Label: VARDENAFIL tablet, orally disintegrating

12.2 Pharmacodynamics
8.4 Pediatric Use
What It Contains
2.2 Use with Food
What are the future revenue projections and growth drivers?

Reduce vardenafil dose if coadministered with moderate CYP3A inhibitors. rilzabrutinib increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ritonavirritonavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Adjust dosage of CYP3A4 substrates, if clinically indicated. rucaparib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. rufinamiderufinamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Ingredient	Amount per Tablet	Purity	Source
Vardenafil Hydrochloride	10 mg	99.9%	Pharmacological grade
Lactose Monohydrate	50 mg	–	Dairy-derived
Microcrystalline Cellulose	20 mg	–	Plant fiber
Magnesium Stearate	2 mg	–	Mineral source
Colloidal Silicon Dioxide	1 mg	–	Silicon dioxide

rufinamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. selpercatinibselpercatinib increases toxicity of vardenafil by QTc interval. selpercatinib increases toxicity of vardenafil by QTc interval.

12.2 Pharmacodynamics

drospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. labetalolvardenafil increases effects of labetalol by pharmacodynamic synergism. vardenafil increases effects of labetalol by pharmacodynamic synergism. Possible additive vasorelaxation, leading to low blood pressure. Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) There have been rare reports of prolonged erections >4 hr and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure Consider counseling patients about protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV); drug offers no protection against sexually transmitted diseases Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Safety and efficacy of drug used in combination with other treatments for erectile dysfunction not studied; use of such combinations not recommended Vision loss may occur rarely and may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); patient should seek medical assistance for sudden loss in one or both eyes; patients who have already experienced NAION are at increased risk of recurrence; use is not recommended in patients with known degenerative retinal disorders May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician The drug has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic); while this normally would be expected to be of little consequence in most patients, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects Physicians should advise patients to stop taking all PDE5 inhibitors, and seek prompt medical attention in event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to intake of PDE5 inhibitors, including vardenafil; it is not possible to determine whether these events are related directly to use of PDE5 inhibitors or to other factors CYP3A4 inhibitorsConcomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitorsLong-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Concomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitors Long-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Alpha blockersCaution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting)Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitorsIn patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting doseIn patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitorSafety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and o Coadministration of sepiapterin with drugs affecting nitric oxide-mediated relaxation may cause additive vasodilation and further reduce blood pressure. sertralinesertraline cenforce 200 tablets and vardenafil both increase QTc interval.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	20mg	30 + 4 Pills	68.05€ 64.81€
Cialis Original	20mg	48 + 4 Pills	224.69€ 213.99€
Levitra Professional	20mg	120 + 4 Pills	348.44€ 331.85€
Viagra Generic	100mg	10 Pills	28.91€ 27.53€
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Viagra Super Active	100mg	60 + 8 Pills	116.84€ 111.28€
Levitra Generic	40mg	360 + 10 Pills	704.99€ 671.42€
Cialis Generic	5mg	90 + 6 Pills	115.91€ 110.39€
Viagra Generic	100mg	20 Pills	45.58€ 43.41€
Cialis Original	20mg	8 Pills	61.70€ 58.76€
Levitra Generic	20mg	60 + 6 Pills	131.11€ 124.87€
Levitra Soft Tabs	20mg	120 + 8 Pills	288.52€ 274.78€
Kamagra Soft Tabs	100mg	32 Pills	120.11€ 114.39€
Kamagra 100 mg	100 mg	32 Pills	121.24€ 115.47€
Kamagra Gold	100 mg	32 Pills	121.24€ 115.47€
Cialis Generic	20mg	10 Pills	31.49€ 29.99€
Cialis Generic	60mg	120 + 8 Pills	240.18€ 228.74€

sertraline and vardenafil both increase QTc interval. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of vardenafil by QTc interval. sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of vardenafil by QTc interval.

8.4 Pediatric Use

Patient resources

rufinamiderufinamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. rufinamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. selpercatinibselpercatinib increases toxicity of vardenafil by QTc interval. selpercatinib increases toxicity of vardenafil by QTc interval. Coadministration of sepiapterin with drugs affecting nitric oxide-mediated relaxation may cause additive vasodilation and further reduce blood pressure.

What should I tell my healthcare provider before taking vardenafil?

sertralinesertraline cenforce 200 tablets and vardenafil both increase QTc interval. sertraline and vardenafil both increase QTc interval. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of vardenafil by QTc interval. sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of vardenafil by QTc interval. solifenacinsolifenacin and vardenafil both increase QTc interval.

Side effects can include headache, flushing, or stomach upset.
Serious side effects are rare but require immediate medical attention.
Vardenafil may cause changes in color vision.
Use caution if using other medication for blood pressure.
The medication helps improve erectile function temporarily.
Do not share tablets with others.
Follow storage instructions to maintain efficacy.
Report any allergic reactions promptly.
The drug should be used only under medical supervision.
Used responsibly, vardenafil can improve quality of life.

solifenacin and vardenafil both increase QTc interval. sorafenibsorafenib and vardenafil both increase QTc interval. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. sunitinibsunitinib and vardenafil both increase QTc interval.

Patient Type	Recommended Dose	Notes
Adult Men with ED	10 mg	1 hour before activity
Elderly Patients	5-10 mg	Adjust based on tolerability
Patients with Liver Impairment	5 mg	Lower dose recommended
Use with CYP3A4 inhibitors	5 mg	To reduce adverse risk

sunitinib and vardenafil both increase QTc interval. suzetriginesuzetrigine decreases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor patients for loss of therapeutic effect of sensitive CYP3A substrates with narrow therapeutic indexes when coadministered with suzetrigine. Consider modifying dose of sensitive substrate according to prescribing recommendations. suzetrigine decreases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

What It Contains

solifenacinsolifenacin and vardenafil both increase QTc interval. solifenacin and vardenafil both increase QTc interval. sorafenibsorafenib and vardenafil both increase QTc interval. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. sunitinibsunitinib and vardenafil both increase QTc interval.

Drug Interactions

2.2 Use with Food

tetracyclinetetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors tobramycin inhaledtobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity tobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Avoid concurrent or sequential use to decrease risk for ototoxicity topiramatetopiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Does vardenafil interact with foods or drinks?

topiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. valbenazinevalbenazine and vardenafil both fildena tablet increase QTc interval. valbenazine and vardenafil both increase QTc interval. verapamilverapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors verapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Related Disease Conditions

Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors Either increases effects of the other by QTc interval. voriconazolevoriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors voriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors vorinostatvorinostat and vardenafil both increase QTc interval. vorinostat and vardenafil both increase QTc interval. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors Either increases effects of the other by QTc interval. voriconazolevoriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Vardenafil 10 mg tablets treat erectile dysfunction in men.
The medication works by increasing blood flow to the penis.
Take vardenafil 10 mg about 30 minutes before activity.
It can be taken with or without food, but high-fat meals may delay effects.
Maximum recommended dose is one tablet per 24 hours.
Vardenafil may cause side effects like headache or flushing.
Do not use vardenafil if you take nitrates for chest pain.
Consult a doctor before using vardenafil if you have heart problems.
Store vardenafil tablets at room temperature, away from moisture.
Alcohol can increase side effects of vardenafil.

Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors voriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors vorinostatvorinostat and vardenafil both increase QTc interval.

What are the future revenue projections and growth drivers?

zafirlukastzafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozoleanastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Dosage Forms & Strengths

anastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. azithromycinazithromycin increases toxicity of vardenafil by QTc interval. azithromycin increases toxicity of vardenafil by QTc interval. carvedilolvardenafil increases effects of carvedilol by pharmacodynamic synergism. vardenafil increases effects of carvedilol by pharmacodynamic synergism.

What should I do if I miss a dose of vardenafil?

chloroquinechloroquine increases fildena 100mg toxicity of vardenafil by QTc interval. chloroquine increases toxicity of vardenafil by QTc interval. cyclophosphamidecyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. cyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenonedrospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. vorinostat and vardenafil both increase QTc interval. zafirlukastzafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamideacetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozoleanastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Drug Name	Dose Range	Duration of Action	Onset Time	Special Features
Vardenafil	5-20 mg	4-5 hours	30-60 min	Fast onset, good for food timing
Sildenafil	25-100 mg	4-6 hours	30-60 min	Well-studied, widespread use
Tadalafil	2.5-20 mg	Up to 36 hours	30-120 min	Long duration, daily options
Avanafil	50-200 mg	4-6 hours	15-30 min	Fastest onset, fewer side effects

Vardenafil 10 mg may be used by men over 18 years.
The medication is not approved for use in women or children.
May be contraindicated in patients with certain eye conditions.
Use caution if you have a history of stroke.
The drug’s chemical action involves improving blood flow.
It is important to distinguish ED causes before treatment.
Use only medications prescribed by a healthcare professional.
Avoid combining with other erectile dysfunction medications.
Keep medication out of sunlight and moisture.
Seek emergency medical help for severe side effects.

Some users may experience mild flickering vision episodes.
The efficacy of vardenafil varies between individuals.
The medication is available in various dosage forms.
Always follow the specific instructions provided.
Avoid taking vardenafil with high-fat meals to speed absorption.
Do not take vardenafil if allergic to its ingredients.
The drug may cause a temporary burning sensation.
Use caution in patients with a history of priapism.
Avoid combining vardenafil with certain herbal supplements.
Consult your doctor about any ongoing health treatments.

drospirenonedrospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. drospirenone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. labetalolvardenafil increases effects of labetalol by pharmacodynamic synergism. vardenafil increases effects of labetalol by pharmacodynamic synergism. Possible additive vasorelaxation, leading to low blood pressure. Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) There have been rare reports of prolonged erections >4 hr and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure Consider counseling patients about protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV); drug offers no protection against sexually transmitted diseases Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug Safety and efficacy of drug used in combination with other treatments for erectile dysfunction not studied; use of such combinations not recommended Vision loss may occur rarely and may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); patient should seek medical assistance for sudden loss in one or both eyes; patients who have already experienced NAION are at increased risk of recurrence; use is not recommended in patients with known degenerative retinal disorders May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician The drug has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic); while this normally would be expected to be of little consequence in most patients, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects Physicians should advise patients to stop taking all PDE5 inhibitors, and seek prompt medical attention in event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to intake of PDE5 inhibitors, including vardenafil; it is not possible to determine whether these events are related directly to use of PDE5 inhibitors or to other factors CYP3A4 inhibitorsConcomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitorsLong-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Concomitant administration with potent CYP3A4 inhibitors (eg, ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (eg, erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitors Long-term safety information is not available on concomitant administration of drug with HIV protease inhibitors Alpha blockersCaution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting)Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitorsIn patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting doseIn patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitorSafety of combined use of other PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and o