PREMARIN Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Λέξεις κλειδιά

0046-1100 0046-1101 0046-1102 0046-1103 0046-1104

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1. Indications and Usage

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use: When prescribing ...

2. Dosage and Administration

Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer [see Boxed Warning]. A woman ...

3. Dosage Forms and Strengths

PREMARIN (conjugated estrogens tablets, USP): Tablet Strength Tablet Shape/Color Imprint 0.3 mg oval/green PREMARIN 0.3 0.45 mg oval/blue PREMARIN 0.45 0.625 mg oval/maroon PREMARIN ...

4. Contraindications

PREMARIN therapy is contraindicated in individuals with any of the following conditions: Undiagnosed abnormal genital bleeding Known, suspected, or history of breast cancer except in appropriately selected ...

5. Warnings and Precautions

5.1 Cardiovascular Disorders An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)] Malignant Neoplasms [see Boxed Warning, ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of PREMARIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible ...

7. Drug Interactions

Data from a single-dose drug-drug interaction study involving conjugated estrogens and medroxyprogesterone acetate indicate that the pharmacokinetic disposition of both drugs is not altered when the drugs ...

8.1. Pregnancy

PREMARIN should not be used during pregnancy [see Contraindications (4)]. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and ...

8.3. Nursing Mothers

PREMARIN 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 have been ...

8.4. 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 ...

8.5. 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. ...

8.6. Renal Impairment

The effect of renal impairment on the pharmacokinetics of PREMARIN has not been studied.

8.7. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of PREMARIN has not been studied.

10. 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 ...

11. Description

PREMARIN (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens purified from pregnant mares' urine and consists of the sodium salts of water-soluble estrogen ...

12.1. Mechanism of Action

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 ...

12.2. Pharmacodynamics

There are no pharmacodynamic data for PREMARIN.

12.3. Pharmacokinetics

Absorption Conjugated estrogens are water-soluble and are absorbed from the gastrointestinal tract after release from the drug formulation. The PREMARIN tablet releases conjugated estrogens slowly over ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

14. Clinical Studies

14.1 Effects on Vasomotor Symptoms In the first year of the Health and Osteoporosis, Progestin and Estrogen (HOPE) Study, a total of 2,805 postmenopausal women (average age 53.3 ± 4.9 years) were randomly ...

15. References

Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007;297:1465–1477. Hsia J, et al. Conjugated Equine Estrogens and ...

16.1. How Supplied

PREMARIN (conjugated estrogens tablets, USP) Each oval green tablet contains 0.3 mg, in bottles of 100 (NDC 0046-1100-81) and 1,000 (NDC 0046-1100-91). Each oval blue tablet contains 0.45 mg, in bottles ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP.

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information). 17.1 Vaginal Bleeding Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible ...

BOXED WARNING SECTION

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial ...