ORTHO-NOVUM 7/14-28
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORTHO-NOVUM 7/14-28 (ORTHO-NOVUM 7/14-28).
Combination oral contraceptive containing ethinyl estradiol and norethindrone. Suppresses gonadotropin release (FSH, LH) via negative feedback, inhibiting ovulation. Also increases cervical mucus viscosity and alters endometrial receptivity.
| Metabolism | Ethinyl estradiol: primarily metabolized via CYP3A4, undergoes first-pass metabolism and enterohepatic circulation. Norethindrone: reduced to metabolites, conjugated (glucuronidation and sulfation), and excreted in urine and feces. |
| Excretion | Renal: ~50-60% (metabolites); biliary/fecal: ~30-40% (metabolites); unchanged drug <1% in urine. |
| Half-life | Ethinyl estradiol: ~13-27 h (mean 17 h); Norethindrone: ~5-14 h (mean 8 h). Clinical context: steady-state achieved after ~5 days; half-life supports daily dosing. |
| Protein binding | Ethinyl estradiol: 97-98% bound to serum albumin; Norethindrone: 97-99% bound to albumin (major) and SHBG (minor). |
| Volume of Distribution | Ethinyl estradiol: 2.3-4.2 L/kg (mean 3.5 L/kg); Norethindrone: 2.5-5.0 L/kg (mean 3.8 L/kg). Clinical meaning: extensive distribution into tissues, including reproductive organs. |
| Bioavailability | Oral: Ethinyl estradiol ~40-48% (first-pass metabolism); Norethindrone ~50-70% (first-pass metabolism). Food may slightly increase bioavailability. |
| Onset of Action | Oral: Pharmacodynamic effect (ovulation suppression) begins within 2-3 days of initiation when started on day 1 of cycle. Contraceptive effect requires 7 days of continuous use if started after day 5. |
| Duration of Action | Oral: Contraceptive effect maintained for the 21-day active pill period; withdrawal bleed occurs during the 7-day placebo interval. Duration of pharmacodynamic effects (e.g., endometrial suppression) persists for the dosing interval. |
One tablet daily for 28 days; each tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg (days 1-7), norethindrone 0.75 mg and ethinyl estradiol 0.035 mg (days 8-14), norethindrone 1 mg and ethinyl estradiol 0.035 mg (days 15-21), and placebo (days 22-28). Take at same time each day.
| Dosage form | TABLET |
| Renal impairment | No specific dose adjustment recommended in published literature; however, use with caution in patients with severe renal impairment (eGFR <30 mL/min) due to potential fluid retention and electrolyte disturbances. No data for specific GFR-based modifications. |
| Liver impairment | Contraindicated in patients with severe hepatic disease (Child-Pugh class C) or hepatic tumors. For Child-Pugh class A or B, use with caution; no specific dose adjustment guidelines exist. Discontinue if jaundice or signs of hepatic dysfunction develop. |
| Pediatric use | Not indicated for use before menarche. For post-menarcheal adolescents, same dosing as adults: one tablet daily for 28 days. Use only after appropriate evaluation and counseling. |
| Geriatric use | Not indicated for use in postmenopausal women. Elderly-specific dosing not applicable. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ORTHO-NOVUM 7/14-28 (ORTHO-NOVUM 7/14-28).
| Breastfeeding | Combined oral contraceptives, including Ortho-Novum, are generally not recommended during breastfeeding, especially in the early postpartum period, due to estrogen-induced reduction in milk production and quality. Small amounts of ethinylestradiol and norethindrone are excreted in breast milk. M/P ratio for ethinylestradiol is approximately 0.15–0.3; for norethindrone, approximately 0.5–1.2. Progestin-only methods are preferred. Use only when no alternative and with caution. |
| Teratogenic Risk | First trimester: Post-marketing studies have not shown an increased risk of birth defects with combined oral contraceptives. However, inadvertent use during early pregnancy is not associated with teratogenicity. Second and third trimesters: Use is contraindicated due to potential adverse effects on fetal development, including estrogenic effects on female fetuses and androgenic effects on male fetuses. There is a risk of fetal genital abnormalities if exposed in utero, though absolute risk is low. Overall, category X designation for use during pregnancy. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events. Women over 35 who smoke should not use this product.
| Serious Effects |
["Known or suspected pregnancy","Current or past history of thromboembolic disorders (e.g., DVT, PE)","Cerebrovascular or coronary artery disease","Known or suspected breast cancer","Active liver disease or benign/malignant liver tumors","Undiagnosed abnormal genital bleeding","Hypersensitivity to any component","Age >35 and smoking cigarettes","Uncontrolled hypertension","Diabetes with vascular involvement","Migraine with focal aura at any age","Major surgery with prolonged immobilization"]
| Precautions | ["Increased risk of thromboembolic disorders (DVT, PE, stroke, MI)","Cigarette smoking increases cardiovascular risk","Increased risk of cervical cancer (HPV-related)","Hepatic neoplasia (benign/malignant) associated with long-term use","Exacerbation of migraine","Depression","Gallbladder disease","Impaired glucose tolerance","Elevated blood pressure","Hereditary angioedema"] |
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| Fetal Monitoring | Monitor blood pressure regularly due to potential hypertensive effects. Assess for signs of thromboembolism, especially in pregnancy or postpartum. Perform pregnancy test before initiation. If accidental use during pregnancy, monitor fetal growth and development via ultrasound. No specific additional fetal monitoring required beyond standard prenatal care. |
| Fertility Effects | Upon discontinuation, fertility typically returns promptly, though some women may experience a temporary delay in ovulation or menstrual regularity. No permanent impairment of fertility has been demonstrated. Long-term use may be associated with a slight delay in return to fertility but no irreversible effects. |