PREMARIN® INTRAVENOUS Principal Display Panel (conjugated estrogens) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 25 mg Vial Label

SECULE® vial

Refrigerate at 2° to 8°C (36° to 46°F).

NDC 0046-0749-05
Rx only

Pfizer

Premarin® Intravenous
(conjugated estrogens, USP) for injection
Prepared by cryodesiccation.

25 mg

To be reconstituted with Sterile Water for Injection, USP.
See package circular for reconstitution
instructions and complete directions for use.
Distributed by Wyeth Pharmaceuticals LLC
A subsidiary of Pfizer Inc

14513801
cod. 224591

PRINCIPAL DISPLAY PANEL - 25 mg Vial Label

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton

Pfizer
NDC 0046-0749-05
Rx only

Premarin® Intravenous
(conjugated estrogens,
USP) for injection

25 mg

Prepared by cryodesiccation.

This package provides one
SECULE® vial containing 25 mg
of conjugated estrogens, USP,
for injection.

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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Resources

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WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial...

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INDICATIONS AND USAGE

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...

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DOSAGE AND ADMINISTRATION

For treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology:

One 25 mg injection, intravenously or intramuscularly. Intravenous use is preferred...

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CONTRAINDICATIONS

Premarin Intravenous therapy should not be used in individuals with any of the following conditions:

Undiagnosed abnormal genital bleeding.
Known, suspected, or history of breast cancer...

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WARNINGS

See BOXED WARNINGS.

Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral...

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ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

...

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OVERDOSAGE

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of...

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DESCRIPTION

Premarin Intravenous (conjugated estrogens, USP) for injection contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates...

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CLINICAL PHARMACOLOGY

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a...

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CLINICAL STUDIES

Women's Health Initiative Studies

The Women's Health Initiative (WHI) enrolled approximately 27,000 predominantly healthy postmenopausal women in two...

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HOW SUPPLIED

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...

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PATIENT INFORMATION

Premarin Intravenous (conjugated estrogens, USP) for injection

Read this PATIENT INFORMATION which describes the benefit and major risks of your treatment, as well as how...

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Specially prepared for Intravenous & Intramuscular use

Rx only

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Resources

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Premarin Website for Healthcare Professionals

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Premarin Website for Consumers and Patients

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.