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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
norgestimate and ethinylestradiol
G03AA11
Forms & Strengths
- Oral tablets: Norgestimate 0.18 mg / Ethinyl estradiol 0.035 mg
- Oral tablets: Norgestimate 0.215 mg / Ethinyl estradiol 0.035 mg
- Oral tablets: Norgestimate 0.25 mg / Ethinyl estradiol 0.035 mg
- Oral tablets: Norgestimate 0.18 mg / Ethinyl estradiol 0.025 mg
- Multiphasic and monophasic 28-day pack configurations
Adult Dosing
- Contraception: One tablet daily taken orally at the same time each day for 28 consecutive days per cycle
- Missed dose (1 pill): Take as soon as remembered, then continue regular schedule
- Missed dose (2+ pills, weeks 1-2): Take 2 pills daily for 2 days, then resume 1 pill daily; use backup contraception for 7 days
Pediatric Dosing
- Post-menarchal adolescents (age <18): 1 tablet daily, same as adult dosing regimen
- Safety and efficacy established only after menarche
Indications
- Prevention of pregnancy
- Treatment of moderate acne vulgaris in females at least 15 years of age desiring contraception
Mechanism of Action
- Suppression of gonadotropins (LH and FSH) inhibiting ovulation
- Alteration of cervical mucus to impede sperm penetration
- Modification of the endometrium to reduce the likelihood of implantation
Contraindications
- Known or suspected pregnancy
- High risk of arterial or venous thrombotic diseases (history of DVT, PE, stroke, or CAD)
- Breast cancer or other estrogen- or progestin-sensitive cancer
- Liver tumors, acute hepatitis, or severe liver cirrhosis
- Undiagnosed abnormal uterine bleeding
- Hypersensitivity to any component of the product
- Hepatitis C virus combination drug regimen containing ombitasvir/paritaprevir/ritonavir
Adverse Reactions
- Venous thromboembolism (DVT, pulmonary embolism)
- Arterial thrombosis (stroke, myocardial infarction)
- Hypertension
- Nausea and abdominal cramping
- Breast tenderness and enlargement
- Headache and migraine
- Weight fluctuations
- Breakthrough bleeding and amenorrhea
- Melasma
Drug Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) decrease contraceptive efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, fluconazole) may increase hormone exposure
- Lamotrigine: Estrogen-containing products decrease serum concentrations, reducing seizure control
- Bile acid sequestrants (e.g., colesevelam) decrease absorption of ethinyl estradiol
- Antidiabetic agents: Hormonal contraceptives may impair glucose tolerance, requiring dosage adjustments
Curated Content: Needs Vetting Before Put to Clinical Use