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 | ORTHO EVRA, the first birth control patch, has been approved by the U.S. Food and Drug Administration (FDA). It is now available for prescription from your doctor or healthcare professional.
ORTHO EVRA is a once-a-week birth control option that'
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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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