Comparative Pharmacology
Head-to-head clinical analysis: DASETTA 1 35 versus ORTHO NOVUM 7 7 7 21.
Head-to-head clinical analysis: DASETTA 1 35 versus ORTHO NOVUM 7 7 7 21.
DASETTA 1/35 vs ORTHO-NOVUM 7/7/7-21
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).
Combined hormonal contraceptive; primarily suppresses ovulation via inhibition of gonadotropin release (LH and FSH) from the pituitary. Also induces changes in cervical mucus and endometrium.
One tablet orally once daily, each containing 1 mg norethindrone acetate and 35 mcg ethinyl estradiol.
One tablet orally once daily for 21 days, followed by 7 days of no tablets. Each tablet contains norethindrone 0.5 mg/0.75 mg/1 mg and ethinyl estradiol 35 mcg, with biphasic or triphasic dosing per cycle.
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.
Ethinyl estradiol: 13-27 hours; norethindrone: 8-14 hours; with multiple dosing, steady state after 5-7 days.
Renal (55-60% as metabolites, 25-30% as unchanged drug and conjugates), biliary/fecal (30-35% as metabolites).
Renal: <10% unchanged; biliary/fecal: ~50% as metabolites; extensive enterohepatic recirculation.
Category C
Category C
Oral Contraceptive
Oral Contraceptive