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Norelgestromin/Ethinyl Estradiol

    Brands

    DEA Class; Rx

    Common Brand Names; Xulane, Ortho Evra (DSC)

    • Contraceptives, Transdermal

    Combined hormonal contraceptive transdermal patch containing ethinyl estradiol and norelgestromin, a progestin of low androgenic and negligible estrogenic activity
    Patch is worn for 1 week and replaced weekly for 3 consecutive weeks, the 4th week is ‘patch free’
    Used for routine contraception in adolescent and adult premenopausal females
    All combined hormonal contraceptives contain a boxed warning regarding the increased risk for thromboembolism in women who smoke; the higher estrogen exposure with this patch vs. oral contraceptives may increase thromboembolic risk

    Indicated for routine contraception.

    For the treatment of severe acne vulgaris† related to sebum overproduction in females who have no known contraindications to hormonal contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
    For the treatment or adjuvant treatment of amenorrhea, abnormal uterine bleeding (dysfunctional uterine bleeding), hirsutism, hypermenorrhea, or polycystic ovary syndrome related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to hormonal contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition.
    For the treatment of endometriosis† to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to hormonal contraceptives, have achieved menarche and who desire contraception.

    Documented hypersensitivity

    Active or history of breast cancer

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

    Estrogen-dependent neoplasia

    Liver disease, liver tumors

    Undiagnosed abnormal vaginal bleeding

    Uncontrolled hypertension

    Diabetes mellitus with vascular involvement

    Jaundice with prior oral contraceptive use

    • Emotional liability
    • Headache
    • Abdominal pains
    • Nausea
    • Breast symptoms
    • Menstrual cramps
    • Applicaiton site reaction
    • Arterial/venous thromboembolism
    • Hypertension
    • Myocardial infarct
    • Cerebral hemorrhage
    • Gallbladder dz
    • Hepatic adenomas
    • Dysgeusia
    • Also see Estradiol combos for details; similar to oral contraceptives

    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, significang 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)

    Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; woman’s risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

    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

    Risk of venous thromboembolism (VTE) highest in first year of use; risk may increase when combined hormonal contraceptive re-started after a break in use of 4 weeks or longer

    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

    Adults

    1 patch/week transdermally.

    Elderly

    Not indicated.

    Adolescents

    1 patch/week transdermally.

    Children

    Not indicated in prepubescent females.

    Norelgestromin/ethinyl estradiol

    transdermal patch

    • Delivers (150mcg/35mcg)/24 hr