ESTROGEL Gel (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

ASCEND Therapeutics US, LLC

Λέξεις κλειδιά

17139-617

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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 ...

1. Indications and Usage

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

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 progestin. ...

3. Dosage Forms and Strengths

EstroGel 0.06% is an estradiol transdermal gel. One pump depression delivers 1.25 g of gel that contains 0.75 mg estradiol.

4. Contraindications

EstroGel is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding Known, suspected, or history of breast cancer Known or suspected estrogen-dependent neoplasia ...

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 the labeling: Cardiovascular Disorders [see Boxed Warning, and Warnings and Precautions (5.1)] 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 trials 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 EstroGel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted for EstroGel. 7.1 Metabolic Interactions In vitro and in vivo studies have shown that estrogens are metabolized ...

8.1. Pregnancy

EstroGel 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

EstroGel 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 estrogen have been identified ...

8.4. Pediatric Use

EstroGel 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 studies utilizing EstroGel to determine whether those over 65 years of age differ from younger subjects in their response to EstroGel. ...

8.6. Renal Impairment

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

8.7. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of EstroGel 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

EstroGel (estradiol gel) contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression ...

12. Clinical Pharmacology

EstroGel provides systemic estrogen therapy by releasing estradiol, the major estrogenic hormone secreted by the human ovary.

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 EstroGel.

12.3. Pharmacokinetics

Absorption Estradiol is transported across intact skin and into the systemic circulation by a passive diffusion process. The rate of diffusion across the stratum corneum is the rate-limiting factor. When ...

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 a placebo-controlled study, 145 postmenopausal women between 29 and 67 years of age (81.4 percent were White) were randomly assigned to receive 1.25 g of EstroGel ...

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

EstroGel is a clear, colorless, hydroalcoholic 0.06 percent estradiol gel supplied in a non‑aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable ...

16.2. Storage and Handling

Keep out of reach of children. 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 ...