AUROVELA FE 1/20
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AUROVELA FE 1/20 (AUROVELA FE 1/20).
Combination oral contraceptive containing ethinyl estradiol and norethindrone acetate. Inhibits ovulation by suppressing gonadotropin release (FSH, LH). Increases viscosity of cervical mucus, reducing sperm penetration. Alters endometrial lining to reduce implantation likelihood.
| Metabolism | Ethinyl estradiol undergoes CYP3A4 metabolism and first-pass conjugation; norethindrone acetate is deacetylated to norethindrone, primarily metabolized by CYP3A4 and reduction pathways. |
| Excretion | Renal: ~50-60% as metabolites; fecal: ~40-50% as metabolites; biliary excretion contributes to fecal elimination. |
| Half-life | Norethindrone: 7-8 hours; ethinyl estradiol: 13-14 hours (with interindividual variability). |
| Protein binding | Norethindrone: ~61% bound to albumin and SHBG; ethinyl estradiol: ~97% bound to albumin. |
| Volume of Distribution | Norethindrone: ~2.7 L/kg; ethinyl estradiol: ~1.9 L/kg; distributes into breast milk. |
| Bioavailability | Oral: Norethindrone ~64%; ethinyl estradiol ~45% (first-pass metabolism). |
| Onset of Action | Oral: Contraceptive effect requires 7 days of continuous dosing; maximum effect after 10-14 days. |
| Duration of Action | Contraceptive effect persists for 24 hours; missed dose guidelines apply beyond 24-hour dosing interval. |
| Molecular Weight | 368.58 |
One tablet (1 mg norethindrone acetate, 20 mcg ethinyl estradiol) orally once daily at the same time each day for 21 days, followed by one iron tablet (75 mg ferrous fumarate) orally once daily for 7 days.
| Dosage form | TABLET |
| Renal impairment | No dosage adjustment required for mild to moderate renal impairment. Contraindicated in patients with markedly impaired renal function due to potential fluid retention and estrogen-related adverse effects. |
| Liver impairment | Contraindicated in patients with acute or chronic hepatic dysfunction, including Child-Pugh A, B, or C cirrhosis, due to impaired steroid metabolism. |
| Pediatric use | Post-menarche: same as adult dosing (one tablet daily for 21 days, then iron tablet for 7 days). Not indicated before menarche. |
| Geriatric use | Not indicated for use after menopause. No specific dose adjustment; use lowest effective dose if considered for other indications, but generally avoid due to increased risk of thromboembolism and cardiovascular events. |
| 1st trimester | Avoid use during first trimester due to risk of oral clefts and cardiovascular defects associated with hormonal contraception. |
| 2nd trimester | Avoid use during second trimester; may increase risk of fetal harm including masculinization of female fetuses and other anomalies. |
| 3rd trimester | Avoid use during third trimester; may cause adverse effects on fetal development and neonatal complications. |
Clinical note
Comprehensive clinical and safety monograph for AUROVELA FE 1/20 (AUROVELA FE 1/20).
| Placental transfer | Ethinyl estradiol and norethindrone readily cross the placenta; detectable in fetal tissues. |
| Breastfeeding | Combined hormonal contraceptives are generally not recommended during breastfeeding as they may reduce milk production and pass into breast milk. Ethinyl estradiol and norethindrone are excreted in small amounts; alternative contraception is advised. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combination oral contraceptives. Risk increases with age (>35 years) and number of cigarettes smoked. Women over 35 who smoke should not use this product.
| Serious Effects |
Known or suspected pregnancyThrombophlebitis or thromboembolic disordersHistory of deep vein thrombosis or pulmonary embolismCerebrovascular or coronary artery diseaseKnown or suspected breast cancerEstrogen-dependent neoplasiaUndiagnosed abnormal genital bleedingCholestatic jaundice of pregnancy or jaundice with prior pill useHepatic adenoma or carcinomaMajor surgery with prolonged immobilizationDiabetes mellitus with vascular involvementHeadaches with focal neurological symptomsSmoking and age over 35Hypertension with vascular disease
| Precautions | Increased risk of thromboembolic disorders (DVT, PE, stroke, MI), especially in smokers >35 years. Risk of hepatic neoplasia. Elevated blood pressure. Gallbladder disease. Carbohydrate and lipid effects. Headache. Uterine bleeding irregularities. Discontinue if jaundice, vision loss, or thromboembolic symptoms occur. |
| Food/Dietary |
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| Lactation Rating | L4 - Possibly Hazardous |
| Teratogenic Risk | AUROVELA FE 1/20 (norethindrone acetate/ethinyl estradiol) is contraindicated in pregnancy. First trimester exposure is associated with a slightly increased risk of congenital anomalies, including cardiovascular and limb defects. Second and third trimester exposure may cause fetal harm, including feminization of male fetuses and genitourinary abnormalities. No known risk of miscarriage. |
| Fetal Monitoring | Monitor blood pressure, renal function, and glucose tolerance. If accidental exposure during pregnancy, perform ultrasound for fetal anomalies. No routine monitoring recommended otherwise due to contraindication. |
| Fertility Effects | Suppresses ovulation via inhibition of gonadotropins. May cause endometrial atrophy and cervical mucus thickening. After discontinuation, return to fertility is typically rapid; however, there may be a transient delay in ovulation of up to 2-3 cycles. |
| No significant food interactions. Avoid grapefruit juice as it may increase estrogen levels. Ferrous fumarate absorption is enhanced by vitamin C (e.g., citrus) and decreased by calcium supplements or dairy; take iron tablets separately from high-calcium meals if concerned. Alcohol is not contraindicated but may increase risk of liver toxicity in high doses; limit consumption. |
| Clinical Pearls | AUROVELA FE 1/20 contains norethindrone acetate 1 mg and ethinyl estradiol 20 mcg with ferrous fumarate (iron) in the placebo pills. It is a monophasic oral contraceptive with low estrogen dose; consider for patients needing iron supplementation or those with heavy menstrual bleeding. The ferrous fumarate may cause gastrointestinal upset or dark stools. Breakthrough bleeding is more common with 20 mcg EE pills. Advise consistent dosing at the same time daily to maintain efficacy. Contraindicated in patients with migraine with aura, hypertension (>160/100), or history of thromboembolism. Monitor for signs of DVT/VTE, especially in smokers over 35. |
| Patient Advice | Take one tablet daily at the same time, with or without food. · If you miss a pill, refer to the package leaflet or consult your provider; for missing active pills, take the missed pill as soon as remembered and use backup contraception for 7 days. · The last 7 pills (brown) are iron tablets and should be taken even if you don't have a period; they do not prevent pregnancy. · Common side effects include nausea, breast tenderness, and breakthrough bleeding, especially during the first few cycles. · This pill does not protect against HIV or other sexually transmitted infections; use condoms for STD prevention. · Avoid smoking, especially if over 35, due to increased risk of blood clots. · Ferrous fumarate may cause dark or greenish stools; this is harmless. · Contact your doctor immediately if you experience sudden severe headache, chest pain, leg pain/swelling, or vision changes. |