Comparative Pharmacology
Head-to-head clinical analysis: AUROVELA FE 1 5 30 versus AUROVELA FE 1 20.
Peer-Reviewed Evidence
Head-to-head clinical analysis: AUROVELA FE 1 5 30 versus AUROVELA FE 1 20.
AUROVELA FE 1.5/30 vs AUROVELA FE 1/20
Head-to-head clinical comparison of therapeutic indices and safety profiles.
Combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate is a progestin that suppresses gonadotropin release, inhibiting ovulation; ethinyl estradiol is an estrogen that provides feedback inhibition of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), preventing follicular development and ovulation. Additionally, it causes changes in cervical mucus (increased viscosity) and endometrium (reduced receptivity).
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.
Prevention of pregnancy (FDA-approved)Treatment of moderate acne vulgaris in females at least 15 years of age who have no known contraindications to oral contraceptive therapy and have achieved menarche (off-label but common use)Management of menstrual disorders (off-label): dysmenorrhea, menorrhagia, irregular bleedingHormonal contraception in patients with iron deficiency anemia (due to iron supplementation in formulation)
Prevention of pregnancyTreatment of moderate acne vulgaris in females ≥15 years old who have reached menarche and desire contraceptionTreatment of heavy menstrual bleeding in women without organic pathology
One tablet orally once daily at the same time each day for 28 consecutive days.
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.
None Documented
None Documented
Norethindrone: 5-14 hours (terminal); Ethinyl estradiol: 10-20 hours (terminal). Steady-state achieved within 5-7 days; contraceptive efficacy maintained with daily dosing.
Norethindrone: 7-8 hours; ethinyl estradiol: 13-14 hours (with interindividual variability).
Norethindrone acetate is metabolized primarily in the liver via reduction and conjugation (sulfation and glucuronidation). It is a prodrug, rapidly hydrolyzed to norethindrone. Ethinyl estradiol is metabolized via CYP3A4 in the liver, undergoing hydroxylation, methylation, and conjugation (glucuronidation and sulfation). Both undergo enterohepatic recirculation.
Ethinyl estradiol undergoes CYP3A4 metabolism and first-pass conjugation; norethindrone acetate is deacetylated to norethindrone, primarily metabolized by CYP3A4 and reduction pathways.
Renal: ~50-60% as metabolites, <10% unchanged; Fecal: ~40-50% via bile; Ethinyl estradiol undergoes enterohepatic recirculation.
Renal: ~50-60% as metabolites; fecal: ~40-50% as metabolites; biliary excretion contributes to fecal elimination.
Norethindrone: ~97% (albumin and SHBG); Ethinyl estradiol: ~97-98% (albumin, not SHBG).
Norethindrone: ~61% bound to albumin and SHBG; ethinyl estradiol: ~97% bound to albumin.
Norethindrone: 2-5 L/kg (extensive tissue distribution); Ethinyl estradiol: 2-4 L/kg (distributes into breast milk and body fat).
Norethindrone: ~2.7 L/kg; ethinyl estradiol: ~1.9 L/kg; distributes into breast milk.
Oral: Norethindrone ~64% (first-pass effect); Ethinyl estradiol ~40-45% (extensive first-pass metabolism).
Oral: Norethindrone ~64%; ethinyl estradiol ~45% (first-pass metabolism).
No dose adjustment required for mild to moderate renal impairment. Not studied in severe renal impairment (GFR <30 mL/min/1.73 m²); use is not recommended.
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.
Contraindicated in severe hepatic disease (Child-Pugh class C). Use with caution and monitor liver function in mild to moderate impairment (Child-Pugh A/B); consider alternative methods if liver function deteriorates.
Contraindicated in patients with acute or chronic hepatic dysfunction, including Child-Pugh A, B, or C cirrhosis, due to impaired steroid metabolism.
Not indicated for use before menarche.
Post-menarche: same as adult dosing (one tablet daily for 21 days, then iron tablet for 7 days). Not indicated before menarche.
Not indicated for use in postmenopausal women. No specific studies in elderly; consider age-related risks of thromboembolism and cardiovascular disease.
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.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, especially in women over 35 years of age, and with the number of cigarettes smoked. Women who use combination oral contraceptives should be strongly advised not to smoke.
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.
["Thrombotic disorders: risk of venous thromboembolism, arterial thromboembolism, stroke, myocardial infarction; increased in smokers, obese, or those with thrombogenic mutations","Hepatic neoplasia: rare cases of benign and malignant liver tumors reported","Ocular effects: retinal thrombosis, papilledema, optic neuritis","Cardiovascular: hypertension, lipid effects, increased risk in women with hypertension or hyperlipidemia","Carbohydrate metabolism: impaired glucose tolerance, increased insulin resistance","Headache/migraine: discontinue if new or worsening migraine or severe headache","Bleeding irregularities: breakthrough bleeding, spotting, amenorrhea","Gallbladder disease: increased risk","Depression: can exacerbate","Hereditary angioedema: may trigger or worsen","Chloasma: may cause melasma, exacerbated by sun exposure","Iron supplementation: caution in hemochromatosis or iron overload disorders","Dental/gingival: gingivitis","Laboratory tests: may affect thyroid, sex hormone-binding globulin, coagulation factors"]
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.
["Current or past history of thrombophlebitis or venous thromboembolism","Cerebrovascular or coronary artery disease (current or history)","Known or suspected pregnancy","Undiagnosed abnormal uterine bleeding","Known or suspected estrogen-dependent neoplasia (e.g., breast cancer, endometrial cancer)","Active liver disease, impaired liver function, or benign/malignant liver tumors (current or history)","Hypersensitivity to any component of the product","Women over 35 years of age who smoke cigarettes","Uncontrolled hypertension (blood pressure >160/100 mmHg)","Migraine with aura at any age","Diabetes mellitus with vascular involvement","Major surgery with prolonged immobilization","Current or history of breast cancer (confirmed or suspected)"]
Thrombophlebitis or thromboembolic disorders. History of DVT/PE. Cerebrovascular or coronary artery disease. Known or suspected breast cancer. Estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Known or suspected pregnancy. Active liver disease or hepatic adenoma. Hypersensitivity to components. Smokers >35 years.
Data Pending Review
Data Pending Review
Grapefruit and grapefruit juice may increase ethinyl estradiol levels; avoid large quantities. No other significant food interactions. Take with food or milk to reduce gastrointestinal upset if needed.
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.
Contraindicated in pregnancy. Use during first trimester associated with oral clefts and cardiac defects; second and third trimester exposure linked to feminization of male fetuses and other anomalies due to progestin effects. Increased risk of ectopic pregnancy. On-label indications exclude pregnancy use.
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.
Excreted in breast milk; M/P ratio unknown. May reduce milk production and alter composition. Use only if benefits outweigh risks, with monitoring for infant jaundice and weight gain. Consider alternative contraception during breastfeeding.
Small amounts of contraceptive steroids and/or metabolites are excreted in breast milk. Milk-to-plasma (M/P) ratio: not established. Use may reduce milk production and composition; if possible, use alternative contraception. AAP considers it compatible with breastfeeding but caution advised.
Not applicable; drug is contraindicated in pregnancy. No dose adjustments recommended as therapy should be discontinued immediately if pregnancy occurs.
No dose adjustment is indicated as the drug is contraindicated in pregnancy. Pharmacokinetic changes (e.g., increased volume of distribution, altered hepatic metabolism) may require dose adjustment if inadvertently used, but no established recommendations.
Category C
Category C
AUROVELA FE 1.5/30 is a combined oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg. It contains ferrous fumarate as an iron supplement in the placebo pills. Patients with a history of venous thromboembolism, thrombogenic mutations, or estrogen-sensitive malignancies should not use this medication. Baseline blood pressure, lipid profile, and liver function tests are recommended. Counsel patients to take at the same time daily to maintain efficacy. Consider drug interactions with antibiotics, anticonvulsants, and St. John's Wort which may reduce contraceptive effectiveness.
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.
Take one tablet daily at the same time each day, with or without food.Swallow tablets whole; do not crush or chew.Missed dose management: if missed by less than 12 hours, take it as soon as remembered; if more than 12 hours, skip the missed dose and continue with next tablet; use back-up contraception if multiple doses missed.Common side effects include nausea, breast tenderness, weight changes, and breakthrough bleeding; these may improve after 2-3 cycles.Seek immediate medical attention if you experience leg pain/swelling, chest pain, shortness of breath, severe headache, vision changes, or jaundice.Does not protect against sexually transmitted infections (STIs); use condoms for STI prevention.Inform your healthcare provider of all medications, including over-the-counter drugs and herbal supplements.Continue taking the iron-containing placebo tablets during the placebo week; do not skip.
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.