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.
VARDENAFIL - ORAL
(var-DEN-ah-fil)
COMMON BRAND NAME(S): Levitra
USES: This medication is a phosphodiesterase inhibitor used to
treat male sexual function problems (impotence or erectile dysfunction).
In combination with sexual stimulation, vardenafil works by helping
the blood flow into the penis to achieve and maintain an erection.
This drug is not indicated for use in women. Use of this drug
does not protect against sexually transmitted diseases (e.g.,
HIV, hepatitis B, gonorrhea, syphilis). Use "safe sex"
practices (e.g., latex condoms). Consult your doctor or pharmacist
for more details.
HOW TO USE: This drug is taken by mouth as needed, one hour before
sexual activity with or without food; or use as directed by your
doctor. Do not take more often than once daily as needed. A high
fat meal may decrease the amount of drug that is absorbed. Avoid
eating grapefruit or drinking grapefruit juice while you are being
treated with this medication unless your doctor instructs you
otherwise. The dosage is based on your medical condition, response
to therapy, and other medications you may be taking (see also
Drug Interactions section). Consult your doctor or pharmacist
for more
details. Read the patient information leaflet provided by your
pharmacist.
SIDE EFFECTS: Headache, flushing, nasal stuffiness,
stomach upset, heartburn, runny nose, dizziness, or nausea may
occur. Vision changes such as increased sensitivity to light,
blurred vision, or impaired blue/green color discrimination may
also occur. If any of these effects persist or worsen, notify
your doctor or pharmacist promptly. Tell your doctor immediately
if any of these highly unlikely but very serious side effects
occur: fast/slow/irregular heartbeat. Sexual activity may put
extra strain on your heart, especially if you have heart problems.
If you have heart problems and experience any of these serious
side effects while having sex, stop having sex and tell your doctor
immediately of: severe dizziness, fainting, chest pain. In the
unlikely event you have a painful or prolonged erection (lasting
more than 4 hours), stop using this drug and seek immediate medical
attention or permanent problems could occur. An allergic reaction
to this drug is unlikely, but seek immediate medical attention
if it occurs. Symptoms of an allergic reaction include: rash,
itching, unusual swelling, severe dizziness, trouble breathing.
If you notice other effects not listed above, contact your doctor
or pharmacist.
PRECAUTIONS: Before using this medication, tell
your doctor or pharmacist your medical history, especially of:
penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's
disease), history of painful/prolonged erection (priapism), sickle
cell anemia, blood system cancers (e.g., leukemia or myeloma),
eye problems (e.g., retina diseases like retinitis pigmentosa),
kidney disease, liver disease, bleeding disorders, active stomach
ulcers, heart problems (e.g., recent heart attack or serious arrhythmia
within past 6 months, heart failure, coronary artery disease with
unstable angina, aortic stenosis, idiopathic hypertrophic subaortic
stenosis, congenital QT prolongation), recent stroke within past
6 months, very high or low blood pressure, any allergies. This
drug may make you dizzy or cause vision changes; use caution engaging
in activities requiring alertness such as driving or using machinery.
Limit alcoholic beverages. To minimize dizziness and lightheadedness,
get up slowly when rising from a seated or lying position. Caution
is advised when using this drug in the elderly because they may
be more sensitive to the side effects of the drug. This drug is
not indicated for use in women or children.
DRUG INTERACTIONS: See also How To Use section
for drug-food interactions. This drug should not be used with
the following medications because very serious interactions may
occur: nitrates (e.g.,
nitroglycerin, isosorbide), nitroprusside (or any "nitric
oxide donor" drugs), recreational drugs called "poppers"
containing amyl or butyl nitrite, alpha-blocker medication (e.g.,
doxazosin, prazosin, terazosin). If you are currently using any
of these medications, tell your doctor or pharmacist before starting
vardenafil. Before using this medication, tell your doctor or
pharmacist of all prescription and nonprescription products you
may use, especially of: other medications for impotence, drugs
that affect certain liver enzymes (CYP 3A4 substrates, inhibitors
and inducers, e.g., cimetidine, rifamycins, St. John's wort, certain
anti-seizure meds), high blood pressure medicines. If you are
taking ritonavir, do not take more than a 2.5mg dose of vardenafil
in a 72 hour period. If you are taking indinavir or high doses
(400mg daily) of either ketoconazole or itraconazole, do not take
more than a 2.5mg dose of vardenafil per day. If you are taking
erythromycin or low doses (200mg daily) of either ketoconazole
or itraconazole, do not take more than 5mg dose of vardenafil
per day. For more details contact your doctor or pharmacist. Other
drugs besides vardenafil which may affect the heart rhythm (QTc
prolongation in the EKG) include dofetilide, pimozide, amiodarone,
quinidine, sotalol, procainamide, and sparfloxacin among others.
QTc prolongation can infrequently result in serious, rarely fatal,
irregular heartbeats. Consult your doctor or pharmacist for details
before taking vardenafil. Ask for instructions about whether you
need to stop any other QTc-prolonging drugs you may be using in
order to minimize the risk of this effect. Do not start or stop
any medicine without doctor or pharmacist
approval.
OVERDOSE: If overdose is suspected, contact your local poison
control center or emergency room immediately. Symptoms of overdose
may include back pain, muscle pain, abnormal vision.
NOTES: Do not share this medication with others,
since they may have a problem that is not effectively treated
by this drug, or they may have a condition that is complicated
by this drug.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature at
77 degrees F (25 degrees C) away from light and moisture. Brief
storage between 59 and 86 degrees F (15-30 degrees C) is permitted.
Do not store in the bathroom. Keep all medicines away from children
and pets.