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Balziva
  • Professionals
  • FDA PI

Balziva

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

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

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

Balziva Description

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

Norethindrone, USP Ethinyl Estradiol, USP

C20H26O2 M.W. 298.42 C20H24O2 M.W. 296.40

The light peach active tablets each contain 0.4 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP, and contain the following inactive ingredients: anhydrous lactose, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate. The white tablets contain only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized corn starch.

Balziva - 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 Balziva

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

Oral contraceptives ...