Philith

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

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

28-Day Regimen

Rx Only

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

Philith Description

Philith™ 28-Day (norethindrone and ethinyl estradiol tablets, USP) provide a continuous regimen for oral contraception derived from 21 tan tablets composed of norethindrone and ethinyl estradiol to be followed by 7 white tablets of inert ingredients. The structural formulas are:

NORETHINDRONE ETHINYL ESTRADIOL

C20H26O2 Molecular Weight: 298.42 C20H24O2 Molecular Weight: 296.40

The tan active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, iron oxide yellow, iron oxide black, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized starch. The white tablets in the 28-Day regimen contain only inert ingredients as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

CLINICAL PHARMACOLOGY

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 Philith

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.<...