Ortho Evra Indications and Dosage
- acne vulgaris †
- amenorrhea †
- contraception
- dysfunctional uterine bleeding †
- endometriosis †
- hirsutism †
- polycystic ovary syndrome †
† non-FDA-approved indication
Ortho Evra Indications and Dosage
For routine contraception:
- no preceding hormonal contraceptive use in the past month (basic dosage instructions):
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: Apply 1 transdermal system (delivering 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol per 24 hours) topically to the skin (
see Administration). The patch is removed and reapplied once weekly (every 7 days) for 3 weeks, followed by a patch-free period of 1 week before resuming the dosage cycle.
- to change the ‘patch change day’:
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: The female should complete her current cycle, removing the third patch on the correct day. During the patch-free week, she may select an earlier patch change day by applying a new patch on the desired day. In no case should there be more than 7 consecutive patch-free days.
- if a woman forgets to change her patch:
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: If the patch cycle (Week 1/Day 1) is not started on time; protection from pregnancy may not occur. Apply the first-week patch of a new cycle as soon as it is remembered. Assign this as the new ‘patch change day’. Use back-up non-hormonal contraception for the first week of new cycle. If a patch is forgotten in the middle of the cycle (Week 2 or Week 3) for 1 - 2 days (< 48 hours), apply a new patch immediately. Apply the next weekly patch on the usual ‘patch change day.’ No back-up contraception is needed. If a patch is forgotten mid-cycle (Week 2 or Week 3) for > 2 days (>= 48 hours), protection from pregnancy may not occur. Stop the current contraceptive cycle. Start a new 4-week cycle immediately by applying a new patch. Assign this as the new ‘patch change day’. Use back-up non-hormonal contraception for the first week of new cycle. If the woman forgets to remove her patch at the end of the patch cycle (Week 4/Day 22), she should take it off as soon as she remembers. Start the next cycle on the usual day, which is the day after Day 28. No back-up contraception is needed. There should not be more than a 7-day patch-free interval between cycles. If there are > 7 patch-free days, protection from pregnancy may not occur; use back-up non-hormonal contraception for 7 days. The risk of ovulation increases with each day beyond the recommended drug-free period.
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: A patch should not be re-applied if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has become loose or fallen off before. If a patch cannot be re-applied, a new patch should be applied immediately. Supplemental adhesives or wraps should not be used to hold an old patch in place. If a patch is partially or completely detached for >= 24 hours OR if the patient is unsure how long the patch has been detached, she may not be protected from pregnancy. She should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. Back-up non-hormonal contraception must be used for the first week of the new cycle.
- to switch from an oral contraceptive (OC) to this patch contraceptive:
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: Apply 1 transdermal system (delivering 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol per 24 hours) topically to the skin on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active OC tablet, rule out pregnancy before beginning the patch. If therapy starts later than the first day of withdrawal bleeding, use a non-hormonal contraceptive concurrently for 7 days. The patch is removed and reapplied once weekly (every 7 days) for 3 weeks, followed by a patch-free period of 1 week before resuming the dosage cycle.
- for contraception after childbirth:
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: Females who elect not to breast-feed should start contraceptive therapy with this patch no sooner than 4 weeks after childbirth. If a woman begins using this drug postpartum, and has not yet had a period, the possibility of conception occurring prior to use of the patch should be considered; instruct patient to use an additional non-hormonal method of contraception for the first 7 days. When
Ortho Evra™ is used postpartum, the increased risk of thromboembolic disease must be considered.
- for contraception after abortion or miscarriage:
Transdermal dosage (
Ortho Evra™):
Adult and adolescent females: After an abortion or miscarriage that occurs in the first trimester, the patch may be started immediately; an additional method of contraception is not needed if started immediately. If patch is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting the drug for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage. Do not start this patch earlier than 4 weeks after a second trimester abortion or miscarriage. When
Ortho Evra™ is used postabortion, the increased risk of thromboembolic disease must be considered.
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:
Transdermal dosage (Ortho Evra™):
Adult and adolescent females: Follow dosage as for routine contraception. Improvement may not be noticeable for 2 - 4 months. Prolonged treatment may be needed to control condition.
For the treatment or adjuvant treatment of amenorrhea † , 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:
Transdermal dosage (Ortho Evra™):
Adult and adolescent females: Follow dosage as for routine contraception. Treatment for 6 - 12 months may be required; hormonal contraceptives have limited utility when the underlying cause is not related to a hypoestrogenic or hyperandrogenic state.
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:
Transdermal dosage (Ortho Evra™):
Adult and adolescent females: Follow dosage as for routine contraception. Treatment for 6 - 9 months may be needed to induce endometrial atrophy and reduce symptoms.
Maximum Dosage Limits:
- Adults: 1 patch/week transdermally.
- Elderly: Not indicated.
- Adolescents: 1 patch/week transdermally.
- Children: Not indicated in prepubescent females.
Patients with hepatic impairment:
Hormonal contraceptives are contraindicated for use in the presence of active liver disease or markedly impaired liver function.
Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; Ortho Evra™ has not been studied in these patients.
† non-FDA-approved indication
[ Last revised: 1/23/2003 12:47:00 PM ]
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