Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 80 28 versus ORTHO NOVUM 10 21.
Head-to-head clinical analysis: ORTHO NOVUM 1 80 28 versus ORTHO NOVUM 10 21.
ORTHO-NOVUM 1/80 28 vs ORTHO-NOVUM 10-21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination estrogen-progestin contraceptive; primarily inhibits ovulation by suppressing gonadotropin release (FSH and LH). Also increases cervical mucus viscosity and alters endometrial receptivity.
Combination estrogen-progestin contraceptive; suppresses gonadotropin release (FSH, LH) from pituitary, inhibiting ovulation; increases viscosity of cervical mucus and alters endometrial lining, reducing sperm penetration and implantation.
One tablet orally once daily at the same time each day for 28 days (21 active tablets containing norethindrone 1 mg and ethinyl estradiol 80 mcg, followed by 7 placebo tablets).
1 tablet (1 mg norethindrone, 0.035 mg ethinyl estradiol) orally once daily for 21 days, followed by 7 days of no tablets.
None Documented
None Documented
Norethindrone: 7-8 hours; mestranol: 10-13 hours (terminal). Steady-state achieved in 5-7 days.
Norethindrone 5-14 hours (mean 8 hours), ethinyl estradiol 7-20 hours (mean 13 hours). Steady-state achieved in 5-10 days.
Norethindrone: 50-60% renal, 20-30% fecal; mestranol: 30-40% renal, 60-70% fecal.
Renal approximately 50-60% as metabolites, biliary/fecal approximately 30-40% as metabolites and unchanged drug.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive