Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including vardenafil hydrochloride tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride tablets, for this uncommon condition.Vardenafil hydrochloride tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.5.5 Sudden Hearing LossPhysicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek prompt medical attention in the 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 the intake of PDE5 inhibitors, including vardenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)].5.6 Alpha-BlockersCaution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including vardenafil hydrochloride tablets, 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 (for example, fainting) [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)] . Consideration should be given to the following: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 inhibitors.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose [see Dosage and Administration (2.4)] .In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.5.7 Congenital or Acquired QT ProlongationIn a study of the effect of vardenafil hydrochloride tablets on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)] , therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval.

5.11 Effects on Bleeding

[See Dosage and Administration (2.3) Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)].5.9 Renal ImpairmentDo not use vardenafil hydrochloride tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].5.10 Combination with Other Erectile Dysfunction TherapiesThe safety and efficacy of vardenafil hydrochloride tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.5.11 Effects on BleedingIn humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is vardenafil premature ejaculation no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil hydrochloride tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore vardenafil hydrochloride tablets should be administered to these patients after careful benefit-risk assessment.5.12 Sexually Transmitted DiseaseThe use of vardenafil hydrochloride tablets offers no protection against sexually transmitted diseases.

Adverse Reactions

Vardenafil dosing information

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. There 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. 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).

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

Physicians 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. 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. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)] .

Patient resources

Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride tablets, for this uncommon condition. Vardenafil hydrochloride tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients. There is vardenafil premature ejaculation no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil hydrochloride tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration.

Country	Approval Status	Regulatory Body	Notes
USA	Approved (FDA)	FDA	Prescription-only medication
European Union	Approved (EMA)	EMA	Prescription medication
Canada	Approved	Health Canada	Prescription-only
Australia	Approved	TGA	Prescription medication

Therefore vardenafil hydrochloride tablets should be administered to these patients after careful benefit-risk assessment.5.12 Sexually Transmitted DiseaseThe use of vardenafil hydrochloride tablets offers no protection against sexually transmitted diseases.

Vardenafil Dosage and Administration

Less common

Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.5.13 Risks in Patients with PhenylketonuriaPhenylalanine can be harmful to patients with phenylketonuria (PKU). Vardenafil hydrochloride tablets contain phenylalanine, a component of aspartame. Before prescribing vardenafil hydrochloride tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including vardenafil hydrochloride tablets. 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: Physicians 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.

What special dietary instructions should I follow?

Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic vardenafil pills hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.

14.2 Trial in Patients with ED and Diabetes Mellitus

CNS Activity

PDE5 inhibitors, including vardenafil hydrochloride tablets, 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 (for example, fainting) [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)] . Consideration should be given to the following: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 inhibitors.In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose [see Dosage and Administration (2.4)] .In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.

Biochem/physiol Actions

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.5.7 Congenital or Acquired QT ProlongationIn a study of the effect of vardenafil hydrochloride tablets on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)] , therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining vardenafil hydrochloride tablets with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone [see Clinical Pharmacology (12.2)] . These observations should be considered in clinical decisions when prescribing vardenafil hydrochloride tablets to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride tablets.5.8 Hepatic ImpairmentDosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use vardenafil hydrochloride tablets in patients with severe (Child-Pugh C) hepatic impairment. Vardenafil 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. 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)].

Vardenafil 10mg is available by prescription only, ensure your doctor’s approval.
It is intended for use in adult men diagnosed with erectile dysfunction.
Be cautious with dosing if you have kidney or liver problems.
Remember that sexual activity carries health risks for some men.
Report any adverse effects, especially chest pain or prolonged erections.
It’s important to discuss your complete medical history before use.
The medication does not protect against sexually transmitted infections.
Do not share your medication with others to prevent misuse.
Use vardenafil only as directed to avoid potential health hazards.
Pharmacist or doctor can clarify any questions about proper use.

Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. There 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 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.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Vardenafil (Generic Levitra®) FAQs

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). Physicians 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. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥50.

Vardenafil 10mg is used primarily to improve erectile function in men.
It’s important to avoid taking multiple doses in a 24-hour period.
The tablet should be taken with water, not crushed or chewed.
Potential side effects include headache, flushing, and indigestion.
Rare but serious reactions include sudden vision or hearing loss.
Consult your doctor immediately if adverse reactions occur.
Men with certain health conditions should undergo evaluation before use.
The drug works by relaxing blood vessels to increase blood flow.
Avoid excessive alcohol consumption while on vardenafil.
Store away from light, moisture, and away from children’s reach.

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. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)] . Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride tablets, for this uncommon condition. Vardenafil hydrochloride tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.

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Drug Class	Interaction Type	Effect	Recommendation
Nitrates	Additive hypotension	Risk of severe low blood pressure	Do not combine
CYP3A4 inhibitors	Increased Vardenafil levels	Potential side effects	Adjust dosage if necessary
Alpha-blockers	Enhanced hypotensive effect	Dizziness, fainting	Use with caution
Alpha-adrenergic agents	Blood pressure changes	Fluctuations in BP	Monitor blood pressure closely

Point	Explanation	Additional Advice
Take as prescribed	Usually 10 mg about 30-60 min before activity	Do not exceed recommended dose
Food interactions	High-fat meals may delay onset	Take on an empty stomach or low-fat meal
Alcohol consumption	May decrease effectiveness or increase side effects	Limit alcohol intake
Report side effects or adverse reactions	Such as vision changes, pain, prolonged erections	Seek medical attention immediately

Label: VARDENAFIL HYDROCHLORIDE tablet