Norgestimate/​Ethinyl Estradiol

DEA Class; Rx

Common Brand Names; Mononessa, Ortho Cyclen-28, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Estarylla, Tri-Estarylla, Tri-Lo-Estarylla, Mili, Mono-Linyah, Tri-Linyah, Previfem, Sprintec 28, TriCyclen, Tri-Lo Sprintec, Tri-Mili, Tri-Lo-Mili, Trinessa, TriNessa Lo, TriPrevifem, TriSprintec, Femynor, TriFemynor, Tri-Lo-Marzia

Indicated for routine contraception.

Documented hypersensitivity

Active or history of breast cancer

Arterial thromboembolic disease (stroke, myocardial infarction [MI]), thrombophlebitis, DVT/pulmonary embolism (PE), thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver disease, liver tumors

Undiagnosed abnormal uterine bleeding

Uncontrolled hypertension (ie, persistent BP values >160 mm Hg systolic or >100 mg Hg diastolic)

Diabetes mellitus with vascular involvement

Jaundice with previous oral contraceptive use

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

Women > 35 years who smoke

Cerebrovascular and/or coronary artery disease, disease, headaches with focal neurological symptoms, migraine headaches with auro or migraine headaches if >35 years of age

Use caution in family history of breast cancer and or DVT/PE, current or previous depression, endometriosis, diabetes mellitus, hypertension, bone mineral density changes, renal or hepatic impairment, bone metabolic disease, systemic lupus erythematosus (SLE), conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

Monitor prediabetic and diabetic women on therapy; consider alternate contraceptive method for women with uncontrolled dyslipidemia

Headache: Evaluate significant change in headaches and discontinue therapy if indicated

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception

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

Discontinue 4 weeks before major surgery or prolonged immobilization

Patients on warfarin or oral anticoagulants: Increase in anticoagulant dosage may be warranted

Some studies link oral contraceptive use with increased risk of breast cancer, whereas others do not; risk depends on conditions where naturally high hormone levels persist for long periods, including early-onset menstruation (age <12 years), late-onset menopause (age >55 years), first child after age 30 years, nulliparity

Increased risk of cervical cancer with oral contraceptive use, however, human papillomavirus (HPV) remains primary risk factor for this cancer

Long-term (≥5years) use of oral contraceptives may be associated with increased risk

Increased risk of liver cancer with oral contraceptive use; risk increases with duration of use

Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen

Chloasma associated with combination hormonal contraceptives, as well as pregnancy and sun exposure; avoid sun exposure or ultraviolet radiation during therapy

Risk of cholestasis increased with prior history of cholestasis with prior contraceptive use or previous cholestasis of pregnancy

Combination hormonal contraceptives may adversely affect lipid levels; consider alternative contraception for women with uncontrolled dyslipidemia

Retinal vascular thrombosis reported in patients receiving estrogens; discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued

Pregnancy category: X

Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality or quantity of milk; may be prudent to use other forms of birth control until full weaning (American Academy of Pediatrics committee states that agent is compatible with nursing); not recommended