Comparative Pharmacology
Head-to-head clinical analysis: ORTHO NOVUM 7 7 7 21 versus TATUM T.
Head-to-head clinical analysis: ORTHO NOVUM 7 7 7 21 versus TATUM T.
ORTHO-NOVUM 7/7/7-21 vs TATUM-T
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
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.
TATUM-T is a combination of ethynodiol diacetate, a progestin, and ethinyl estradiol, an estrogen. It suppresses gonadotropin (FSH and LH) release from the pituitary, inhibiting ovulation. Additionally, it increases viscosity of cervical mucus, impeding sperm penetration, and alters the endometrium to reduce implantation likelihood.
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.
One tablet (ethinyl estradiol 0.035 mg / norgestimate 0.250 mg) orally once daily for 21 days, followed by 7 days of placebo.
None Documented
None Documented
Ethinyl estradiol: 13-27 hours; norethindrone: 8-14 hours; with multiple dosing, steady state after 5-7 days.
Terminal elimination half-life of 12-15 hours in healthy adults; prolonged in renal impairment (up to 30 hours in creatinine clearance <30 mL/min) requiring dose adjustment
Renal: <10% unchanged; biliary/fecal: ~50% as metabolites; extensive enterohepatic recirculation.
Primarily renal (65-70% as unchanged drug); biliary/fecal (20-25%); minor metabolism to inactive glucuronide conjugates (<10%)
Category C
Category C
Oral Contraceptive
Oral Contraceptive