Recommended Topic Related To:

Elestrin

"The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mes"...

Elestrin

Elestrin

INDICATIONS

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

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. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see WARNINGS AND PRECAUTIONS].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

The gel is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm²).

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel (0.52 mg estradiol) per actuation (1 pump).

Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol).

Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.

HOW SUPPLIED

Dosage Forms And Strengths

Elestrin (estradiol gel) 0.06% is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 g of gel per pump actuation

Elestrin® (estradiol gel) 0.06% is a colorless, non-staining hydroalcoholic gel supplied in a non-aerosol, metered-dose pump container constructed of polypropylene. The drug product is contained within a collapsible inner liner/bag consisting of an inner and outer layer of low density polyethylene with a resealable polypropylene cap. Each pump container holds 35 g of gel and is capable of delivering 26 g of gel as 30 metered doses. Each metered dose delivers 0.87 g of gel which contains 0.52 mg of estradiol.

NDC 18860-480-01.. 35 g of pump container. This pump container is packaged individually or as two pump containers together in Cartons (18860-480-30 and 18860-480-60).
NDC
18860-480-30.....Carton containing one ELESTRIN 35 g pump container.
NDC 18860-480-60.....Carton containing two ELESTRIN 35 g pump containers.

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].

Distributed by: Meda Pharmaceuticals Commercial Corp., 1818 Market Street, Suite 2350, Philadelphia, PA 19103. Manufactured by: DPT Laboratories, Ltd. 318 McCullough San Antonio, TX 78215. Revised: Feb 2014

Last reviewed on RxList: 3/17/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations