Norelgestromin/Ethinyl Estradiol

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

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