Seasonique (Levonorgestrel / Ethinyl Estradiol / Ethinyl Estradiol) - Description

Rx only

Patients sh ould be counseled that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

Seasonique^TM (levonorgestrel/ethinyl estradiol combination tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The chemical formula of levonorgestrel USP is 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α-, (-)-, and the chemical formula of ethinyl estradiol USP is 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. The structural formulas are as follows:

Levonorgestrel C₂₁H₂₈O₂ MW: 312.4

Ethinyl Estradiol C₂₀H₂₄O₂ MW: 296.4

Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.

Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.