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Wera
  • Professionals
  • FDA PI

Wera

Generic name:norethindrone and ethinyl estradiol
Dosage form: tablets
Drug classes:Contraceptives, Sex hormone combinations

Medically reviewed by Drugs.com. Last updated on Oct 22, 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 WeraTM, 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.

Each light peach tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol.

Inactive ingredients include: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide red, lactose monohydrate, magnesium stearate and pregelatinized starch. Each white tablet contains only inert ingredients, as follows: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

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

Wera - Clinical Pharmacology

Combined Oral Contraceptives

Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm e...