Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 10 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ORTHO NOVUM 1 35 28 versus ORTHO NOVUM 10 21.
ORTHO-NOVUM 1/35-28 vs ORTHO-NOVUM 10-21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Inhibits ovulation by suppressing gonadotropin release (FSH and LH) from the pituitary; increases viscosity of cervical mucus, impeding sperm penetration; alters endometrial lining, reducing implantation likelihood.
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.
1 tablet (norethindrone 1 mg / ethinyl estradiol 35 mcg) orally once daily for 28 consecutive days. Placebo tablets on days 22-28 if included.
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: 5-14 hrs (terminal); ethinyl estradiol: 10-24 hrs. Steady-state achieved within 5-7 days; terminal half-life supports once-daily dosing.
Norethindrone 5-14 hours (mean 8 hours), ethinyl estradiol 7-20 hours (mean 13 hours). Steady-state achieved in 5-10 days.
Renal 50-60% as metabolites; fecal 30-40% via biliary elimination; <1% unchanged in urine.
Renal approximately 50-60% as metabolites, biliary/fecal approximately 30-40% as metabolites and unchanged drug.
Category C
Category C
Hormonal Contraceptive
Hormonal Contraceptive