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norgestimate and estrogen

G03FA13

Forms & Strengths

Oral tablets: Ethinyl Estradiol 0.035 mg / Norgestimate 0.215 mg, 0.2
Oral tablets: Ethinyl Estradiol 0.035 mg / Norgestimate 0.25 mg
Multiphasic 28-day pill packs

Adult Dosing

Contraception: One tablet daily in a 28-day regimen, preferably at the same time each day

Pediatric Dosing

Postmenarchal adolescents: One tablet daily in a 28-day regimen (same as adult dosing)

Indications

Prevention of pregnancy
Treatment of moderate acne vulgaris in females at least 15 years old desiring contraception

Mechanism of Action

Suppression of gonadotropins (LH and FSH), which inhibits ovulation
Alteration of cervical mucus to inhibit sperm penetration
Alteration of the endometrium to reduce implantation potential

Contraindications

Known or suspected pregnancy
High risk of arterial or venous thrombotic diseases (e.g., active DVT/PE, history of CVAD)
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
Cigarette smoking in women over age 35

Adverse Reactions

Venous thromboembolism (DVT, PE)
Arterial thrombosis (stroke, myocardial infarction)
Hypertension
Nausea and abdominal cramping
Breast tenderness and enlargement
Headache or migraine
Weight fluctuations
Breakthrough bleeding or 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
Antiviral agents (e.g., HCV/HIV protease inhibitors and NNRTIs) can significantly alter efficacy
Lamotrigine: Estrogens may decrease serum concentrations, reducing seizure control
Bile acid sequestrants may decrease absorption of oral contraceptives

Curated Content: Needs Vetting Before Put to Clinical Use