MENOSTAR Patch Ref.[50375] Active ingredients: Estradiol

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally a woman without a uterus does not need to take a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestogen [see Warnings and Precautions (5.2, 5.14)].

Use estrogen-alone, or in combination with a progestogen at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Prevention of Postmenopausal Osteoporosis

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

2.2 Application of the Menostar Transdermal System

Site Selection:

• Place the adhesive side of Menostar on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.
• Do not apply Menostar to or near the breasts.
• Rotate the sites of application with an interval of at least 1-week allowed between applications to a same site.
• Select an area that is not oily, damaged, or irritated. Avoid the waistline, since tight clothing may rub the transdermal system off.
• Avoid application to areas where sitting would dislodge Menostar.

Application:

• Apply Menostar immediately after opening the pouch and removing the protective liner.
• Press Menostar 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 falls off, reapply it to a different location. If the old system cannot be reapplied, apply a new system for the remainder of the 7-day dosing interval.
• Wear only one system 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:

• Remove Menostar carefully and slowly to avoid irritation of the skin.
• If any adhesive remains on the skin after removal of Menostar, allow the area to dry for 15 minutes and then gently rub the area with an oil-based cream or lotion to remove the adhesive residue.
• Used patches still contain some active hormones. Carefully fold each patch in half so that it sticks to itself before throwing it away.

Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation of Menostar therapy with institution of appropriate symptomatic care.

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