PREMARIN Vaginal cream (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Λέξεις κλειδιά

0046-0872

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1. Indications and Usage

1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae 1.2 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

2. Dosage and Administration

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a ...

3. Dosage Forms and Strengths

Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of ...

4. Contraindications

PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions: Undiagnosed abnormal genital bleeding Known, suspected, or history of breast cancer Known or suspected estrogen-dependent ...

5. Warnings and Precautions

5.1 Risks from Systemic Absorption Systemic absorption occurs with the use of PREMARIN Vaginal Cream. The warnings, precautions, and adverse reactions associated with oral PREMARIN treatment should be ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2)] Malignant Neoplasms [see Boxed ...

6.1. Clinical Trials Experience

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

6.2. Postmarketing Experience

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

7. Drug Interactions

No drug interaction studies have been conducted for PREMARIN Vaginal Cream. 7.1 Metabolic Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially ...

8.1. Pregnancy

PREMARIN Vaginal Cream 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 ...

8.3. Nursing Mothers

PREMARIN Vaginal Cream 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 ...

8.4. Pediatric Use

PREMARIN Vaginal Cream is not indicated in children. Clinical studies have not been conducted in the pediatric population.

8.5. Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMARIN Vaginal Cream to determine whether those over 65 years of age differ from younger subjects in their ...

8.6. Renal Impairment

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

8.7. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of PREMARIN Vaginal Cream 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

Each gram of PREMARIN (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, ...

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

Currently, there are no pharmacodynamic data known for PREMARIN Vaginal Cream.

12.3. Pharmacokinetics

Absorption Conjugated estrogens are water soluble and are well-absorbed through the skin, mucous membranes, and the gastrointestinal (GI) tract. The vaginal delivery of estrogens circumvents first-pass ...

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 Vulvar and Vaginal Atrophy A 12-week, prospective, randomized, double-blind placebo-controlled study was conducted to compare the safety and efficacy of 2 PREMARIN Vaginal Cream (PVC) regimens ...

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) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. of 1.06 oz (30 g) tube with plastic applicator(s) ...

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].

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use). 17.1 Vaginal Bleeding Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider ...

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 ...