Ortho Evra Patch Information:
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 the Ortho Evra 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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