Dosing & Uses
Dosage Forms & Strengths
norelgestromin/ethinyl estradiol
transdermal patch
- Delivers (150mcg/35mcg)/24 hr
Contraception
One patch applied to skin each week x 3 weeks (days 1, 8, & 15), then off for 1 week (days 22-28); repeat cycle
Initial treatment: Apply patch on 1st day of menstruation (day 1); if applied after 1st day, use additional form of contraception for 7 days
Switching from OC: Apply on 1st day of withdrawal bleeding; if applied after 1st day, use additional form of contraception for 7 days
After 1st trimester abortion: Begin treatment immediately; if not started within 5 days, use additional form of contraception for 7 days
Initiating after pregnancy
- Increased risk for venous thromboembolism (VTE) following delivery with combined hormonal contraceptives; risk declines rapidly after 21 days, but does not return to normal until 42 days after delivery
- CDC guidelines recommend waiting 3-6 weeks in postpartum women without additional VTE risks (MMWR July 7, 2011)
- Initiating after vaginal birth: Wait at least 3 weeks
- Initiating after caesarean section birth: Wait at least 6 weeks
- Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives
If Patient Forgets to Change Patch
At start of patch cycle: Apply new patch immediately, count as "day 1" of cycle, use additional form of contraception for 7 days
In middle of patch cycle
- <48 hours: Apply new patch immediately, then next patch on usual "Patch Change Day"
- >48 hours: Apply new patch immediately, count as "day 1" of cycle, use additional form of contraception for 7 days
If Patch Partially or Completely Detached
<24 hours: Reapply to same place, or replace with new patch immediately
>24 hours: Apply new patch immediately, count as "day 1" of cycle
>1 week: Rule out pregnancy before restarting treatment; use additional form of contraception for 7 days
Renal Impairment
Use caution; monitor blood pressure
Hepatic Impairment
Do not administer
Other Information
At end of patch cycle (day 22): Take off patch immediately; apply next patch on usual start of next cycle
Not recommended
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
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
Postmarketing Reports
Dysgeusia
Also see Estradiol combos for details; similar to oral contraceptives
Warnings
Black Box Warnings
Cigarette smoking & risk of cardiovascular disease
- Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
- This risk increases w/ age (>35 yr) & w/ heavy smoking (15 or more cigarettes/day)
- For this reason, hormonal contraceptives, including Ortho Evra patch, should not be used by women who smoke and are 35 years or older
Thromboembolism
- Risk of venous thromboembolism (VTE) among women aged 15-44 who used the Ortho Evra patch compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in 4 U.S. case-control studies using electronic healthcare claims data
- The odds ratios ranged from 1.2-2.2
- One of the studies found a statistically significant increased risk of VTE for current users of Ortho Evra
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
Cautions
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
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)
Pregnancy & Lactation
Pregnancy Category: X
Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ethinylestradiol (EE): reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, & various proteins in target tissues
Norelgestromine: Progestin; inhibits gonadotropin secretion from pituitary; prevents follicular maturation and ovulation, stimulates growth of mammary tissues
Pharmacokinetics
Half-Life: 17 hr (ethinyl estradiol); 28 hr (norelgestromin)
Metabolism: Norgestrel is primary metabolite of norelgestromin
Excretion: Urine, feces
Bioavailability: 60% (ethinyl estradiol)
Protein bound
- Ethinyl estradiol: Extensively bound to serum albumin
- Norelgestromin: Highly bound (>97%) to serum; also bound to albumin but not to SHBG
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
