Label: VARDENAFIL HYDROCHLORIDE tablet

The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day.

• Vardenafil 10mg can help improve sexual confidence and satisfaction.
• Use it responsibly to maintain health and efficacy.
• Check for any medication allergies before use.
• Inform your doctor about all health conditions prior to starting.
• Do not take vardenafil if you have recent cardiovascular events.
• Avoid excessive alcohol, which can worsen side effects.
• Report any unexpected symptoms to your healthcare provider.
• Follow your doctor’s instructions for dosage and timing.
• Be aware of the medication’s interaction with other drugs.
• Proper storage ensures the medication’s effectiveness and safety.

Sexual stimulation is required for a response to treatment.2.3 Use in Specific PopulationsGeriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)].Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended.

• Vardenafil HCl 10mg is available in tablet form, usually taken orally.
• It’s important to follow your doctor’s instructions precisely for effectiveness.
• Do not use vardenafil if you have a known allergy to similar drugs.
• Alcohol can increase side effects, such as dizziness and low blood pressure.
• Men with pre-existing eye conditions should proceed with caution.
• Keep a record of any side effects experienced to inform your doctor.
• Use of vardenafil should be part of a broader approach to managing ED.
• Check for drug interactions with your pharmacist before starting therapy.
• Certain health conditions may require dose adjustments or caution.
• The medication is not intended for use as a performance enhancer.

The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .Renal Impairment: Do not use vardenafil hydrochloride tablets in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].2.4 Concomitant MedicationsNitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)]Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)].CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2 )].If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows:Ritonavir: No more than 2.5 mg in a 72-hour period.Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period.Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.Cobicistat: No more than 2.5 mg in a 72 hour period.Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.

Side Effect	Incidence Rate	Severity	Notes
Headache	Common	Mild to moderate	Usually temporary
Flushing	Common	Mild	Warm sensation
Nasal Congestion	Common	Mild	Sneezing, stuffy nose
Dizziness	Less frequent	Mild	When standing up quickly

In those patients who are stable on alpha-blocker therapy, vardenafil hydrochloride tablets should be initiated at a dose sex for man tablet of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors).

Related/similar drugs

Renal Impairment: Do not ed treatment drugs use vardenafil hydrochloride tablets in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Nitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)] Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)]. CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2 )]. Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. [See Warnings and Precautions (5.6) and Drug Interactions (7.1).] A time interval between dosing should be considered when vardenafil hydrochloride tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)] .

Storage Class

4 CONTRAINDICATIONS 4.1 NitratesAdministration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. Administration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] . 5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.Before prescribing vardenafil hydrochloride tablets, it is important to note the following:5.1 Cardiovascular EffectsGeneralPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

InChI key

Therefore, treatment for erectile dysfunction, including vardenafil hydrochloride tablets, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: 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 the last 6 months); severe cardiac failure.Left Ventricular Outflow ObstructionPatients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic super p force online hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.Blood Pressure EffectsVardenafil hydrochloride tablets have 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) [see Clinical Pharmacology (12.2)] . While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 InhibitorsConcomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Dosage adjustment is necessary when vardenafil hydrochloride tablets are administered with certain CYP3A4 inhibitors [see Dosage and Administration (2.4), and Drug Interactions (7.2)].Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors.5.3 Risk of PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. In the event that an erection persists longer than 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.Vardenafil hydrochloride tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).5.4 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes. [See Warnings and Precautions (5.6) and Drug Interactions (7.1).

• Vardenafil HCl 10mg can be an effective treatment when used responsibly.
• Always follow the prescribed dosing schedule for safety and efficacy.
• The medication may need to be adjusted based on individual response.
• Use with caution if you have a history of cardiovascular disease.
• Discuss all current medications with your doctor to avoid interactions.
• Vardenafil is not recommended for use by women or children.
• Be aware of possible side effects and seek medical help when needed.
• Alcohol and fatty foods can interfere with the drug’s performance.
• Proper sexual stimulation is required for the drug to work effectively.
• Regular follow-up with your healthcare provider is encouraged.

]A time interval between dosing should be considered when vardenafil hydrochloride tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)] .

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For most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. Sexual stimulation is required for a response to treatment.

What should I know about storage and disposal of this medication?

Some side effects can be serious. If you experience any of the following symptoms , call your doctor immediately:

Best Wholesale Price for VARDENAFIL HCL

Geriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)]. Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] . Renal Impairment: Do not ed treatment drugs use vardenafil hydrochloride tablets in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Nitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)] Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)]. CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2 )].

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. [See Warnings and Precautions (5.6) and Drug Interactions (7.1).] A time interval between dosing should be considered when vardenafil hydrochloride tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)] . 4 CONTRAINDICATIONS 4.1 NitratesAdministration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] .

• Vardenafil interacts with certain blood pressure medicines, affecting efficacy.
• The medication can be used by men of most adult age groups.
• Women who are pregnant or breastfeeding should not use vardenafil.
• It’s advisable to avoid grapefruit or grapefruit juice when on vardenafil.
• Always complete your prescribed course even if symptoms improve.
• Seek medical attention if you notice symptoms of allergic reaction.
• Vardenafil is not intended for use by individuals with recent stroke or heart attack.
• Sexual activity may be dangerous for some men with cardiovascular issues.
• The medication is not approved for use in women or children.
• Use caution when combining vardenafil with other erectile dysfunction drugs.

Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. Administration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)] .

14.2 Trial in Patients with ED and Diabetes Mellitus

The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.2.3 Use in Specific PopulationsGeriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)].Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .Renal Impairment: Do not use vardenafil hydrochloride tablets in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].2.4 Concomitant MedicationsNitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)]Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)].CYP3A4 Inhibitors: The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2 )].If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows:Ritonavir: No more than 2.5 mg in a 72-hour period.Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period.Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.Cobicistat: No more than 2.5 mg in a 72 hour period.Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.

Usual Adult Dose for:

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In those patients who are stable on alpha-blocker therapy, vardenafil hydrochloride tablets should be initiated at a dose sex for man tablet of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions (7.1). ]A time interval between dosing should be considered when vardenafil hydrochloride tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)] . For most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity.

Sample Use Guides

Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)]. Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] . 5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.Before prescribing vardenafil hydrochloride tablets, it is important to note the following:5.1 Cardiovascular EffectsGeneralPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatment for erectile dysfunction, including vardenafil hydrochloride tablets, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: 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 the last 6 months); severe cardiac failure.Left Ventricular Outflow ObstructionPatients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic super p force online hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.Blood Pressure EffectsVardenafil hydrochloride tablets have 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) [see Clinical Pharmacology (12.2)] . While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 InhibitorsConcomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Dosage adjustment is necessary when vardenafil hydrochloride tablets are administered with certain CYP3A4 inhibitors [see Dosage and Administration (2.4), and Drug Interactions (7.2)].Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors.5.3 Risk of PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil.

Vardenafil Indications

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.

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Who should not take vardenafil?

In the event that an erection persists longer than 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.Vardenafil hydrochloride tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).5.4 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.