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CombiPatch

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CombiPatch

CombiPatch

INDICATIONS

In women with an intact uterus, CombiPatch (estradiol, norethindrone acetate transdermal system) (estradiol/NETA transdermal system) is indicated for the following:

· Treatment of moderate to severe vasomotor symptoms associated with the menopause

· Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

· Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure

DOSAGE AND ADMINISTRATION

When estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g. 3-month to 6-month intervals) to determine whether treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Initiation of Therapy: Treatment of postmenopausal symptoms is usually initiated during the menopausal stage when vasomotor symptoms occur. Patients should be started at the lowest dose. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. The lowest effective dose of CombiPatch (estradiol, norethindrone acetate transdermal system) has not been determined in clinical trials.

Women not currently using continuous estrogen or combination estrogen/progestin therapy may start therapy with CombiPatch (estradiol, norethindrone acetate transdermal system) at any time. However, women currently using continuous estrogen or combination estrogen/progestin therapy should complete the current cycle of therapy, before initiating CombiPatch (estradiol, norethindrone acetate transdermal system) 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 CombiPatch (estradiol, norethindrone acetate transdermal system) therapy.

Therapeutic Regimens: Combination estrogen/progestin regimens are indicated for women with an intact uterus. Two CombiPatch (estradiol, norethindrone acetate transdermal system) (estradiol/NETA) transdermal delivery systems are available: 0.05 mg estradiol with 0.14 mg NETA per day (9 sq cm) and 0.05 mg estradiol with 0.25 mg NETA per day (16 sq cm). The lowest effective dose should be used. For all regimens, women should be reevaluated at 3- to 6-month intervals to determine if changes in hormone therapy or if continued hormone therapy is appropriate.

Continuous Combined Regimen

A CombiPatch (estradiol, norethindrone acetate transdermal system) 0.05 mg estradiol/0.14 mg NETA per day (9 sq cm) matrix transdermal system is worn continuously on the lower abdomen. Additionally, a dose of 0.05 mg estradiol/0.25 mg NETA (16 sq cm system) is available if a greater progestin dose is desired. A new system should be applied twice weekly during a 28-day cycle. Irregular bleeding may occur particularly in the first 6 months, but generally decreases with time, and often to an amenorrheic state.

Continuous Sequential Regimen :

CombiPatch (estradiol, norethindrone acetate transdermal system) can be applied as a sequential regimen in combination with an estradiol-only transdermal delivery system.

In this treatment regimen, an 0.05 mg per day (nominal delivery rate) estradiol transdermal system (Vivelle) is worn for the first 14 days of a 28-day cycle, replacing the system twice weekly according to product directions. For the remaining 14 days of the 28-day cycle, CombiPatch (estradiol, norethindrone acetate transdermal system) 0.05 mg estradiol/0.14 mg NETA per day (9 sq cm) transdermal system should be applied to the lower abdomen. Additionally, a dose of 0.05 mg estradiol / 0.25 mg NETA (16 sq cm system) is available if a greater progestin dose is desired. The CombiPatch (estradiol, norethindrone acetate transdermal system) system should be replaced twice weekly during this period in the cycle. Women should be advised that monthly withdrawal bleeding often occurs.

Application of the System

Site Selection : CombiPatch (estradiol, norethindrone acetate transdermal system) should be placed on a smooth (fold free), clean, dry area of the skin on the lower abdomen. CombiPatch (estradiol, norethindrone acetate transdermal system) 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 the system off or modify drug delivery. The sites of application must be rotated, with an interval of at least one week allowed between applications to the same site.

Application : After opening the pouch, remove one side of the protective liner, taking care not to touch the adhesive part of the transdermal delivery system with the fingers. Immediately apply the transdermal delivery system to a smooth (fold free) area of skin on the lower abdomen. Remove the second side of the protective liner and press the system firmly in place with the hand for at least 10 seconds, making sure there is good contact, especially around the edges.

Care should be taken that the system does not become dislodged during bathing and other activities. If a system should fall off, the same system may be reapplied to another area of the lower abdomen. If necessary, a new transdermal 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 the 3- to 4-day dosing interval.

Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time.

Removal of the 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.

HOW SUPPLIED

CombiPatch (estradiol, norethindrone acetate transdermal system) estradiol/norethindrone acetate transdermal delivery system is available in:

System Size Nominal Delivery Rate* Estradiol / Norethindrone Acetate Presentation NDC Markings
9 sq cm 0.05 / 0.14 mg per day 8 systems per carton 0078-0377-42 CombiPatch 0.05/0.14 mg per day
    Cartons of 3 patient packs of 8 systems 0078-0377-45  
16 sq cm 0.05 / 0.25 mg per day 8 systems per carton 0078-0378-42 CombiPatch 0.05/0.25 mg per day
    Cartons of 3 patient packs of 8 systems 0078-0378-45  
* Nominal delivery rate described. See DESCRIPTION for more details regarding drug delivery.

Storage Conditions: Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing to the patient, CombiPatch (estradiol, norethindrone acetate transdermal system) can be stored at room temperature below 25°C (77°F) for up to 6 months. For the Pharmacist: When CombiPatch (estradiol, norethindrone acetate transdermal system) is dispensed to the patient, place an expiration date on the label. The date should not exceed either 6 months from the date of sale or the expiration date, whichever comes first.

Store the systems in the sealed foil pouch.

Do not store the system in areas where extreme temperatures can occur.

Keep out of the reach of children.

REV: NOVEMBER 2005
CombiPatch (estradiol, norethindrone acetate transdermal system) is a registered trademark of Novartis Pharmaceuticals Corporation.
REV: NOVEMBER 2005
Manufactured by : Noven Pharmaceuticals Inc.
Miami, FL 33186
Novartis
Distributed by : Novartis Pharmaceuticals Corporation East Hanover,
NJ 07936
FDA revision date: 11/16/05

Last reviewed on RxList: 10/5/2006
This monograph has been modified to include the generic and brand name in many instances.

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CombiPatch - User Reviews

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