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Levora (Levonorgestrel / Ethinyl Estradiol) - Description and Clinical Pharmacology

 
 



WATSON PHARMA
Revised: May 2005
IN-5262/S
PHYSICIAN LABELING
Levora 0.15/30-28
(levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg)
Rx only

ORAL CONTRACEPTIVE AGENTS DESCRIPTION

Levora 0.15/30-28 Tablets provide an oral contraceptive regimen consisting of 21 white tablets containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg followed by 7 peach tablets containing inert ingredients.

Levonorgestrel is a totally synthetic progestogen with the chemical name ()-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:

LEVONORGESTREL

LEVONORGESTREL

ETHINYL ESTRADIOL

ETHINYL ESTRADIOL

The white Levora 0.15/30 tablets contain the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

The inactive peach tablets in the 28-day regimen of Levora 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.

CLINICAL PHARMACOLOGY

Combination oral contraceptives act by suppression of gonadotrophins. 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 entry into the uterus) and the endometrium (which may reduce the likelihood of implantation).

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