Zovia 1/35E-28
Zovia 1/50E-28
(Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP)
Revised: December 2003
Rx only
SPL UNCLASSIFIED SECTION
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
Zovia 1/35E-28. Each light pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/35E-28 package is a placebo containing no active ingredients and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose.
Zovia 1/50E-28. Each pink tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/50E-28 package is a placebo containing no active ingredients, and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose.
The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β,17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.
The structural formulas are as follows:
 
Therapeutic class: Oral contraceptive.
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CLINICAL PHARMACOLOGY
Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation) may also contribute to contraceptive effectiveness.
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