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Kelnor 1 / 35 (Ethynodiol Diacetate / Ethinyl Estradiol) - Description and Clinical Pharmacology

 
 



Kelnor™ 1/35 (28 Day Regimen)
(ethynodiol diacetate and ethinyl
estradiol tablets, USP)

Revised MAY 2006
11001031

Rx only

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

DESCRIPTION:

Kelnor™ 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, 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:

Ethynodiol Diacetate: C<sub>24</sub>H<sub>32</sub>O<sub>4</sub>                                          Molecular Weight:  384.51

Ethynodiol Diacetate: C24H32O4 Molecular Weight: 384.51

Ethinyl Estradiol C<sub>20</sub>H<sub>24</sub>O<sub>2</sub>                                  Molecular Weight:  296.40

Ethinyl Estradiol C20H24O2 Molecular Weight: 296.40

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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