PREMARIN Powder for solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Λέξεις κλειδιά

0046-0749

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BOXED WARNING SECTION

<b>WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA</b> Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with ...

1. 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 ...

2. 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 dynamic ...

3. 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 Intravenous ...

4. 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. Known or suspected ...

5. Warnings

See BOXED WARNINGS. Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into ...

6.1. General

Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into account. 1. Addition ...

6.2. Information for Patients

Physicians are advised to discuss the contents of the PATIENT INFORMATION leaflet with patients who are being treated with Premarin Intravenous.

6.3. Laboratory Tests

Estrogen administration should be guided by clinical response at the lowest dose, rather than laboratory monitoring.

6.5. Drug/Laboratory Test Interactions

Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

(See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.) Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, ...

6.7. Pregnancy

Premarin Intravenous should not be used during pregnancy. (See CONTRAINDICATIONS.)

6.9. Nursing Mothers

Premarin Intravenous should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens ...

6.10. Pediatric Use

Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established. Large and ...

6.11. Geriatric Use

There have not been sufficient numbers of geriatric patients involved in studies utilizing Premarin to determine whether those over 65 years of age differ from younger subjects in their response to Premarin. ...

7. Adverse Reactions

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

9. 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 ...

10. 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 since more ...

11. How Supplied

NDC 0046-0749-05–Each package provides one SECULE vial containing 25 mg of conjugated estrogens, USP, for injection (also lactose 200 mg, sodium citrate 12.2 mg, and simethicone 0.2 mg). The pH is adjusted ...

12. Storage and Handling

Directions for Storage and Reconstitution Storage Before Reconstitution Store package in refrigerator, 2° to 8°C (36° to 46°F). To Reconstitute Reconstitute Premarin Intravenous with 5 mL of Sterile Water ...

13. Clinical Studies

Womens Health Initiative Studies The Womens Health Initiative (WHI) enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily ...