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What is the most important information I should know about
vardenafil?
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A small number of patients have lost eyesight in one eye after
taking vardenafil. This type of vision loss is called non-arteritic
anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss
of eyesight because
blood flow is blocked to the optic nerve. It is not clear at this
time if vardenafil causes NAION. NAION also happens in patients who do
not take this medicine. People who have a higher chance for NAION
include those who: |
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have high blood pressure; |
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have certain eye problems. |
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Stop using vardenafil if you have any loss in your eyesight and seek
medical help right away. |
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Do not take vardenafil if you are taking any of the following
medicines: |
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a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
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a recreational drug such as amyl nitrate or nitrite ("poppers"); or |
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an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel),
prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral),
tamsulosin (Flomax), and others. |
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Taking vardenafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack |
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Contact your doctor or seek emergency medical attention for any
erection that lasts longer than 4 hours. A sustained erection can damage
the penis. |
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• |
Refrain from further sexual activity and notify your doctor it you
develop dizziness, nausea, or angina (pain, tightness, discomfort,
numbness, or tingling in the chest, arms, neck, or jaw) during sexual
activity. |
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Do not take vardenafil more than once a day. In some cases, use of
vardenafil may be restricted to once every 72 hours (3 days). Follow
your doctor's instructions. |
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Vardenafil relaxes muscles within the penis. This allows increased
blood flow into the penis which is necessary to achieve and maintain an
erection. |
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Vardenafil is used to treat erectile dysfunction (impotence). |
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Vardenafil may also be used for purposes other than those listed in
this medication guide. |
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What should I discuss with my healthcare provider before taking
vardenafil?
|
|
• |
A small number of patients have lost eyesight in one eye after
taking vardenafil. This type of vision loss is called non-arteritic
anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss
of eyesight because blood flow is blocked to the optic nerve. It is not
clear at this time if vardenafil causes NAION. NAION also happens in
patients who do not take this medicine. People who have a higher chance
for NAION include those who: |
| |
· |
have high blood pressure; |
| |
· |
have certain eye problems. |
|
• |
Stop using vardenafil if you have any loss in your eyesight and seek
medical help right away. |
|
• |
Do not take vardenafil if you are taking any of the following
medicines: |
| |
· |
a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
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· |
a recreational drug such as amyl nitrate or nitrite ("poppers"); or |
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· |
an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel),
prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral),
tamsulosin (Flomax), and others. |
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Taking vardenafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack |
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Before taking vardenafil, tell your doctor if you |
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currently have or have ever had a heart attack, stroke, irregular
heartbeats, angina (chest pain), or congestive heart failure; |
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have high or low blood pressure; |
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have a personal or family history of a rare heart condition known as
prolongation of the QT interval (long QT syndrome); |
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have ever had blood problems, including sickle cell anemia, multiple
myeloma, or leukemia; |
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have a bleeding or blood clotting disorder; |
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a family history of degenerative eye disease (e.g., retinitis
pigmentosa); or |
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have a physical deformity of the penis such as Peyronie's disease. |
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You may not be able to take vardenafil, or you may require a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. |
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Although vardenafil is not indicated for use by women, it is in the
FDA pregnancy category B. This means that vardenafil is not expected to
be harmful to an unborn baby. Vardenafil should not be taken by women. |
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It is not known whether vardenafil passes into breast milk.
Vardenafil should not be taken by women. |
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If you are over 65 years of age, you may be more likely to
experience side effects from vardenafil. Your doctor may prescribe a
lower dose of the medication. |
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How should I take vardenafil?
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Take vardenafil exactly as directed by your doctor. If you do not
understand these directions, ask your pharmacist, nurse, or doctor to
explain them to you. |
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Take each dose with a full glass of water. |
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Vardenafil can be taken with or without food. |
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Vardenafil is usually taken when needed. Generally, it is taken
about 1 hour before sexual activity. The medication can help achieve an
erection when sexual stimulation occurs. An erection will not occur just
by taking a pill. Follow your doctor's instructions. |
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Vardenafil should not be taken with grapefruit or grapefruit juice.
Vardenafil can interact with grapefruit and grapefruit juice, and the
interaction may have dangerous effects. You should discuss the use of
grapefruit and grapefruit juice with your doctor. |
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Do not take vardenafil more than once a day. In some cases, use of
vardenafil may be restricted to once every 72 hours (3 days). Follow
your doctor's instructions. |
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If you develop dizziness, nausea, or angina (pain, tightness,
discomfort, numbness, or tingling in the chest, arms, neck, or jaw)
during sexual activity, refrain from further sexual activity and notify
your doctor. |
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• |
Contact your doctor or seek emergency medical attention for any
erection that lasts longer than 4 hours. A sustained erection can damage
the penis. |
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Store this medication at room temperature away from moisture and
heat. |
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What happens if I miss a dose?
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Vardenafil is used as needed, so you are not likely to miss a dose. |
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What happens if I overdose?
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Seek emergency medical attention if an overdose is suspected. |
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Symptoms of a vardenafil overdose are not known, but are likely to
include chest pain, back pain, dizziness, an irregular heartbeat,
abnormal vision, and swelling of the ankles or legs. |
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What should I avoid while taking vardenafil?
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Do not take any other drug used to treat impotence, such as
alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others),
without first talking to your doctor. |
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Vardenafil should not be taken with grapefruit or grapefruit juice.
Vardenafil can interact with grapefruit and grapefruit juice, and the
interaction may have dangerous effects. You should discuss the use of
grapefruit and grapefruit juice with your doctor. |
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What are the possible side effects of vardenafil?
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If you experience any of the following serious side effects, stop
taking vardenafil and seek emergency medical attention or contact your
doctor immediately: |
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an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives); |
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chest pain or an irregular heartbeats; |
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swelling of the ankles or legs; |
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prolonged or severe dizziness; |
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a prolonged (lasting longer than 4 hours) or painful erection; |
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dizziness, nausea, or angina (pain, tightness, discomfort, numbness,
or tingling in the chest, arms, neck, or jaw); or |
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Other, less serious side effects may be more likely to occur.
Continue to take vardenafil and talk to your doctor if you experience |
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sensitivity of the eyes to light; or |
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temporary blue tint in vision or other vision abnormalities. |
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Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
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What other drugs will affect vardenafil?
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• |
Do not take vardenafil if you are taking any of the following
medicines: |
| |
· |
a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur,
Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide
dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur,
ISMO, Monoket), and others; |
| |
· |
a recreational drug such as amyl nitrate or nitrite ("poppers"); or |
| |
· |
an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel),
prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral),
tamsulosin (Flomax), and others. |
|
• |
Taking vardenafil with any of these medications may cause very low
blood pressure, possibly resulting in dizziness, fainting, stroke, or
heart attack |
|
• |
Before taking vardenafil, tell your doctor if you are taking any of
the following medications: |
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any other drug used to treat impotence, such as alprostadil (Caverject,
Muse, Edex) or yohimbine (Yocon, Yodoxin, others); |
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the antibiotic drug erythromycin (E-Mycin, Eryc, Ery-Tab, others); |
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an antifungal medication such as itraconazole (Sporanox) or
ketoconazole (Nizoral); |
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a medication used to treat irregular heartbeats such as quinidine (Quinaglute,
Quinidex, Quin-Release), procainamide (Procan SR, Procanbid, Pronestyl),
amiodarone (Cordarone, Pacerone), or sotalol (Betapace, Sorine); or |
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the HIV medications indinavir (Crixivan) or ritonavir (Norvir). |
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You may not be able to take vardenafil, or you may require a dosage
adjustment or special monitoring during treatment if you are taking any
of the medicines listed above. |
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Drugs other than those listed here may also interact with vardenafil
or affect your condition. Talk to your doctor or pharmacist before
taking any prescription or over-the-counter medicines, including
vitamins, minerals, and herbal products. |
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Where can I get more information?
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Your pharmacist has additional information about vardenafil written
for health professionals that you may read. |
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Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
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Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2005 Cerner Multum, Inc. Version: 3.01. Revision date: 7/
11/ 05. |