Vivelle-dot

Vivelle-dot

Vivelle-dot Recall

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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

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Vivelle-Dot is indicated for:

1.1     Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2     Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause

Limitation of Use

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

1.3     Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure
1.4     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 medications should be carefully considered.

History

There is currently no drug history available for this drug.

Other Information

Vivelle-Dot (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 Vivelle-Dot 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 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 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:

Estradiol structural formula

The molecular formula of estradiol is C18H2402. The molecular weight is 272.39.

Vivelle-Dot is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (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.

Vivelle-Dot layer image ----- (1) Backing

----- (2) Adhesive Containing Estradiol

----- (3) Protective Liner

The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.

Vivelle-dot Manufacturers


  • Novartis Pharmaceuticals Corporation
    Vivelle-dot (Estradiol) Patch, Extended Release [Novartis Pharmaceuticals Corporation]

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