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Nylia 7/7/7
  • Professionals
  • FDA PI

Nylia 7/7/7

Generic name:norethindrone and ethinyl estradiol
Dosage form: tablets
Drug class:Contraceptives

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including NyliaTM, should not be used by women who are over 35 years of age and smoke.

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

COMBINED ORAL CONTRACEPTIVES

The following product is a combined oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.

NyliaTM 7/7/7 Tablets:

Each white to off-white tablet contains 0.5 mg of norethindrone USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include anhydrous lactose, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Each light peach tablet contains 0.75 mg of norethindrone USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include anhydrous lactose, FD&C Yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Each peach tablet contains 1 mg of norethindrone USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include anhydrous lactose, FD&C Yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Each green tablet contains only inert ingredients, as follows: anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.

The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, and for ethinyl estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulas are as f.