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Leena (Norethindrone / Ethinyl Estradiol) - Description and Clinical Pharmacology

 
 



WATSONPHARMA
IN-5264/S
PHYSICIAN LABELING
Leena
(Norethindrone and Ethinyl Estradiol Tablets USP)
Rx only

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

ORAL CONTRACEPTIVE AGENTS

DESCRIPTION

Leena provides a continuous oral contraceptive regimen of 7 light blue tablets, 9 light yellow-green tablets, 5 more light blue tablets, and then 7 orange tablets. Each light blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each light yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients.

Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-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.

The light yellow-green Leena tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.

The light blue Leena tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch.

The inactive orange tablets in the 28-day regimen contain the following inactive ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate.

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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