ORTHO-NOVUM 7/14-21
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORTHO-NOVUM 7/14-21 (ORTHO-NOVUM 7/14-21).
Combination estrogen-progestin contraceptive: suppresses gonadotropin release, inhibits ovulation, thickens cervical mucus, alters endometrial receptivity.
| Metabolism | Ethinyl estradiol undergoes hepatic oxidation via CYP3A4 and conjugation; norethindrone primarily hepatic reduction and conjugation. |
| Excretion | Renal: ~40% as glucuronide and sulfate conjugates; Fecal: ~20%; Biliary: minor |
| Half-life | Norethindrone: 10-12 hours (terminal), ethinyl estradiol: 13-27 hours (terminal); clinical context: steady state achieved within 5-7 days |
| Protein binding | Norethindrone: 80-90% bound to SHBG and albumin; Ethinyl estradiol: 97-98% bound to albumin and SHBG |
| Volume of Distribution | Norethindrone: 2.5-4 L/kg; Ethinyl estradiol: 2.5-3 L/kg; clinical meaning: extensive tissue distribution |
| Bioavailability | Norethindrone: 64%; Ethinyl estradiol: 38-48% (oral, due to first-pass metabolism) |
| Onset of Action | Oral: suppression of ovulation begins after 7 consecutive days of use |
| Duration of Action | Oral: 24 hours (maintains contraceptive efficacy with daily dosing); note: missed pills reduce effectiveness |
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.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment necessary for mild to moderate renal impairment. Avoid use in severe renal impairment (eGFR <30 mL/min/1.73 m²) due to potential fluid retention and hyperkalemia. |
| Liver impairment | Contraindicated in acute hepatic disease or Child-Pugh Class B and C cirrhosis. For Child-Pugh Class A, use with caution and monitor liver function; no specific dose adjustment guidelines available. |
| Pediatric use | Not indicated for use in children; contraindicated prior to menarche. |
| Geriatric use | Not indicated for use in postmenopausal women; avoid use in elderly due to increased risk of thrombotic and cardiovascular events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ORTHO-NOVUM 7/14-21 (ORTHO-NOVUM 7/14-21).
| Breastfeeding | Combination oral contraceptives may reduce milk production and pass into breast milk. M/P ratio is not well-defined. Use during breastfeeding is generally not recommended; progestin-only contraceptives are preferred. |
| Teratogenic Risk | Combination hormonal contraceptives (estrogen-progestin) are contraindicated in pregnancy. First trimester exposure is associated with a low risk of congenital anomalies; however, second and third trimester exposure may increase risks of fetal genital tract abnormalities and possibly other adverse outcomes. Use is not recommended during any trimester. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combination oral contraceptives. Risk increases with age and heavy smoking (≥15 cigarettes/day). Women over 35 who smoke should not use this product.
| Serious Effects |
["Thrombophlebitis or thromboembolic disorders","History of DVT/PE","Cerebrovascular or coronary artery disease","Known or suspected breast carcinoma","Estrogen-dependent neoplasia","Undiagnosed abnormal genital bleeding","Pregnancy","Liver tumors (benign or malignant) or active liver disease","Hypersensitivity to any component","Age >35 and smoking ≥15 cigarettes/day"]
| Precautions | ["Increased risk of thromboembolic disorders (stroke, MI, DVT/PE)","Hepatic neoplasia risk","Elevated blood pressure","Gallbladder disease","Carbohydrate/lipid metabolism effects","Ocular lesions (retinal thrombosis)","Depression","Drug interactions (e.g., rifampin, anticonvulsants)"] |
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| Fetal Monitoring | If inadvertent use in early pregnancy occurs, no specific monitoring is required beyond routine prenatal care. Advise discontinuation if pregnancy is confirmed. |
| Fertility Effects | Ortho-Novum 7/14-21 is used for contraception and does not impair long-term fertility. Return to fertility typically occurs within a few months after discontinuation. |