Norgestrel/​Ethinyl Estradiol

DEA Class; Rx

Common Brand Names; Cryselle, Low-Ogestrel, Elinest, Ogestrel

Indicated for routine contraception.

Documented hypersensitivity

Active or history of breast cancer

Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Carcinoma of the endometrium

Liver disease, liver tumors

Undiagnosed abnormal vaginal bleeding

Uncontrolled hypertension

Cerebral vascular or coronary artery disease

Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use

Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

• Edema
• Weakness
• Amenorrhea
• Breakthrough bleeding
• Change in menstrual flow
• Spotting
• Anorexia
• DVT
• Thrombophlebitis
• Depression
• Dizziness
• Headache
• Nervousness
• Somnolence
• Breast tenderness
• Galactorrhea
• Abdominal pain
• Nausea
• Vomiting
• Change in weight
• Cholestatic jaundice

Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

Discontinue 4 week before major surgery or prolonged immobilization. Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

May experience spotting, amenorrhea, and unscheduled bleeding, especially during first 3 months of therapy; evaluate unscheduled or breakthrough bleeding that persists or occurs after regular cycles to rule out malignancy or pregnancy; after discontinuing OCP, may experience oligomenorrhea or amenorrhea

Sun exposure, combination of hormonal contraceptive, and pregnancy may trigger chloasma; patients should avoid sun exposure or ultraviolet radiation if susceptible to chloasma or at risk

Increased risk of cholestasis associated with history of cholestasis with prior OCP use or prior cholestasis of pregnancy

Discontinue use and evaluate for retinal thrombosis if unexplained loss of vision, papilledema, proptosis, or diplopia occur

Combination hormonal therapy may adversely affect lipid levels, including serum triglycerides; risk of pancreatitis may increase in patients with hypertriglyceridemia or family history of hypertriglyceridemia; in uncontrolled hyperlipidemia, consider alternative contraception

Use of combination hormonal contraceptives is associated with hepatic adenomas; fatal intra-abdominal hemorrhage may occur with rupture; rare hepatocellular carcinoma associated with long term use of OCP

Therapy not recommended in patients with acute viral hepatitis or during a flare; severity of cirrhotic fibrosis or hepatocellular carcinoma has not been shown to increase with continued use of hormonal combination therapy or to trigger liver failure or hepatic dysfunction

Risk of cardiovascular disease may increase in patients at risk, including high LDL, low HDL, high triglycerides, patients who smoke, or with diabetes; use caution

Pregnancy

There is little or no increased risk of birth defects in children of females who inadvertently use COCs during early pregnancy

Discontinue use if pregnancy is confirmed

Contraceptive hormones and/or metabolites are present in human milk in small amounts; effects of therapy on breastfed child is unknown; COCs can reduce milk production in lactating women