April 23, 2017
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Menostar

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Menostar




Indications
Dosage
How Supplied

INDICATIONS

Prevention Of Postmenopausal Osteoporosis

Limitation Of Use

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

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. It is recommended that women who have a uterus and are treated with Menostar receive a progestin for 14 days every 6 to 12 months and undergo an endometrial biopsy at yearly intervals or as clinically indicated in order to detect any endometrial stimulation which might require further clinical action. A women without a uterus does not need a 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.

Prevention Of Postmenopausal Osteoporosis

Menostar 14 mcg per day applied to a clean dry area of the lower abdomen once weekly.

Application Of The Menostar Transdermal System

Site Selection
  • The adhesive side of Menostar should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.
  • Menostar should not be applied to or near the breasts.
  • The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a same site.
  • The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off. Application to areas where sitting would dislodge Menostar should also be avoided.
Application
  • Menostar should be applied immediately after opening the pouch and removing the protective liner.
  • Menostar should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
  • If the system lifts, apply pressure to maintain adhesion.
  • In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
  • Only one system should be worn at any one time during the 7-day dosing interval. Swimming, bathing, or using a sauna while using Menostar has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

Removal Of The Menostar Transdermal System

  • Removal of the system should be done carefully and slowly to avoid irritation of the skin.
  • Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
    Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it awa

HOW SUPPLIED

Dosage Forms And Strengths

Menostar (estradiol transdermal system) 14 mcg per day - each 3.25 cm² system contains 1 mg of estradiol.

Menostar (estradiol transdermal system), 14 mcg per day - each 3.25 cm system contains 1 mg of estradiol USP

Individual Carton of 4 systems NDC 50419-455-04

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F°F and 86°F).

Do not store above 86°F (30°C).

Do not store unpouched. Apply immediately upon removal from the protective pouch.

Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

Manufactured by 3M Drug Delivery Systems, Northridge, CA 91324. Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. Revised: Jul 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/28/2016

Indications
Dosage
How Supplied

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.


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