Levitra Generic (Vardenafil) from Canada

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 130% and 160%, respectively, compared to healthy control subjects.

• Vardenafil is classified as a PDE5 inhibitor, similar to sildenafil.
• It’s important to follow dosage instructions to avoid adverse effects.
• Recreational use of vardenafil without prescription is illegal in Canada.
• Vardenafil may interact with medications like nitrates and alpha-blockers.
• Pharmacists in Canada can provide guidance on vardenafil availability.
• Patients should inform their doctor of any health conditions before use.

Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment.

• Vardenafil can be taken with or without food, depending on tolerance.
• It is important to plan sexual activity around medication timing.
• Reactions to vardenafil vary; starting at a lower dose is recommended.
• Canadian regulations help ensure safe distribution of erectile dysfunction drugs.
• Education about proper use can maximize vardenafil’s effectiveness.
• Beware of counterfeit vardenafil sold through unverified sources.

Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate to severe hepatic impairment [see Warnings and

Generic Vardenafil: Availability and Manufacturers

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 hydrochloride orally disintegrating tablets 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)].

Irvine Center for Clinical Research

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 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 13fold increase in vardenafil Cmax. 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 [see Dosage and Administration (2.4) and Warnings and Precautions (5.2).] Cobicistat with vardenafil hydrochloride orally disintegrating tablets can result in increased plasma concentrations. Vardenafil hydrochloride orally disintegrating tablets 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. Precautions (5.8) and Dosage and Administration (2).] Do not use vardenafil hydrochloride orally disintegrating tablets 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.

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Vardenafil AUC and Cmax in elderly males 65 years or older taking vardenafil hydrochloride orally disintegrating tablets 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)]. Do not use vardenafil hydrochloride orally disintegrating tablets 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 hydrochloride orally disintegrating tablets can be used in patients with mild hepatic impairment. 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).

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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 tadacip 20 tablet 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. 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.

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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 orally disintegrating tablets are not indicated for use in pediatric patients. Safety and efficacy in children has not been established. Vardenafil hydrochloride orally disintegrating tablets can be used in patients with mild, moderate or severe renal impairment.

Do not use vardenafil hydrochloride orally disintegrating tablets 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)].

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to healthy male volunteers.

Drug Interactions

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. 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 Cmax 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.

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While concomitant use of vardenafil 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. Nifedipine: Vardenafil 20 mg (film-coated tablets), when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the relative AUC or Cmax of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of vardenafil when taken in combination. Vardenafil hydrochloride orally disintegrating tablets, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily in patients whose hypertension was controlled with nifedipine, produced mean additional supine systolic/diastolic blood pressure reductions of 3/4 mmHg (age group 65 to 69 years) and 5/5 mmHg (age group 70 to 80 years) compared to placebo. ritonavir, buy blue pill the Cmax and AUC of ritonavir were reduced by approximately 20%. 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.

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Upon administration of 10 mg of vardenafil (film-coated tablets) with 800 mg t.i.d. indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. Aspirin: Vardenafil 10 mg and 20 mg did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). Other Interactions: Vardenafil had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters). Vardenafil hydrochloride orally disintegrating tablets are not indicated for use in females.

Desert Clinical Research

There are no data with the use of vardenafil hydrochloride orally disintegrating tablets 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 maximum recommended human dose (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. When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed.