Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 7 14 21 versus TRI NORINYL 28 DAY.
Head-to-head clinical analysis: ORTHO NOVUM 7 14 21 versus TRI NORINYL 28 DAY.
ORTHO-NOVUM 7/14-21 vs TRI-NORINYL 28-DAY
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination estrogen-progestin contraceptive: suppresses gonadotropin release, inhibits ovulation, thickens cervical mucus, alters endometrial receptivity.
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Suppresses gonadotropin (FSH and LH) release via negative feedback, inhibiting ovulation. Also increases viscosity of cervical mucus and alters endometrial lining to reduce implantation likelihood.
One tablet containing 0.5 mg norethindrone/0.035 mg ethinyl estradiol (white tablets) on days 1-14, then one tablet containing 1 mg norethindrone/0.035 mg ethinyl estradiol (peach tablets) on days 15-21, then no tablets for 7 days; repeated cycles.
One tablet orally once daily for 21 days, followed by one placebo tablet orally once daily for 7 days. Each active tablet contains 0.035 mg ethinyl estradiol and 0.5 mg norethindrone (7 days), 0.035 mg ethinyl estradiol and 1.0 mg norethindrone (9 days), and 0.035 mg ethinyl estradiol and 0.5 mg norethindrone (5 days).
None Documented
None Documented
Norethindrone: 10-12 hours (terminal), ethinyl estradiol: 13-27 hours (terminal); clinical context: steady state achieved within 5-7 days
Ethinyl estradiol: 17 ± 6 hours (terminal); Norethindrone: 10 ± 3 hours (terminal). Steady-state achieved after 7-14 days.
Renal: ~40% as glucuronide and sulfate conjugates; Fecal: ~20%; Biliary: minor
Renal: 40% as metabolites; Fecal: 50% as metabolites; Biliary: minor; unchanged ethinyl estradiol excreted in urine <5%, norethindrone <1%.
Category C
Category C
Oral Contraceptive
Oral Contraceptive