Closely monitor these medications and consider alternative medications in case of potential drug interactions.verapamilMonitor Closely (1)verapamil will increase the level or effect of norgestrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong or moderate CYP3A4 inhibitors may increase systemic concentration of norgestrel, which may increase risk for adverse effects voriconazoleMonitor Closely (1)voriconazole will increase the level or effect of norgestrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong or moderate CYP3A4 inhibitors may increase systemic concentration of norgestrel, which may increase risk for adverse effects voxelotorMonitor Closely (1)voxelotor will increase the level or effect of norgestrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Strong or moderate CYP3A4 inhibitors may increase systemic concentration of norgestrel, which may increase risk for adverse effects Frequency Not Defined Irregular bleeding Headaches Dizziness Nausea Increased appetite Abdominal pain Cramps or bloating Contraindications Known or suspected pregnancy Known or suspected breast cancer Undiagnosed abnormal genital bleeding Hypersensitivity to norgestrel or excipients Benign or malignant liver tumors Acute liver disease Cautions Cigarette smoking greatly increases the risk of suffering heart attacks and strokes; advise females who use oral contraceptives not to smoke Risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism Remain alert to the earliest manifestation of symptoms of any serious disease and discontinue therapy when appropriate Alert patients of the possibility of an ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle Irregular menstrual patterns are common among women using progestin-only oral contraceptives; if bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out; if prolonged amenorrhea occurs, evaluate if patient is pregnant Increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use, has been reported; women with breast cancer should not use oral contraceptives because the role of female hormone in breast cancer has not been fully determined Benign hepatic adenomas are associated with combined oral contraceptive use Allergic reactions Contains FD&C yellow No.5 (tartrazine) as a color additive People allergic to aspirin often have a tartrazine allergy too Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin erythema, rash, or blisters Discontinue if allergic reaction occurs and promptly seek medical attention Drug interaction overview Norgestrel is a major CYP3A4 substrate Strong or moderate CYP3A4 inhibitors Caution/monitor Strong or moderate CYP3A4 inhibitors may increase systemic concentration of norgestrel, which may increase risk for adverse effects Strong CYP3A4 inducers Consider therapy modification Strong CYP3A4 inducers: Contraceptive failure is possible owing to decreased serum concentration of norgestrel Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing the strong CYP3A4 inducer to ensure contraceptive reliability Moderate CYP3A4 inducers may decrease progestin concentration; consider use of additional barrier methods Laboratory tests The following endocrine tests may be affected by progestin-only oral contraceptive use: Sex hormone-binding globulin concentrations may be decreased Thyroxine concentrations may be decreased, owing to a decrease in thyroid-binding globulin Pregnancy Contraindicated for known or suspected pregnancy Advise patients of the importance of ruling out suspected pregnancy before initiating any hormonal contraceptive use Limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins Few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects Lactation Small amounts of progestin pass into the breast milk, resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma According to the LactMed database, progestin-only contraceptives (eg, norgestrel) are considered the hormonal contraceptives of choice during lactation Very rarely, adverse effects in the infant/child have been reported, including jaundice Pregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle luteinizing hormone and follicle-stimulating hormone peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium Oral Administration Take 1 tablet at the same time every day; take even when bleeding or spotting Do NOT use as an emergency contraceptive Continue to see healthcare provider for routine healthcare visits Use a condom or another barrier method if taking tablet >3 hr late or missing a tablet on 1 or more days Missed or vomited dose Missed tablet by ≤3 hr Take 1 tablet immediately and go back to usual schedule Missed tablet by >3 hr or missed ≥1 tablet Take 1 tablet immediately, as soon as remembered; then go back to usual schedule This may mean taking 2 tablets in 1 day Use a condom (or another barrier method) during intercourse for next 48 hr after restarting norgestrel Instruct patient to take a pregnancy test or contact physician if menses is late after missing any tablets in the past month Vomiting or severe diarrhea within 4 hr of dose Use a condom (or another barrier method) during intercourse for next 48 hr On the next day, take daily tablet at usual time Storage Store at 20-25ºC (68-77ºF) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print