AUROVELA 1/20
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AUROVELA 1/20 (AUROVELA 1/20).
Combination estrogen-progestin contraceptive; suppresses gonadotropin (FSH, LH) release, inhibiting ovulation, altering cervical mucus, and reducing endometrial receptivity.
| Metabolism | Ethinyl estradiol: primarily metabolized by CYP3A4, undergoes first-pass metabolism. Norethindrone: primarily metabolized by CYP3A4, also undergoes first-pass metabolism. |
| Excretion | Renal (30–40% as metabolites, <5% unchanged); biliary/fecal (40–60% as metabolites). |
| Half-life | Norethindrone: ~8–11 hours (terminal); ethinyl estradiol: ~13–19 hours (terminal). Steady-state achieved within 5–7 days. |
| Protein binding | Norethindrone: ~61% bound to albumin, 36% to SHBG; ethinyl estradiol: ~98% bound to albumin. |
| Volume of Distribution | Norethindrone: ~2.5–4 L/kg; ethinyl estradiol: ~2.5–4 L/kg. Distribution into breast milk and body tissues. |
| Bioavailability | Oral: norethindrone ~64%, ethinyl estradiol ~45–55% due to first-pass metabolism. |
| Onset of Action | Oral: 7 days of continuous dosing required to achieve contraceptive effect; ovulation inhibition begins after first cycle. |
| Duration of Action | 24 hours (daily dosing); contraceptive protection requires consistent daily administration. Missed doses reduce efficacy. |
One tablet orally once daily at the same time each day for 21 days, followed by 7 placebo tablets. Each tablet contains ethinyl estradiol 0.02 mg and norethindrone acetate 1 mg.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Not recommended in severe renal impairment (eGFR <30 mL/min/1.73 m²) due to potential fluid retention and hypertension. |
| Liver impairment | Contraindicated in Child-Pugh Class C (severe hepatic impairment). Use with caution in Child-Pugh A or B; monitor liver function and consider alternative contraception if liver disease is active. |
| Pediatric use | Not indicated for use before menarche. For post-menarcheal adolescents, same dose as adults: one tablet orally once daily. |
| Geriatric use | Not indicated for use after menopause. For perimenopausal women, same dose as adults until menopause; monitor for thromboembolic risk due to age and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AUROVELA 1/20 (AUROVELA 1/20).
| Breastfeeding | Excreted in breast milk in small amounts (M/P ratio ~0.3). Not known to cause adverse effects in nursing infants at typical doses. Use with caution; may reduce milk production. |
| Teratogenic Risk | First trimester: No increased risk of major birth defects based on large epidemiological studies. Second and third trimesters: Associated with increased risk of intrauterine growth restriction (IUGR), preterm birth, and gestational hypertension if hormonal exposure continues. Close fetal monitoring recommended. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combined oral contraceptive use. Risk increases with age and amount smoked, especially in women over 35.
| Serious Effects |
["Thrombophlebitis or thromboembolic disorders","History of deep vein thrombosis or pulmonary embolism","Cerebrovascular or coronary artery disease","Known or suspected breast carcinoma","Estrogen-dependent neoplasia","Undiagnosed abnormal genital bleeding","Pregnancy","Active liver disease or benign/malignant liver tumors","Smoking and age >35, especially heavy smoking","Hypersensitivity to any component"]
| Precautions | ["Increased risk of thromboembolic events, especially in smokers over 35","Hepatic neoplasia risk","Gallbladder disease","Carbohydrate and lipid metabolism effects","Elevated blood pressure","Ocular lesions (e.g., retinal thrombosis)","Headache/migraine exacerbation","Unscheduled bleeding/spotting"] |
| Food/Dietary | No significant food interactions. Grapefruit juice may increase ethinyl estradiol levels; avoid excessive consumption. High-fat meals can increase drug absorption but not clinically relevant. Alcohol does not interact directly but may impair adherence. |
Loading safety data…
| Fetal Monitoring |
| Monitor blood pressure, weight, and fetal growth via ultrasound every 4-6 weeks in continuing users. Assess for signs of thromboembolism. Perform serial growth scans if used beyond first trimester. |
| Fertility Effects | Does not impair fertility; normal ovulation returns after discontinuation. May regulate menstrual cycles and improve fertility in conditions like PCOS. |
| Clinical Pearls | AUROVELA 1/20 (norethindrone acetate 1 mg/ethinyl estradiol 20 mcg) is a monophasic oral contraceptive. Advise patients to take at the same time daily to maintain consistent hormone levels. Missed pill protocol: if one pill is missed, take it as soon as remembered; if two or more are missed, use backup contraception for 7 days. Monitor for breakthrough bleeding, especially in the first 3 cycles. Contraindicated in smokers over 35, hypertension, history of thromboembolism, migraine with aura, or liver disease. |
| Patient Advice | Take one tablet daily at the same time, preferably with food to reduce nausea. · If you miss a pill, refer to the package insert for specific instructions; use backup contraception if needed. · Common side effects include nausea, breast tenderness, and breakthrough bleeding; these usually improve after 2-3 cycles. · Do not smoke while taking this medication due to increased risk of blood clots. · This medication does not protect against sexually transmitted infections (STIs). · Contact your healthcare provider if you experience severe headache, chest pain, leg pain/swelling, or vision changes. |