or intracyclic bleeding and spotting may occur, especially during first 3 months of therapy; missed periods may also occur occasionally; evaluate and rule out malignancy if irregular or unresolving vaginal bleeding occurs There are, possible risks that may be associated with use of progestins with estrogens compared to estrogen-alone regimens, including a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (e.g., lowering HDL, raising LDL), and impairment of glucose tolerance Risk of ovarian or endometrial cancer decreased in women using combination hormonal contraceptives May increase risk of gallbladder disease or may worsen gallbladder disease Use of combination hormonal contraceptives associated with hepatic adenomas; rupture may cause fatal intra-abdominal hemorrhage; long term use may be associated with increased risk of hepatocellular carcinoma Estrogens may induce or exacerbate symptoms in women with hereditary angioedema Risk of hypertension may be increased with age, dose, and duration of use; not for use in women with hypertension oand vascular disease Use of combination hormonal contraceptives not recommended in women with complicated organ transplant; medical complications reported Pregnancy There is no use for contraception in pregnancy; this drug should be discontinued during pregnancy; epidemiologic studies and meta-analyses have not found increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to CHCs before conception or during early pregnancy Lactation Contraceptive hormones and/or metabolites are present in human milk; CHCs can reduce milk production in breastfeeding females; this reduction can occur at any time but is less likely to occur once breastfeeding is well-established When possible, advise nursing female to use other forms of contraception until she discontinues breast-feeding; consider developmental and health benefits of breast-feeding along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from this drug from underlying maternal conditionPregnancy 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 Ethinyl estradiol: Reduces release of luteinizing hormone-releasing hormone (LHRH) from hypothalamus; reduces release of gonadotropin from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues Norgestimate: Inhibits secretion of gonadotropin from pituitary; prevents follicular maturation and ovulation; stimulates growth of mammary tissues Absorption Peak plasma time: 2 hr Distribution Protein bound: >97% (ethinyl estradiol) Metabolism Metabolized in liver by CYP3A4 to estriol, estrone (ethinyl estradiol) Elimination Half-life: Ethinyl estradiol, 10-16 hr; norgestimate, 18-25 hr; norgestrel, 38-45 hr Excretion (ethinyl estradiol): Urine as conjugates; most estrogens are also excreted in bile and undergo enterohepatic recycling Excretion (norgestimate): Urine (47%) and feces (37%) as metabolites No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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