Climara
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
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.
History
There is currently no drug history available for this drug.
Other Information
Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm2, and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical.
Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18 H24 O2 and molecular weight of 272.38. The structural formula is:
The Climara transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are:
- 1.
- A translucent polyethylene film.
- 2.
- An acrylate adhesive matrix containing estradiol USP.
- 3.
- A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used.
The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive.
Sources
Climara Manufacturers
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Bayer Healthcare Pharmaceuticals Inc.
![Climara (Estradiol) Patch [Bayer Healthcare Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Climara | Bayer Healthcare Pharmaceuticals Inc.
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 a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].
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.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to MenopauseStart therapy with 0.025 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 taper or discontinue the medication should be made at 3 to 6 month intervals.
2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to MenopauseStart therapy with 0.025 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 taper or discontinue the medication should be made at 3 to 6 month intervals.
2.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian FailureStart therapy with 0.025 mg per day applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Climara transdermal system, especially in women with an intact uterus.
2.4 Prevention of Postmenopausal OsteoporosisStart therapy with 0.025 mg per day applied to the skin once weekly.
2.5 Application of the Climara Transdermal System Site Selection • The adhesive side of Climara should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. • Climara 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 the 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 Climara should also be avoided. Application • Climara should be applied immediately after opening the pouch and removing the protective liner. • Climara 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 Climara has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol. 2.6 Removal of the Climara Transdermal System • Removal of Climara should be done carefully and slowly to avoid irritation of the skin. • Should any adhesive remain on the skin after removal of the Climara 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.
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