AUROVELA 1.5/30
Clinical safety rating
cautionComprehensive clinical and safety monograph for AUROVELA 1.5/30 (AUROVELA 1.5/30).
Combined estrogen-progestin contraceptive: ethinyl estradiol suppresses gonadotropin (FSH, LH) release via negative feedback on pituitary; norethindrone acetate inhibits ovulation by suppressing LH surge, altering cervical mucus and endometrial lining.
| Metabolism | Ethinyl estradiol undergoes hepatic CYP3A4 metabolism. Norethindrone acetate is deacetylated to norethindrone, which is metabolized primarily via reduction and conjugation (CYP3A4 minor role). |
| Excretion | Renal (25% norethindrone metabolites, 5% ethinyl estradiol metabolites) and fecal (60% norethindrone, 30% ethinyl estradiol); <1% unchanged drug in urine. |
| Half-life | Norethindrone: 8-10 hours; Ethinyl estradiol: 13-27 hours. Steady-state achieved within 5-7 days. |
| Protein binding | Norethindrone: 75% bound to albumin and SHBG; Ethinyl estradiol: 95-98% bound to albumin. |
| Volume of Distribution | Norethindrone: 3.5-4.5 L/kg; Ethinyl estradiol: 3-5 L/kg; reflects extensive tissue distribution. |
| Bioavailability | Norethindrone: 65% (first-pass effect); Ethinyl estradiol: 40-50% (first-pass effect). |
| Onset of Action | Oral: 7 days with continuous daily dosing for full contraceptive effect; for estrogenic effects, within 24 hours. |
| Duration of Action | Contraceptive effect maintained with daily dosing; withdrawal bleeding occurs within 2-3 days after last active tablet. |
| Molecular Weight | 340.5 |
| Action Class | Oral Contraceptive; Estrogen/Progestin Combination |
One tablet (1.5 mg norethindrone acetate, 30 mcg ethinyl estradiol) orally once daily at the same time each day for 21 days, followed by 7 days of placebo.
| Dosage form | TABLET |
| Renal impairment | No specific dose adjustment recommended. Use with caution in severe renal impairment (GFR < 30 mL/min) due to potential fluid retention. |
| Liver impairment | Contraindicated in Child-Pugh class B or C (moderate to severe hepatic impairment). For Child-Pugh class A, use with caution, monitor liver function. |
| Pediatric use | Not indicated for use before menarche. Post-menarche: same as adult dosing (one tablet daily). |
| Geriatric use | Not indicated for use in postmenopausal women. |
| 1st trimester | Contraindicated; risk of fetal malformations (e.g., cardiovascular, neural tube defects) due to progestin and estrogen exposure. |
| 2nd trimester | Avoid; potential adverse effects on fetal development and pregnancy outcomes. |
| 3rd trimester | Avoid; may cause fetal harm (e.g., masculinization of female fetuses) and complications during delivery. |
Clinical note
Comprehensive clinical and safety monograph for AUROVELA 1.5/30 (AUROVELA 1.5/30).
| Placental transfer | Both components (norethindrone acetate and ethinyl estradiol) cross the placenta; documented in human studies. |
| Breastfeeding | Excreted in breast milk; may reduce milk production and affect infant hormonal balance. Use only if clearly needed. |
| Lactation Rating | L4 - Possibly Hazardous |
| Teratogenic Risk | AUROVELA 1.5/30 (ethinyl estradiol 30 mcg, levonorgestrel 1.5 mg) is contraindicated in pregnancy. First trimester exposure is not associated with a significant increase in major malformations; however, hormonal contraceptives should be discontinued if pregnancy is suspected. Second and third trimester exposure may increase risks of fetal genital tract abnormalities (e.g., hypospadias with progestins) and potential long-term effects, though data are limited due to contraindication. |
| Fetal Monitoring | If unintentional use during pregnancy, monitor fetal growth and anatomy via ultrasound. In lactating women, monitor infant for jaundice, weight gain, and signs of estrogen/progestin effects. Maternal monitoring includes blood pressure, liver function tests, and glucose tolerance due to hormonal effects. |
| Fertility Effects | AUROVELA 1.5/30 suppresses ovulation via inhibition of gonadotropins. Fertility returns to baseline upon discontinuation; no evidence of permanent impairment. May cause menstrual irregularities (e.g., amenorrhea, spotting) during use. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combined hormonal contraceptives (CHCs). Risk increases with age and number of cigarettes smoked. Women over 35 who smoke should not use CHCs.
| Common Effects | Nausea, Headache, Breast tenderness, Weight changes, Irregular uterine bleeding, Mood changes, Acne |
| Serious Effects | Venous thromboembolism (VTE), Arterial thromboembolism (e.g., stroke, myocardial infarction), Hepatic adenoma or hepatocellular carcinoma, Hypertension, Gallbladder disease, Thrombotic thrombocytopenic purpura (TTP), Hemolytic uremic syndrome (HUS) |
PregnancyHistory of or current venous thromboembolismSignificant liver disease (e.g., acute hepatitis, decompensated cirrhosis, liver tumors)Known or suspected malignant neoplasms (e.g., breast cancer, endometrial cancer)Undiagnosed abnormal genital bleedingHypersensitivity to any componentUse with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir
| Precautions | Increased risk of thromboembolic events, myocardial infarction, stroke, hepatic neoplasia, gallbladder disease, hypertension. Should be discontinued if jaundice, visual disturbances, or migraine develops. Monitor blood pressure, glucose, and lipids in at-risk patients. |
| Food/Dietary | Grapefruit juice may increase estrogen levels; avoid large quantities. No other significant food interactions. Take with food if nausea occurs. |
| Clinical Pearls | AUROVELA 1.5/30 is a monophasic oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg. It is indicated for contraception and management of menstrual disorders. Note increased thrombotic risk in smokers over 35. Adjust dosing if patient is on enzyme-inducing antiepileptics or rifampin. Breakthrough bleeding common in first 3 cycles. |
| Patient Advice | Take one tablet daily at same time, with or without food. · If missed pill, follow package instructions; use backup contraception if needed. · Common side effects: nausea, breast tenderness, breakthrough bleeding; usually subside. · Monitor for symptoms of thrombosis: leg pain, swelling, chest pain, shortness of breath. · No protection against STIs; use condoms for prevention. · Inform your doctor if you smoke, have migraines with aura, or history of blood clots. |
Loading safety data…