Comparative Pharmacology
Head-to-head clinical analysis: DASETTA 1 35 versus ORTHO NOVUM 7 14 21.
Peer-Reviewed Evidence
Head-to-head clinical analysis: DASETTA 1 35 versus ORTHO NOVUM 7 14 21.
DASETTA 1/35 vs ORTHO-NOVUM 7/14-21
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Combination of an estrogen (ethinyl estradiol) and a progestin (norethindrone). Suppresses gonadotropin-releasing hormone (GnRH) from the hypothalamus, reducing luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from the pituitary, thereby inhibiting ovulation. Additionally, induces changes in cervical mucus (impenetrability to sperm) and endometrium (reduced likelihood of implantation).
Combination estrogen-progestin contraceptive: suppresses gonadotropin release, inhibits ovulation, thickens cervical mucus, alters endometrial receptivity.
One tablet orally once daily, each containing 1 mg norethindrone acetate 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: 5-14 hours (mean 8 hours); ethinyl estradiol: 10-20 hours (mean 14 hours). Clinical context: steady-state achieved within 5-7 days.
Norethindrone: 10-12 hours (terminal), ethinyl estradiol: 13-27 hours (terminal); clinical context: steady state achieved within 5-7 days
Renal (55-60% as metabolites, 25-30% as unchanged drug and conjugates), biliary/fecal (30-35% as metabolites).
Renal: ~40% as glucuronide and sulfate conjugates; Fecal: ~20%; Biliary: minor
Category C
Category C
Oral Contraceptive
Oral Contraceptive