It Is IndIcated for the treatment of erectIle dysfunctIon.
phosphodiesterase (PDE) inhibitors
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). Penile 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 in the corpus cavernosum & 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 an erection. 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.
For most patients, the recommended starting dose of It is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. It can be taken with or without food. Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg It should be considered in patients ?65 years of age . Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of It is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg It is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. It has not been evaluated in patients with severe hepatic impairment (Child-Pugh C)
Vardenafil can potentiate the blood pressure lowering effect of antihypertensive agents. In clinical studies, single doses of Vardenafil 20 mg caused a mean decrease in blood pressure of 7 mmHg systolic and 8 mmHg diastolic. Caution should be taken when co-administered with other vasodilators including alpha blockers. Vardenafil does not potentiate the hypotensive effect of alcohol. CYP3A4 inhibitors (ketoconazole, indinavir, ritonavir and erythromycin) may reduce Vardenafil excretion from body
Administration of It with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates. A suitable time interval following It dosing for the safe administration of nitrates or nitric oxide donors has not been determined. Hypersensitivity: It is contraindicated for patients with a known hypersensitivity to any component of the tablet.
headache, flushing (warmth or redness in your face, neck, or chest), runny or stuffy nose, stomach upset, heartburn, dizziness, back pain, or. nausea.
It is not indicated for use in women, newborns, or children. 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. It is not known if vardenafil is excreted in human breast milk. Pregnancy Category B: 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. 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. There are no adequate and well-controlled trials of vardenafil in pregnant women.
The maximum dose of Vardenafil for which human data are available is a single 120 mg. Where the majority of these subjects experienced blurred vision and back pain. Single doses up to 80 mg and multiple doses up to 40 mg administered once daily over 4 weeks did not show serious adverse effects. In cases of overdose, contact with the doctor immediately.
Store at room temperature and protect from light and moisture. Keep out of the reach of children.
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