Nortrel 7 / 7 / 7 (Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol) - Description and Clinical Pharmacology

MARCH 2004
31090110105

Rx only

DESCRIPTION

0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg

(21 Day Regimen) and (28 Day Regimen)

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

COMBINATION ORAL CONTRACEPTIVES:

Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen): Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include D&C yellow #10, lactose monohydrate, magnesium stearate and pregelatinized starch. Each blue tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C blue no. 1 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C yellow no. 6 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each white tablet in the (28) package contains only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized starch.

The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17α -pregna-1,3,5(10)-trien-20-yne-3, 17-diol.

The structural formulas are as follows:

Norethindrone C₂₀H₂₆O₂ Molecular Weight: 298.43

Ethinyl Estradiol C₂₀H₂₄O₂ Molecular Weight: 296.41

CLINICAL PHARMACOLOGY

COMBINATION ORAL CONTRACEPTIVES

Combination oral contraceptives act by suppression of gonadotropins. 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 reduce the likelihood of implantation).