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Climara Pro

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Climara Pro

Climara Pro

INDICATIONS

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

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

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 women. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine if treatment is still necessary.

One Climara Pro transdermal system is available for use.

Initiation of Therapy

Women not currently using continuous estrogen-alone therapy or estrogen plus progestin therapy may start therapy with Climara Pro at any time. However, women currently using continuous estrogen-alone therapy or estrogen plus progestin therapy should complete the current cycle of therapy before initiating Climara Pro therapy. Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin Climara Pro therapy.

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Climara Pro 0.045 mg per day/0.015 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to discontinue the medication should be made at 3 to 6 month intervals.

Prevention of Postmenopausal Osteoporosis

Climara Pro 0.045 mg per day/0.015 mg per day applied to the skin once weekly.

Application of the Transdermal System

Site Selection
  • The adhesive side of Climara Pro should be placed on a smooth (fold free), clean, dry area of the skin on the lower abdomen or the upper quadrant of the buttock.
  • Climara Pro should not be applied to or near the breasts.
  • The area selected should not be oily (which can impair adherence of the system), damaged, or irritated.
  • The waistline should be avoided, since tight clothing may rub Climara Pro off or modify drug delivery.
  • Application to areas where sitting would dislodge Climara Pro should also be avoided.
  • The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site.
Application
  • Climara Pro should be applied immediately after opening the pouch and removing the protective lining.
  • Climara Pro 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, the same system may be reapplied to another area of the lower abdomen. If the system cannot be reapplied, a new system may be applied, in which case, the original treatment schedule should be continued.
  • Only one system should be worn at any one time during 7-day dosing interval.
  • Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.
  • Swimming, bathing, or using a sauna while using Climara Pro has not been studied, and these activities may decrease the adhesion of the system and the delivery of the estrogen and progestin.

Removal of the Transdermal System

  • Removal of Climara Pro 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 away.

HOW SUPPLIED

Dosage Forms And Strengths

Climara Pro (estradiol/levonorgestrel transdermal system) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm² system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel.

Individual Carton of 4 systems

Climara Pro (estradiol/levonorgestrel transdermal system) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm² system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel. NDC 50419-491-04

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled Room Temperature].

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

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

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Manufactured by: 3M Drug Delivery Systems, Northridge CA, 91324. Revised: Oct 2013.

Last reviewed on RxList: 11/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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Climara Pro - User Reviews

Climara Pro User Reviews

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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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