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Drug name:
Ortho-Evra
Ortho Evra - Overview
Ortho Evra® is
a safe, effective and easy-to-use birth control
patch for women. Ortho Evra is the first birth control
patch approved by the U.S. FDA, and the first
weekly form of birth control that is as effective
as the Pill. Ortho Evra® is a small, thin patch,
designed to be worn under your clothes; it's easy
to wear, and is more than 99% effective when used
correctly.
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Warning
Smoking
cigarettes while using Ortho Evra increases your
chance of having heart problems. Do not smoke while
using Ortho Evra. 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).
Ortho Evra 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
Ortho Evra patch does not protect you or your
partner against HIV or other sexually transmitted
diseases (STDs).
How to use Ortho Evra
Review the
Patient Information Leaflet. Follow all instructions on
how to use Ortho Evra 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. Ortho Evra 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 Ortho Evra 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 Ortho Evra patch. Doing so may make Ortho Evra 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 Ortho Evra 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.
Ortho Evra 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.
Ortho Evra Precautions
Ortho Evra 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 Ortho Evra 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. Ortho Evra 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.
Ortho Evra Overdose
Overdose with
Ortho Evra is highly unlikely. If overdose is
suspected, remove the patch (or patches) and contact
your local poison control center or emergency room
immediately. Ortho Evra 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 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.