DRUG INTERACTIONS

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentDosage adjustment is necessary in patients with moderate hepatic impairment.Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population.A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg. In volunteers with moderate hepatic impairment, the C max and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. [See Warnings and Precautions (5.8) and Dosage and Administration (2.3). ]In volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects.

See also:

Vardenafil hydrochloride tablets are not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean C max and AUC were 34% and 52% higher, respectively. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)]. Dosage adjustment is necessary in patients with moderate hepatic impairment.

Mechanism of Action

Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population. A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg. [See Warnings and Precautions (5.8) and Dosage and Administration (2.3).] In volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment. No dosage adjustment is necessary in patients with mild hepatic impairment.8.7 Renal ImpairmentDo not use vardenafil hydrochloride tablets in patients on renal dialysis as vardenafil has not been evaluated in such patients.No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min. In male volunteers with CLcr = 50-80 ml/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min.

In male volunteers with CLcr = 30-50 mL/min or CLcr <30 mL/min, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr >80 mL/min.

How should this medicine be used?

In cases of overdose, standard supportive measures should be taken as required. 11 DESCRIPTION Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally 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 structural formula:Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. 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 structural formula: Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.

Still not finding the right product?

Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of ActionPenile 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. [See Dosage and Administration (2.3) and Warnings and Precautions (5.9).] Vardenafil hydrochloride tablets are not indicated for use in females.

8.5 Geriatric Use

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).12.2 PharmacodynamicsEffects on Blood PressureIn 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. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see Drug Interactions (7)] .Effects on Blood Pressure and Heart Rate when Vardenafil Hydrochloride Tablets are Combined with NitratesA study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with vardenafil hydrochloride tablets 20 mg at various times before NTG administration.

CNS Activity

There are no data with the use of vardenafil hydrochloride tablets in pregnant women to inform any drug-associated risks.

5.13 Risks in Patients with Phenylketonuria

In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD) of 20 mg based on AUC (see Data). No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the MRHD of 20 mg. In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg.

Who should not take vardenafil?

Vardenafil hydrochloride tablets are not indicated for use in females. There is no information on the presence of vardenafil and tadalista professional its major metabolite in human milk, the effects on breastfed infant, or the effects on milk production. Vardenafil is present in rat milk of lactating rats (see Data). Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD) of 20 mg based on AUC (see Data). No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis.

• Vardenafil HCl 10mg is effective for most men within 30-60 minutes.
• The duration of effect can last up to 4-5 hours.
• Do not take more than one dose per 24 hours to prevent overdose.
• Vardenafil does not cause an erection without sexual stimulation.
• It’s not a cure for erectile dysfunction but manages symptoms temporarily.
• Men with penile deformities or prior surgeries should consult a doctor before use.
• Side effects are usually mild but consult if they worsen or persist.
• Vardenafil is metabolized in the liver, so dose adjustments may be needed.
• Avoid heavy physical activity immediately after taking the medication.
• Regular check-ups are recommended to monitor health while on vardenafil.

This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the MRHD of 20 mg. In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. Vardenafil hydrochloride tablets are not indicated for use in females. There is no information on the presence of vardenafil and tadalista professional its major metabolite in human milk, the effects on breastfed infant, or the effects on milk production. Vardenafil is present in rat milk of lactating rats (see Data). Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. Vardenafil hydrochloride tablets are not indicated for use in pediatric patients.

Safety and efficacy have not been established in this population. Elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean C max and AUC were 34% and 52% higher, respectively. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)]. Dosage adjustment is necessary in patients with moderate hepatic impairment. Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population. A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg.

• Vardenafil HCl 10mg improves erectile response by increasing blood flow.
• Avoid combining it with other ED medications unless prescribed.
• Potential for interactions with certain heart and blood pressure medicines.
• Use vardenafil with caution under doctor supervision if you have health issues.
• It’s not suitable for women, children, or individuals without ED diagnosis.
• Store in a cool, dry place away from direct sunlight.
• Do not take if you recently used nitric oxide donors.
• Be mindful of timing; take about an hour before intimacy.
• The medication does not produce an erection without sexual stimulation.
• Always adhere to your prescribed dose for best results.

[See Warnings and Precautions (5.8) and Dosage and Administration (2.3).] In volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment. Do not use vardenafil hydrochloride tablets in patients on renal dialysis as vardenafil has not been evaluated in such patients.

2.4 Concomitant Medications

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentDosage adjustment is necessary in patients with moderate hepatic impairment.Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population.A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg. In volunteers with moderate hepatic impairment, the C max and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. [See Warnings and Precautions (5.8) and Dosage and Administration (2.3). ]In volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects.

Incidence not known

No dosage adjustment is necessary in patients with mild hepatic impairment.8.7 Renal ImpairmentDo not use vardenafil hydrochloride tablets in patients on renal dialysis as vardenafil has not been evaluated in such patients.No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min. In male volunteers with CLcr = 50-80 ml/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min. In male volunteers with CLcr = 30-50 mL/min or CLcr <30 mL/min, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr >80 mL/min. [See Dosage and Administration (2.3) and Warnings and Precautions (5.9).] Vardenafil hydrochloride tablets are not indicated for use in females. There are no data with the use of vardenafil hydrochloride tablets in pregnant women to inform any drug-associated risks. No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min.

Available Strengths & Forms

[See Dosage and Administration (2.3) and Warnings and Precautions (5.9).] 10 OVERDOSAGE The maximum dose of vardenafil hydrochloride tablets for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or "abnormal vision." Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed.

Proper Use

Do not use vardenafil hydrochloride tablets in patients on renal dialysis as vardenafil has not been evaluated in such patients. No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min. [See Dosage and Administration (2.3) and Warnings and Precautions (5.9).] 10 OVERDOSAGE The maximum dose of vardenafil hydrochloride tablets for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or "abnormal vision." Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological toxicity was identified.In cases of overdose, standard supportive measures should be taken as required.

Professional resources

Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine. The maximum dose of vardenafil hydrochloride tablets for which human data are available is a single 120 mg dose administered to healthy male volunteers. Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects. When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological buy cenforce pills toxicity was identified. No muscle or neurological toxicity was identified.In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine. The maximum dose of vardenafil hydrochloride tablets for which human data are available is a single 120 mg dose administered to healthy male volunteers. Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects. When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological buy cenforce pills toxicity was identified. In cases of overdose, standard supportive measures should be taken as required. 11 DESCRIPTION Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally 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 structural formula:Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. 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 structural formula: Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of ActionPenile 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).12.2 PharmacodynamicsEffects on Blood PressureIn 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. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see Drug Interactions (7)] .Effects on Blood Pressure and Heart Rate when Vardenafil Hydrochloride Tablets are Combined with NitratesA study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with vardenafil hydrochloride tablets 20 mg at various times before NTG administration.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.