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NDC 70700-0118-85

Levonorgestrel and Ethinyl Estradiol KIT

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NDC
70700-0118-85
Generic Name
Levonorgestrel and Ethinyl Estradiol
Brand Name
Vienva
Strength
—
Dosage Form
KIT
Route
—
Package Size
—
Labeler
Xiromed, LLC.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use : The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an over…

Important Warnings

WARNINGS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including levonorgestrel and ethinyl estradiol, are contraindicated in women…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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