ORTHO EVRA DRUG INFO
IMPORTANT NOTE: The
following information is intended to supplement, not substitute
for, the expertise and judgment of your physician, pharmacist or
other healthcare professional. It should not be construed to indicate
that use of the drug is safe, appropriate, or effective for you.
Consult your healthcare professional before using this drug.
ETHINYL ESTRADIOL/NORELGESTROMIN PATCH
- TOPICAL (ETH-in-il ess-tra-DYE-ole/nor-el-JESS-troh-min)
COMMON BRAND NAME(S): Ortho Evra
WARNING: Smoking cigarettes while
using this medication increases your chance of having heart problems.
Do not smoke while using this medication. The risk of heart problems
increases with age (women greater than 35 years of age) and with
frequent smoking (15 cigarettes per day or greater).
USES: This combination hormone
patch is used to prevent pregnancy. It contains hormones similar
to those in birth control pills. The hormones release from the patch
slowly over time. Using this medication patch does not protect you
or your partner against HIV or other sexually transmitted diseases
(STDs).
HOW TO USE: Review the Patient
Information Leaflet. Follow all instructions on how to use this
medication patch and also the best time (during your menstrual cycle)
to start using the patch. If any of the information is unclear,
consult your doctor or pharmacist. Open the patch container and
apply one patch to an area of clean, dry skin on the buttock, abdomen,
upper outer arm, or upper body (torso) exactly as directed by your
doctor. The patch is worn for 7 days. Do not apply the patch to
the breast(s), the area around the breast(s); to red, cut, or irritated
skin; or over other topical products (e.g., make-up, creams, lotions,
powders). After 7 days, remove the old patch and apply a new patch.
Repeat this weekly cycle for 3 weeks (3 patches equal 1 cycle).
After your third patch is removed, you will have one week without
using the patch. Your menstrual cycle (period) usually should start
during the week when you do not use the patch. If your menstrual
cycle (period) does not begin during this week, consult your doctor.
After your 4th week, begin a new patch cycle, even if you still
are experiencing some bleeding (still having your period). Do not
go longer than 7 days without a patch. Doing so may make this medication
less effective. If the medication patch accidentally comes off,
is removed, or if it becomes detached, apply a new patch. If it
is detached or comes off for longer than 24 hours, or if you are
not sure how long the patch has been detached or removed, use additional
forms of birth control (e.g., condoms, spermicide) for at least
7 days and continue with the same cycle. After removing each patch,
fold the patch in half so it sticks to itself and discard it in
a trash container. Do not discard or flush the patches down a toilet.
If you weigh more than 198 pounds (90 kg), this patch may not work
as well for you. Make sure your doctor knows your current weight
and ask about which form of birth control is best for you. If any
of this information is unclear, consult the Patient Information
Leaflet or your doctor or pharmacist.
SIDE EFFECTS: Nausea, vomiting, headache, redness or itching
at the patch application site, dizziness, breast tenderness, vaginal
discomfort/irritation, or stomach cramping/bloating may occur. If
any of these effects persist or worsen, notify your doctor. Promptly
tell your doctor if any of these side effects occur: dark patches
on the skin (melasma), change in appetite, weight changes (gain
or loss), problem wearing contact lenses. Tell your doctor immediately
if any of these serious side effects occur: unusual vaginal discharge,
changes in vaginal bleeding (e.g., spotting, breakthrough bleeding,
prolonged or complete stoppage of bleeding), swelling, severe headache,
mental/mood changes. Tell your doctor immediately if any of these
unlikely but serious side effects occur: pain in the groin or lower
legs, trouble breathing, rash, chest pain, stomach pain, vision
or eye problems. Tell your doctor immediately if any of these highly
unlikely but very serious side effects occur: yellowing eyes or
skin, dark urine, one-sided weakness, numbness in the arms/legs,
lumps in the breast. If you notice other effects not listed above,
contact your doctor or pharmacist.
PRECAUTIONS: This medication is
not recommended for use if you have the following medical conditions:
blood circulation problems (e.g., history of blood clots in the
legs or groin), history of heart disease or stroke, severe high
blood pressure, diabetes (especially affecting the circulation),
severe headaches, recent major surgery, long periods of sitting
or lying down (e.g., immobility such as being bedridden), liver
problems, history of yellowing eyes and skin (jaundice) during pregnancy
or while using birth control pills, cancer (especially endometrial
or breast cancer), undiagnosed abnormal vaginal bleeding, currently
pregnant, heavy tobacco use (if 35 years old or greater). Tell your
doctor your medical history, especially of: high cholesterol or
triglyceride (fat) levels, depression, high blood pressure, gallbladder
problems, thyroid problems, any allergies. Do not smoke cigarettes.
Hormonal birth control (e.g., pills, injections, devices) products
combined with smoking cigarettes significantly increase your risk
for strokes, blood clots, high blood pressure, and heart attacks;
especially in women older than 35 years of age. Ask your doctor
or pharmacist or consult the patient information leaflet that comes
with this product for more details. Before having surgery, including
dental surgery, tell the doctor(s) that you are using this product.
The drugs in this patch may cause blotchy, dark areas on your skin
(melasma) and sunlight may intensify this effect. If this occurs,
avoid prolonged sun exposure, use a sunscreen, and wear protective
clothing when outdoors. If you are near-sighted or wear contact
lenses, you may develop vision problems or may have problems wearing
your contact lenses. Contact your eye doctor if these problems occur.
This medication device must not be used in pregnancy. If you become
pregnant or think you may be pregnant, inform your doctor immediately.
The medication from this patch passes into breast milk and may have
undesirable effects on the nursing infant. Consult your doctor before
breast-feeding.
DRUG INTERACTIONS: Tell your doctor
of all prescription and nonprescription medication you may use,
especially: anti-seizure medicine (e.g., carbamazepine, felbamate,
phenobarbital, phenytoin, topiramate), certain antibiotics (e.g.,
ampicillin, erythromycin), HIV protease inhibitors (e.g., indinavir,
ritonavir), phenylbutazone, griseofulvin, atorvastatin, azole antifungals
(e.g., itraconazole, ketoconazole), rifampin, St John's wort, cyclosporine,
temazepam, prednisolone, morphine, theophylline, ascorbic acid (vitamin
C), acetaminophen, aspirin, clofibric acid, modafinil, troglitazone.
This product can affect the results of certain lab tests (e.g.,
blood tests such as glucose, clotting factors, or thyroid). Make
sure laboratory personnel and your doctors know you use this product.
Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: Overdose with this product
is highly unlikely. If overdose is suspected, remove the patch (or
patches) and contact your local poison control center or emergency
room immediately. This medicine device may be harmful if swallowed.
Symptoms of overdose may include: severe nausea, vomiting, unusual
vaginal bleeding or irregular menstrual periods.
NOTES: Do not share this medication
patch with others. Keep all appointments with your doctor and when
having laboratory tests performed. You should have a complete physical
exam including blood pressure, breast exams, pelvic exams, and PAP
smears at least once a year.
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