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GENITO URINARY SYSTEM AND SEX HORMONES › SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE › Progestogens and estrogens, fixed combinations
levonorgestrel and ethinylestradiol
G03AA07
Forms & Strengths
- Oral tablets: Levonorgestrel 0.10 mg / Ethinyl Estradiol 0.02 mg
- Oral tablets: Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg
- Oral tablets: Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg (28-day packs with 7 inactive pills)
Adult Dosing
- Contraception: One tablet daily taken orally at the same time every day for 21 consecutive days, followed by 7 days of inactive or no pills (28-day regimen)
- Continuous/Extended regimens: One tablet daily without a pill-free interval, per specific product labeling
Pediatric Dosing
- Post-menarchal adolescents: One tablet daily matching adult dosing regimen
- Safety and efficacy established only after menarche; pre-pubertal use not indicated
Indications
- Prevention of pregnancy
- Treatment of moderate acne vulgaris in females at least 15 years of age desiring contraception
- Management of primary dysmenorrhea and premenstrual symptoms
Mechanism of Action
- Suppression of gonadotropins (FSH and LH), thereby inhibiting ovulation
- Alteration of cervical mucus to impede sperm penetration and transport
- Modification of the endometrium to reduce the likelihood of implantation
Contraindications
- A known or suspected pregnancy
- History of thrombophlebitis, thromboembolic disorders, or cerebral vascular disease
- Active liver disease or severe hepatic impairment
- Known or suspected carcinoma of the breast or estrogen-dependent neoplasia
- Undiagnosed abnormal uterine bleeding
- Hypersensitivity to any component of the product
- Smoking in women over 35 years of age
Adverse Reactions
- Venous and arterial thromboembolism, myocardial infarction, stroke
- Hypertension
- Irregular uterine bleeding, amenorrhea, breast tenderness
- Nausea, vomiting, abdominal cramps, bloating
- Headache, migraine, mood changes, depression
- Weight changes, melasma, fluid retention
Drug Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) decrease contraceptive efficacy and increase breakthrough bleeding
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase plasma concentrations of ethinyl estradiol
- Lamotrigine: Estrogen-containing products decrease lamotrigine concentrations, potentially reducing seizure control
- Antidiabetic agents: Hormonal contraceptives may impair glucose tolerance, requiring dosage adjustments of insulin or oral hypoglycemics
Curated Content: Needs Vetting Before Put to Clinical Use