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VIRTUOSO™ is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following .
Molecular Formula : C 23 H 33 N 6 O 4 S +
Chemical Name : Vardenafil hydrochloride
CHEMBL1339 BDBM50111900
4-[4-Ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydro-imidazo[5,1-f][1,2,4]triazin-2-yl)-benzenesulfonyl]-1-ethyl-piperazin-1-ium; chloride
Molecular Weight :- 489.6 g/mol
| Name of the Product | GTIN - 14 |
|---|---|
| VIRTUOSO™ |
18906059770095 |
Mechanism of Action
Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus
cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from
nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme
guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the
smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation,
allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP
is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most
abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesterase type 5
(PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of
cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the
inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown
that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on
PDE5 than for other known phosphodiesterases (>15- fold relative to PDE6, >130-fold relative to
PDE1, >300-fold relative to PDE11, and >1,000- fold relative to PDE2, 3, 4, 7, 8, 9, and 10).
Uses
Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-
ED). In combination with sexual stimulation, vardenafil works by increasing blood flow to
the penis to help a man get and keep an erection.
This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis
B, gonorrhea , syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor
or pharmacist for more details.
How to use VIRTUOSO™
Read the Patient Information Leaflet provided by your pharmacist before you start taking
vardenafil and each time you get a refill. If you have any questions, ask your doctor or
pharmacist.
Take this medication by mouth as directed by your doctor, usually as needed. Take vardenafil,
with or without food, about 1 hour before sexual activity. Do not take more than once daily.
Doses should be taken at least 24 hours apart.
The dosage is based on your medical condition, response to treatment, and
other medications you may be taking. Be sure to tell your doctor and pharmacist about all the
products you use (including prescription drugs, nonprescription drugs, and herbal products).
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your
doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side
effects with this medicine. Ask your doctor or pharmacist for more details.
Side Effects
Headache, flushing, stuffy/runny nose, or dizziness may occur. Vision changes such as increased
sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If
any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness , get up slowly when rising from a sitting or
lying position.
Remember that your doctor has prescribed this medication because he or she has judged that
the benefit to you is greater than the risk of side effects. Many people using this medication do
not have serious side effects.
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 and
get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.
Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION)
may occur. If this serious problem occurs, stop taking vardenafil and get medical help right.
Precautions
Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any
other allergies. This product may contain inactive ingredients, which can cause allergic reactions
or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially
of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6
months, chest pain/angina, heart failure), stroke in the past 6 months, kidney
disease (dialysis), liver disease, high or low blood pressure, a severe loss of body water
(dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease ), history
of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such
as sickle cell anemia, leukemia , multiple myeloma), eye problems (such as retinitis pigmentosa,
sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.
Vardenafil may cause a condition that affects the heart rhythm (QT prolongation). QT
prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms
(such as severe dizziness, fainting) that need medical attention right away.
Interactions
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side
effects. This document does not contain all possible drug interactions. Keep a list of all the
products you use (including prescription/nonprescription drugs and herbal products) and share
it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines
without your doctor's approval.
A product that may interact with this drug is: riociguat.
Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can
lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of
the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin ,
isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.
If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin ) to treat
an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which
can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of vardenafil
to minimize your risk of low blood pressure.
Other medications can affect the removal of vardenafil from your body, which may affect how
vardenafil works. Examples include azole antifungals (such as itraconazole , ketoconazole),
macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such
as indinavir , ritonavir), hepatitis C virus protease inhibitors (such
as boceprevir , telaprevir ), rifampin , among others.
Many drugs besides vardenafil may affect the heart rhythm (QT prolongation),
including amiodarone, procainamide, quinidine, sotalol , among others.
Do not take this medication with any other product that contains vardenafil or other similar
medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil,
tadalafil).
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing.
Call your Doctor/ Healthcare professionals immediately when any adverse effects are reported.
Notes
Do not share this medication with others.
Missed Dose
Not applicable.
Storage
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep
all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
Properly discard this product when it is expired or no longer needed.