Label: VARDENAFIL HYDROCHLORIDE tablet

[See Dosage and Administration (2.4) and Warnings

• Vardenafil 10mg should be used only under medical supervision.
• Overdose may cause serious side effects like priapism or sudden vision loss.
• The medication is available by prescription and not for recreational use.
• Male patients with heart issues should consult a doctor before use.
• Vardenafil may interact with other medications like antibiotics or antifungals.
• Alcohol consumption can increase the risk of side effects when taking vardenafil.
• It’s important to follow the prescribed dosage strictly for safety.
• Use caution if you have liver or kidney problems while taking vardenafil.
• Women and children should avoid using vardenafil, as it's designed for men.
• Discuss all health conditions and medications with your healthcare provider first.

and Precautions (5).] Although specific interactions have

• 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.

not been studied, other CYP3A4 inhibitors, including

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

Nitrates: Concomitant use of vardenafil hydrochloride tablets and nitrates and nitric oxide donors is contraindicated. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of vardenafil hydrochloride tablets and nitrates is contraindicated [see Contraindications (4.1) and Clinical Pharmacology (12.2). [See Dosage and Administration (2.4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2).] Antihypertensives: Vardenafil hydrochloride tablets may add to the blood pressure lowering effects of antihypertensive agents. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1. Alcohol: Vardenafil hydrochloride tablets (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight, approximately 40 mL of absolute alcohol in a 70 kg person).

Other Interactions

Alcohol and vardenafil plasma levels were not altered when dosed simultaneously. Studies in human liver microsomes showed that vardenafil is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9. Therefore, inhibitors of these enzymes are expected to reduce vardenafil clearance [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)] . Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max) when co-administered with vardenafil hydrochloride tablets (5 mg) in healthy volunteers. [See Dosage and Administration (2.4) and Warnings and Precautions (5).] Indinavir (800 mg t.i.d.) co-administered with vardenafil hydrochloride tablets 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil C max and a 2-fold increase in vardenafil half-life. grapefruit juice would likely increase vardenafil exposure.

No pharmacokinetic interactions were observed between vardenafil and the following drugs:

• 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.

glyburide, warfarin, digoxin, an antacid

based on magnesium-aluminum hydroxide, and ranitidine.

Usual Geriatric Dose for Erectile Dysfunction

Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. [See Dosage and Administration (2.4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2). ]Antihypertensives: Vardenafil hydrochloride tablets may add to the blood pressure lowering effects of antihypertensive agents. In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing.

Pharmacological Class

Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1.Alcohol: Vardenafil hydrochloride tablets (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight, approximately 40 mL of absolute alcohol in a 70 kg person). Alcohol and vardenafil plasma levels were not altered when dosed simultaneously.7.2 Effect of Other Drugs on VardenafilIn vitro studiesStudies in human liver microsomes showed that vardenafil is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9. Therefore, inhibitors of these enzymes are expected to reduce vardenafil clearance [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)] .In vivo studiesStrong CYP3A4 inhibitorsKetoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max) when co-administered with vardenafil hydrochloride tablets (5 mg) in healthy volunteers. A 5-mg vardenafil hydrochloride tablet dose should not be exceeded in a 24-hour period when used in combination with 200 mg once daily ketoconazole. Since higher doses of ketoconazole (400 mg daily) may result in higher increases in C max and AUC, a single 2.5 mg dose of vardenafil hydrochloride tablets should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily.

Storage Class

[See Dosage and Administration (2.4) and Warnings and Precautions (5). ]Indinavir (800 mg t.i.d.) co-administered with vardenafil hydrochloride tablets 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil C max and a 2-fold increase in vardenafil half-life. It is recommended not to exceed a single 2.5 mg vardenafil hydrochloride tablets dose in a 24-hour period when used in combination with indinavir. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2). ]Ritonavir (600 mg b.i.d.) co-administered with vardenafil hydrochloride tablets 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13 fold increase in vardenafil C max. In the warfarin study, vardenafil had no effect

• 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.

on the prothrombin time or other pharmacodynamic parameters.

The most potent inhibitory activity was observed for vardenafil

5.11 Effects on Bleeding

The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a HIV protease inhibitor and a highly strong CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. Consequently, it is recommended not to exceed a single 2.5 mg vardenafil hydrochloride tablets dose in a 72-hour period when used in combination with ritonavir. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2).] .Cobicistat with vardenafil hydrochloride tablets can result in increased plasma concentrations, therefore it is recommended that a single 2.5 mg dose of vardenafil hydrochloride tablets should not be exceeded in a 72-hour period. [See Dosage and Administration (2.4) and Warnings and Precautions (5).] .Moderate CYP3A4 inhibitorsErythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in C max when co administered with vardenafil hydrochloride tablets 5 mg in healthy volunteers.

Can vardenafil treat all forms of ED?

It is recommended not to exceed a single 5 mg dose of vardenafil hydrochloride tablets in a 24-hour period when used in combination with erythromycin. ]Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure.Other Drug InteractionsNo pharmacokinetic interactions were observed between vardenafil and the following drugs: glyburide, warfarin, digoxin, an antacid based on magnesium-aluminum hydroxide, and ranitidine. In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters.Cimetidine (400 mg b.i.d.) had no effect on vardenafil bioavailability (AUC) and maximum concentration (C max) of vardenafil when co-administered with 20 mg vardenafil hydrochloride tablets in healthy volunteers.7.3 Effects of Vardenafil on Other DrugsIn vitro studiesVardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar). Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 C max values after an 80 mg vardenafil dose.In vitro data suggest that vardenafil has the potential to inhibit P-glycoprotein (P-gp) at therapeutic doses.

SMILES string

While concomitant use of sex tablet for women vardenafil hydrochloride tablets did not significantly increase plasma concentrations of digoxin, a P-gp substrate, the effect on plasma concentrations of P-gp substrates that are more sensitive than digoxin (e.g. dabigatran) is not known.In vivo studiesNifedipine: Vardenafil 20 mg, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the AUC or C max of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of vardenafil hydrochloride tablets when taken in combination. In these patients whose hypertension was controlled with nifedipine, vardenafil hydrochloride tablets 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo.Ritonavir and Indinavir: Upon concomitant administration of 5 mg of vardenafil hydrochloride tablets with 600 mg BID ritonavir, the C max and AUC of ritonavir were reduced by approximately 20%. Upon administration of 10 mg of vardenafil hydrochloride tablets with 800 mg TID indinavir, the C max and AUC of indinavir were reduced by 40% and 30%, respectively. metabolite M1, which had a Ki of 1.4 micromolar toward

CYP3A4, which is about 20 times higher than the

8.6 Hepatic Impairment

[See Dosage and Administration (2.4) and Warnings and Precautions (5.2).] Ritonavir (600 mg b.i.d.) co-administered with vardenafil hydrochloride tablets 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13 fold increase in vardenafil C max. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2).]. Cobicistat with vardenafil hydrochloride tablets can result in increased plasma concentrations, therefore it is recommended that a single 2.5 mg dose of vardenafil hydrochloride tablets should not be exceeded in a 72-hour period. [See Dosage and Administration (2.4) and Warnings and Precautions (5).]. Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in C max when co administered with vardenafil hydrochloride tablets 5 mg in healthy volunteers. M1 C max values after an 80 mg vardenafil dose.