DEMENTIA.)
The Women's Health Initiative (WHI) estrogen-alone substudy reported
increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women
(50 to
79 years of age) during 7.1 years of treatment with daily oral
conjugated estrogens
(CE) [0.625 mg]-alone, relative to placebo. (See CLINICAL STUDIES and
WARNINGS, CARDIOVASCULAR DISORDERS.)
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI
reported an increased risk of developing probable dementia in
postmenopausal
women 65 years of age or older during 5.2 years of treatment with
daily CE (0.625
mg)-alone, relative to placebo. It is unknown whether this finding
applies to
younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS,
PROBABLE DEMENTIA and PRECAUTIONS, GERIATRIC USE.)
In the absence of comparable data, these risks should be assumed to be
similar for
other doses of