DOSAGE AND ADMINISTRATION

The drug interaction studies described below were conducted using vardenafil film-coated tablets. Nitrates: Concomitant use of vardenafil orally disintegrating tablet and nitrates is contraindicated. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of vardenafil orally disintegrating tablet and nitrates is contraindicated [see Contraindications (4.1) and Clinical Pharmacology (12.2)].

In case of emergency/overdose

Alpha-Blockers: Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil orally disintegrating tablet. [See Dosage and Administration (2.4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2).] Antihypertensives: Vardenafil orally disintegrating tablet may add to the blood pressure lowering effect of antihypertensive agents. Alcohol: Vardenafil 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.

• Consumers should avoid alcohol when using liquid Levitra.
• Do not exceed the prescribed dose to prevent side effects.
• Keep out of reach of children due to potential misuse.

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)]. Do not use vardenafil orally disintegrating tablet with moderate and strong CYP3A4 inhibitors such as erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir as the systemic concentration of vardenafil is increased in their presence [see Warnings and Precautions (5) and Dosage and Administration (2.4)].

• The safety of liquid Levitra has been studied in clinical trials.
• It provides a discreet and easy way to manage ED.
• Regular check-ups are recommended during use.

Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil area under the curve (AUC) and a 4-fold increase in maximum concentration (Cmax) when co-administered with vardenafil 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 levitra woman vardenafil 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil Cmax and a 2-fold increase in vardenafil half-life.

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Safety and efficacy in children has not been established.8.5 Geriatric UseVardenafil AUC and Cmax in elderly males 65 years or older taking vardenafil orally disintegrating tablet were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences in safety or effectiveness were observed between patients ≥65 years old and those < 65 years old in placebo-controlled clinical trials [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentDo not use vardenafil orally disintegrating tablet in patients with moderate or severe hepatic impairment.In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 22% and 17%, respectively, compared to healthy control subjects. Vardenafil orally disintegrating tablet can be used in patients with mild hepatic impairment. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by price levitra 10mg 130% and 160%, respectively, compared to healthy control subjects. Do not use vardenafil orally disintegrating tablet in patients with moderate to severe hepatic impairment.

Possible Side Effects While Using This Medicine:

[See Warnings and Precautions (5.8) and Dosage and Administration (2). ]8.7 Renal ImpairmentDo not use vardenafil orally disintegrating tablet in patients on renal dialysis.In volunteers with mild renal impairment (CLcr = 50 to 80 mL/min), the pharmacokinetics of vardenafil 20 mg film-coated tablets were similar to those observed in a control group with normal renal function. In the moderate (CLcr = 30 to 50 mL/min) or severe (CLcr <30 mL/min) renal impairment groups, the AUC of vardenafil was 20 to 30% higher compared to that observed in a control group with normal renal function (CLcr >80 mL/min). Vardenafil orally disintegrating tablet can be used in patients with mild, moderate or severe renal impairment. Do not use vardenafil orally disintegrating tablet in patients on renal dialysis as vardenafil has not been evaluated in such patients [see Dosage and Administration (2.3) and Warnings and Precautions (5.9)].

Pregnancy Categories

Vardenafil orally disintegrating tablet is not indicated for use in females. There are no data with the use of vardenafil orally disintegrating tablet in pregnant women to inform any drug-associated risks. 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. [See Dosage and Administration (2.4) and Warnings and Precautions (5).] Ritonavir (600 mg b.i.d.) co-administered with vardenafil 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13-fold increase in vardenafil Cmax.

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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. There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the 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.

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Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours.

Pulmonary Arterial Hypertension (Orphan)

[See Dosage and Administration (2.4) and Warnings and Precautions (5.2).] Cobicistat with vardenafil can result in increased plasma concentrations. vardenafil should not be used with cobicistat. Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in vardenafil Cmax when co-administered with vardenafil 5 mg in healthy volunteers [see Dosage and Administration (2) and Warnings and Precautions (5)].

No 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.

Further information

The drug interaction studies described below were conducted using vardenafil film-coated tablets. Nitrates: Concomitant use of vardenafil orally disintegrating tablet and nitrates is contraindicated. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of vardenafil orally disintegrating tablet and nitrates is contraindicated [see Contraindications (4.1) and Clinical Pharmacology (12.2)]. Alpha-Blockers: Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil orally disintegrating tablet. [See Dosage and Administration (2.4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2).] Antihypertensives: Vardenafil orally disintegrating tablet may add to the blood pressure lowering effect of antihypertensive agents.

Drugs and Foods to Avoid:

Alcohol: Vardenafil 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. 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)]. Do not use vardenafil orally disintegrating tablet with moderate and strong CYP3A4 inhibitors such as erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir as the systemic concentration of vardenafil is increased in their presence [see Warnings and Precautions (5) and Dosage and Administration (2.4)].

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Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil area under the curve (AUC) and a 4-fold increase in maximum concentration (Cmax) when co-administered with vardenafil 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 levitra woman vardenafil 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil Cmax and a 2-fold increase in vardenafil half-life. [See Dosage and Administration (2.4) and Warnings and Precautions (5).] Ritonavir (600 mg b.i.d.) co-administered with vardenafil 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13-fold increase in vardenafil Cmax. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2).] Cobicistat with vardenafil can result in increased plasma concentrations. vardenafil should not be used with cobicistat. Cimetidine (400 mg b.i.d.) had no effect on AUC and Cmax of vardenafil when co-administered with 20 mg vardenafil in healthy volunteers. In vitro data suggest that vardenafil has the potential to inhibit P-glycoprotein (P-gp) at therapeutic doses. indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryVardenafil orally disintegrating tablet is not indicated for use in females.There are no data with the use of vardenafil orally disintegrating tablet in pregnant women to inform any drug-associated risks. 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).DataAnimal DataNo 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 levitra cut price 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.

• Liquid Levitra is often preferred for its ease of swallowing.
• It may be used when swallowing pills is difficult.
• Proper storage preserves its potency.

Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. The number of living pups born to rats exposed pre-and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre-and postnatal study, the developmental NOAEL is less than 1 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.8.2 LactationRisk SummaryVardenafil orally disintegrating tablet is not indicated for use in females.There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Vardenafil is present in rat milk of lactating rats (see Data).DataVardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma.

5.6 Alpha-Blockers

Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in vardenafil Cmax when co-administered with vardenafil 5 mg in healthy volunteers [see Dosage and Administration (2) and Warnings and Precautions (5)]. No 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 AUC and Cmax of vardenafil when co-administered with 20 mg vardenafil in healthy volunteers. In vitro data suggest that vardenafil has the potential to inhibit P-glycoprotein (P-gp) at therapeutic doses.

Hormonal changes

indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryVardenafil orally disintegrating tablet is not indicated for use in females.There are no data with the use of vardenafil orally disintegrating tablet in pregnant women to inform any drug-associated risks. 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).DataAnimal DataNo 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 levitra cut price 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. Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk.

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The number of living pups born to rats exposed pre-and postnatally was reduced at 60 mg/kg/day. Based on the results of the pre-and postnatal study, the developmental NOAEL is less than 1 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.8.2 LactationRisk SummaryVardenafil orally disintegrating tablet is not indicated for use in females.There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Vardenafil is present in rat milk of lactating rats (see Data).DataVardenafil 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.8.4 Pediatric UseVardenafil orally disintegrating tablet is not indicated for use in pediatric patients. Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours.8.4 Pediatric UseVardenafil orally disintegrating tablet is not indicated for use in pediatric patients. Safety and efficacy in children has not been established.8.5 Geriatric UseVardenafil AUC and Cmax in elderly males 65 years or older taking vardenafil orally disintegrating tablet were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences in safety or effectiveness were observed between patients ≥65 years old and those < 65 years old in placebo-controlled clinical trials [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentDo not use vardenafil orally disintegrating tablet in patients with moderate or severe hepatic impairment.In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 22% and 17%, respectively, compared to healthy control subjects.

7.3 Effects of Vardenafil on Other Drugs

Vardenafil orally disintegrating tablet can be used in patients with mild hepatic impairment. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by price levitra 10mg 130% and 160%, respectively, compared to healthy control subjects. Do not use vardenafil orally disintegrating tablet in patients with moderate to severe hepatic impairment. [See Warnings and Precautions (5.8) and Dosage and Administration (2). ]8.7 Renal ImpairmentDo not use vardenafil orally disintegrating tablet in patients on renal dialysis.In volunteers with mild renal impairment (CLcr = 50 to 80 mL/min), the pharmacokinetics of vardenafil 20 mg film-coated tablets were similar to those observed in a control group with normal renal function. In the moderate (CLcr = 30 to 50 mL/min) or severe (CLcr <30 mL/min) renal impairment groups, the AUC of vardenafil was 20 to 30% higher compared to that observed in a control group with normal renal function (CLcr >80 mL/min). Vardenafil orally disintegrating tablet can be used in patients with mild, moderate or severe renal impairment. Do not use vardenafil orally disintegrating tablet in patients on renal dialysis as vardenafil has not been evaluated in such patients [see Dosage and Administration (2.3) and Warnings and Precautions (5.9)]. Vardenafil orally disintegrating tablet is not indicated for use in females. There are no data with the use of vardenafil orally disintegrating tablet in pregnant women to inform any drug-associated risks. 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.

• The onset of action may vary between individuals.
• Sexual stimulation is necessary for effectiveness.
• Use on an empty stomach may result in quicker action.

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. There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the 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.