Adult Dosing
Contraception (4-wk cycle)
- Apply 1 patch ([ethinyl estradiol 0.02 mg/norelgestromin 0.15 mg]/24 hrs) qwk x 3 wks, followed by 1 wk patch-free interval
- Apply on day 1 of menstrual cycle or first Sunday after the onset of menses
- Start subsequent courses on the day after 7 days patch-free interval
Notes:- Every new patch should be applied on the same day each week; one patch should be worn at a time and the old patch must be removed prior to applying the new patch
- To be applied on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing; rotate application sites
- The patch should not be cut, damaged, or altered in any way
- If applied on the first Sunday after the onset of menstrual period, use another nonhormonal back-up method of contraception until after the first 7 consecutive days of starting
- There should not be more than a 7-day patch-free interval between dosing cycles
- May be started 4 wks postpartum in women who elect not to breastfeed or >6 wks postpartum if breastfeeding
Pediatric Dosing
Contraception (postpubertal adolescents) (4-wk cycle)
- Apply 1 patch ([ethinyl estradiol 0.02 mg/norelgestromin 0.15 mg]/24 hrs) qwk x 3 wks, followed by 1 wk patch-free interval
- Apply on day 1 of menstrual cycle or first Sunday after the onset of menses
- Start subsequent courses on the day after 7 days patch-free interval
Notes:- Not indicated before menarche
- Every new patch should be applied on the same day each week; one patch should be worn at a time and the old patch must be removed prior to applying the new patch
- To be applied on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing; rotate application sites
- The patch should not be cut, damaged, or altered in any way
- If applied on the first Sunday after the onset of menstrual period, use another nonhormonal back-up method of contraception until after the first 7 consecutive days of starting
- There should not be more than a 7-day patch-free interval between dosing cycles
- May be started 4 wks postpartum in women who elect not to breastfeed or >6 wks postpartum if breastfeeding
[Outline]
See Supplemental Patient Information
- Cigarette smokers are more prone to risk of serious cardiovascular side effects from combination hormonal contraceptive use. Advise women who use contraceptives to avoid smoking [US Black Box Warning]
- The pharmacokinetic (PK) profile for combination transdermal contraceptives is different from that of oral contraceptives in that it has a higher steady state concentrations and lower peak concentrations [US Black Box Warning]
- Increased risk of VTE has been reported among women aged 15-44 yrs who used combination transdermal contraceptives compared to women who used oral contraceptives containing 30-35 mcg of EE and either levonorgestrel or norgestimate [US Black Box Warning]
- Increased risk of several serious conditions such as MI, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease has been associated with the therapy. Risk of morbidity and mortality markedly increases in the presence of underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes
- Hormonal contraceptives may potentiate the effects of well-known risk factors such as hypertension, diabetes, hyperlipidemias, age and obesity; these risk factors have been associated with an increased risk of heart disease. Use cautiously in women with cardiovascular disease risk factors
- Increased risk of thromboembolic and thrombotic disease has been reported with the use of combination hormonal contraceptives; risk of post-operative thromboembolic complications has been reported with the use of these contraceptives. Discontinue use at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization; initiate use not earlier than 4-6 weeks after delivery in women electing not to breastfeed
- Combination contraceptives may increase the risk of cerebrovascular events such as thrombotic and hemorrhagic strokes; this risk is greatest among older (>35 yrs) and hypertensive women who also smoke
- Decrease in serum HDL has been associated with an increased risk of ischemic heart disease. As progestins decrease serum HDL and estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogen used in the contraceptives
- Individualize dosage in a way that it contains the least amount of estrogen and progestogen that is compatible with a low failure rate; new users should be started on preparations containing the lowest estrogen content producing satisfactory results
- Prolonged use of combination contraceptives containing 50 mcg or higher estrogens may cause increased risk of vascular diseases
- Combination contraceptives may increase the risk of breast and cervical cancer. Discontinuation of combined hormonal contraceptive decreases this risk. Avoid use in females with known or suspected carcinoma of the breast or personal history of breast cancer
- Rarely, fatal benign hepatic adenomas have been reported with therapy use. Rupture of these benign, hepatic adenomas may cause intra-abdominal hemorrhage leading to death
- Hormonal contraceptives may cause retinal thrombosis leading to partial or complete loss of vision. Discontinue the drug if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions and initiate appropriate diagnostic and therapeutic measures
- Do not use during pregnancy to treat threatened or habitual abortion
- Combination contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women
- Decrease in glucose tolerance has been reported in some patients using hormonal contraceptives. Carefully monitor prediabetic and diabetic women taking combination hormonal contraceptives
- Changes in serum triglycerides and lipoprotein levels have been reported with hormonal contraceptives
- Hypertension may occur during therapy; encourage women with a history of hypertension or hypertension-related diseases, or renal disease to use another method of contraception. Closely monitor hypertensive women electing to use hormonal contraceptives; discontinue use in women with significant elevation of blood pressure
- Discontinue therapy on onset or exacerbation of migraine, development of headache with a new pattern that is recurrent, persistent or severe
- Bleeding irregularities such as breakthrough bleeding and spotting may occur, especially during the first 3 months of hormonal contraceptive use. Consider non-hormonal causes and initiate adequate diagnostic measures to rule out malignancy/pregnancy in the event of breakthrough bleeding or any abnormal vaginal bleeding
- Contraceptive failures can cause ectopic as well as intrauterine pregnancy
- Counsel the patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Consider physical examination and follow up in relevance to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and perform relevant laboratory tests in all the women taking hormonal contraceptive
- Carefully monitor women with a strong family history of breast cancer or having breast nodules
- Closely monitor women who are being treated for hyperlipidemia. Consider nonhormonal contraception in women with uncontrolled dyslipidemia
- Hormonal contraceptives may be poorly metabolized in patients with impaired liver function; discontinue the medication if jaundice develops
- Therapy may cause some degree of fluid retention; use cautiously with careful monitoring in patients with conditions which might be aggravated by fluid retention
- Closely monitor women with a history of depression; discontinue use if depression recurs to a serious degree
Use cautiously in
- Renal impairment
- Weight >90 kg
- History of depression
- Fluid retention
- Breastfeeding 6 wks-6 months postpartum
- Obesity
- Inflammatory bowel disease
- Hypercholesterolemia
- Vomiting or diarrhea
- Hereditary angioedema
Supplemental Patient Information
- Inform patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
- Instruct women to use an additional non-hormonal method of protection until after the first 7 days of administration, if the first patch is applied on the first Sunday after the onset of menses
- Instruct patients that the patch-free interval between dosing cycles should not exceed seven-day period
- Advise patients to apply the patch on clean, dry, and healthy intact skin on the buttock, abdomen, upper outer arm or upper torso where it won't be rubbed by tight clothing
- Advise patients to promptly report their physician on spotting or persisting breakthrough bleeding
- In case of a missed menstrual period, inform patients to consider the possibility of pregnancy, withholding hormonal contraceptives until pregnancy has been ruled out. Instruct patients to rule out pregnancy before continuing the contraceptive regimen even in patients who have adhered to the prescribed regimen but missed 2 consecutive periods
Pregnancy Category:X
Breastfeeding: Combination oral contraceptives probably do not affect the composition of milk substantially in healthy, well-nourished mothers and do not adversely affect long-term infant growth and development, but can transiently affect growth negatively during the first month after introduction. Rarely, reversible breast enlargement has been reported with higher doses of estrogen. Ethinyl estradiol in doses of 30 mcg daily or greater can suppress lactation leading to earlier discontinuation of breastfeeding than nonhormonal or progestin-only contraception. The magnitude of the effect on lactation likely depends on the dose and the time of introduction postpartum. As per US expert opinion, the risks of combination contraceptive products usually outweigh the benefits before 4 weeks postpartum. Between 4 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks. After 6 months postpartum, combination contraceptives, including oral tablets, the transdermal patch and vaginal ring, can be used, but progestin-only methods are preferred if breastfeeding will be continued. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 June 2011).Small amounts of combination hormonal contraceptive steroids are excreted in breastmilk of nursing mothers and a few adverse effects on the child have occurred, including jaundice and breast enlargement. Combination hormonal contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. Manufacturer advises the nursing mother to avoid using this product but to use other forms of contraception until she has completely weaned her child.
US Trade Name(s)
US Availability
Ortho Evra (ethinyl estradiol/norelgestromin)
- Extended Release TDP: [0.02 mg/0.15 mg]/24 hrs
Canadian Trade Name(s)
Canadian Availability
Evra (ethinyl estradiol/norelgestromin)
- Extended Release TDP: [35 mcg/200 mcg]/24 hrs
UK Trade Name(s)
UK Availability
Evra (ethinyl estradiol/norelgestromin)
- TDP: [33.9 mcg/203 mcg]/24 hrs
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Ortho Evra 150-20 MCG/24HR PTWK [Box] (JANSSEN)
1 24hr = $37.99
2 24hr = $65.97 - Ortho Evra 150-20 MCG/24HR PTWK [Box] (JANSSEN)
3 24hr = $90.99
9 24hr = $259.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
160 mm Hg or DBP