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.
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.
Noncontraceptive Health Benefits
The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.Effects On Menses
- Increased menstrual cycle regularity
- Decreased blood loss and decreased incidence of iron deficiency anemia
- Decreased incidence of dysmenorrheal
- Decreased incidence of functional ovarian cysts
- Decreased incidence of ectopic pregnancies
- Decreased incidence of fibroadenomas and fibrocystic disease of the breast
- Decreased incidence of acute pelvic inflammatory disease
- Decreased incidence of endometrial cancer
- Decreased incidence of ovarian cancer
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).