Comparative Pharmacology
Head-to-head clinical analysis: NORTREL 0 5 35 21 versus ORTHO NOVUM 7 14 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: NORTREL 0 5 35 21 versus ORTHO NOVUM 7 14 21.
NORTREL 0.5/35-21 vs ORTHO-NOVUM 7/14-21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination hormonal contraceptive containing norethindrone (a progestin) and ethinyl estradiol (an estrogen). Norethindrone inhibits ovulation by suppressing gonadotropin release (LH and FSH) and alters cervical mucus and endometrial receptivity. Ethinyl estradiol provides negative feedback on the hypothalamic-pituitary-ovarian axis, further suppressing ovulation.
Combination estrogen-progestin contraceptive: suppresses gonadotropin release, inhibits ovulation, thickens cervical mucus, alters endometrial receptivity.
1 tablet orally once daily for 21 days, followed by 7 days off. Each tablet contains 0.5 mg norethindrone and 35 mcg ethinyl estradiol.
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.
None Documented
None Documented
Norethindrone: terminal half-life approximately 7-8 hours. Ethinyl estradiol: terminal half-life approximately 13-27 hours, mean about 17 hours. Ethinyl estradiol exhibits a longer half-life due to enterohepatic recirculation and extensive tissue distribution.
Norethindrone: 10-12 hours (terminal), ethinyl estradiol: 13-27 hours (terminal); clinical context: steady state achieved within 5-7 days
Norethindrone is primarily excreted renally (approximately 60-80% as metabolites) and approximately 20-40% fecally. Ethinyl estradiol is excreted renally (about 40%) and fecally (about 60%) as glucuronide and sulfate conjugates.
Renal: ~40% as glucuronide and sulfate conjugates; Fecal: ~20%; Biliary: minor
Category C
Category C
Oral Contraceptive
Oral Contraceptive