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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
chlormadinone and ethinylestradiol
G03AA15
Forms & Strengths
- Tablet: chlormadinone acetate 2 mg / ethinylestradiol 0.03 mg
Adult Dosing
- Oral: 1 tablet daily for 21 consecutive days, followed by a 7-day pill-free interval
- Start on day 1 of the natural menstrual cycle
Pediatric Dosing
- Not indicated before menarche
- Adolescents post-menarche: same as adult dosing
Indications
- Oral contraception
- Treatment of acne vulgaris in women desiring contraception
Mechanism of Action
- Combination of an antiandrogenic progestin (chlormadinone acetate) and an estrogen (ethinylestradiol)
- Inhibits ovulation primarily via suppression of hypothalamic gonadotropins (LH and FSH)
- Alters cervical mucus viscosity to impede sperm penetration and changes endometrium to inhibit implantation
Contraindications
- Presence or risk of venous thromboembolism (VTE)
- Presence or risk of arterial thromboembolism (ATE)
- Known or suspected sex-steroid sensitive malignancies
- Severe hepatic disease or tumors
- Undiagnosed abnormal vaginal bleeding
- Hypersensitivity to active substances or excipients
- Concomitant use with hepatitis C virus (HCV) drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir
Adverse Reactions
- Common: Headache, nausea, breast tenderness, breakthrough bleeding, spotting
- Less common: Libido changes, depressed mood, migraine, vomiting, acne, dysmenorrhea
- Serious: Venous and arterial thromboembolism, myocardial infarction, stroke, hepatic adenomas, hypertension
Drug Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) decrease contraceptive efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase plasma concentrations of the hormones
- Antidiabetic agents: Combined oral contraceptives may affect glucose tolerance; dosage adjustments of insulin or oral antidiabetics may be required
- Lamotrigine: Estrogen-containing contraceptives decrease lamotrigine plasma concentrations, risking loss of seizure control
Curated Content: Needs Vetting Before Put to Clinical Use