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Minivelle

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Minivelle

INDICATIONS

MINIVELLE is indicated for treatment of moderate to severe vasomotor symptoms due to menopause.

DOSAGE AND ADMINISTRATION

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should 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].

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.

Treatment of Moderate to Severe Vasomotor Symptoms

Start therapy with MINIVELLE 0.0375 mg per day applied to the skin twice weekly. Dosage adjustment should be guided by the clinical response.

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.

The adhesive side of MINIVELLE should be placed on a clean, dry area on the lower abdomen (below the umbilicus) or buttocks. MINIVELLE should not be applied to the breasts. MINIVELLE should be replaced twice weekly (every 3-4 days).

The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site.

The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact with the skin, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the same system cannot be reapplied, a new system should be applied to another location. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. In either case, the original treatment schedule should be continued. The interruption of treatment in women taking MINIVELLE might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.

HOW SUPPLIED

Dosage Forms And Strengths

Transdermal system 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.

MINIVELLE (estradiol transdermal system), 0.0375 mg per day - each 2.48 cm² system contains 0.62mg of estradiol USP for nominal* delivery of 0.0375 mg of estradiol per day.

Patient Calendar Pack of 8 Systems…………………..NDC 68968-6637-8
Carton of 3 Patient Calendar Packs of 8 Systems…….NDC 68968-6637-3

MINIVELLE (estradiol transdermal system), 0.05 mg per day - each 3.3 cm² system contains 0.83 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol per day.

Patient Calendar Pack of 8 Systems………………….NDC 68968-6650-x
Carton of 3 Patient Calendar Packs of 8 Systems……NDC 68968-6650-x

MINIVELLE (estradiol transdermal system), 0.075 mg per day - each 4.95 cm² system contains 1.24 mg of estradiol USP for nominal* delivery of 0.075 mg of estradiol per day.

Patient Calendar Pack of 8 Systems………………….NDC 68968-6675-8
Carton of 3 Patient Calendar Packs of 8 Systems……NDC 68968-6675-3

MINIVELLE (estradiol transdermal system), 0.1 mg per day - each 6.6 cm² system contains 1.65mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol per day.

Patient Calendar Pack of 8 Systems………………….NDC 68968-6610-8
Carton of 3 Patient Calendar Packs of 8 Systems……NDC 68968-6610-3

* See DESCRIPTION

Storage and Handling

Store at room temperature 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 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 sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

Manufactured by: Noven Pharmaceuticals Inc., Miami, FL 33186. Approved 10/2012

Last reviewed on RxList: 11/30/2012
This monograph has been modified to include the generic and brand name in many instances.

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