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

 
 



SPL UNCLASSIFIED SECTION

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

ORAL CONTRACEPTIVE AGENTS

DESCRIPTION

Brevicon Tablets provide a continuous oral contraceptive regimen consisting of 21 blue tablets containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.

Norinyl 1+35 Tablets provide a continuous oral contraceptive regimen consisting of 21 yellow-green tablets containing norethindrone 1 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.

Norinyl 1+50 Tablets provide a continuous oral contraceptive regimen consisting of 21 white tablets containing norethindrone 1 mg and mestranol 0.05 mg and 7 orange tablets containing 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. Mestranol is an estrogen with the chemical name 3-Methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol. Their structural formulae follow:

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

The yellow-green NORINYL 1+35 tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.

The white NORINYL 1+50 tablets contain the following inactive ingredients: lactose, magnesium stearate, povidone, and starch.

The inactive orange tablets in the 28-day regimens of BREVICON, NORINYL 1+35 and NORINYL 1+50 contain the following 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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