Classes
DEA Class; Rx
Common Brand Names; Xulane, Ortho Evra (DSC)
- Contraceptives, Transdermal
Description
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
Indications
Indicated for routine contraception.
Contraindications
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
Adverse Effects
- 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
Warnings
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 and Lactation
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
Maximum Dosage
1 patch/week transdermally.
Not indicated.
1 patch/week transdermally.
Not indicated in prepubescent females.
How supplied
Norelgestromin/ethinyl estradiol
transdermal patch
- Delivers (150mcg/35mcg)/24 hr