Pirmella 1/35

Generic name:norethindrone and ethinyl estradiol
Dosage form: tablets
Drug classes:Contraceptives, Sex hormone combinations

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

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

COMBINATION ORAL CONTRACEPTIVES

Pirmella™ 1/35 is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.

Pirmella 1/35:

Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose anhydrous, magnesium stearate and pregelatinized starch. Each green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose 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. Their structural formulas are as follows:

Pirmella 1/35 - 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).

Indications and Usage for Pirmella 1/35

Pirmella 1/35 is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT® System depends upon the reliability with which ...