Minivelle
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
MINIVELLE is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
MINIVELLE is indicated for the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
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 medications should be carefully considered.
MINIVELLE is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
1.2 Prevention of Postmenopausal OsteoporosisMINIVELLE is indicated for the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
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 medications should be carefully considered.
History
There is currently no drug history available for this drug.
Other Information
MINIVELLE (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin.
Five dosage strengths of MINIVELLE are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 1.65, 2.48, 3.30, 4.95, or 6.6 cm2 and contains 0.41, 0.62, 0.83, 1.24, or 1.65 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.
The structural formula is
The molecular formula of estradiol is C18H2402. The molecular weight is 272.39
MINIVELLE is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a polyester film laminate (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used.
The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.
Sources
Minivelle Manufacturers
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Noven Therapeutics, Llc
![Minivelle (Estradiol) Film, Extended Release [Noven Therapeutics, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Minivelle | Noven Therapeutics, Llc
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 (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 SymptomsStart 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.
2.2 Prevention of Postmenopausal OsteoporosisStart therapy with MINIVELLE 0.025 mg per day applied to the skin twice weekly. The dose may be adjusted as necessary.
2.3 Patch Application InstructionsThe 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.
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