Active substance: Vardenafil
It is not known if vardenafil is excreted in human breast milk. Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma.
Pediatric Use Levitra is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of Levitra 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients.
Hepatic Impairment Dosage adjustment is necessary in patients with moderate hepatic impairment. Do not use Levitra 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. No dosage adjustment is necessary in patients with mild hepatic impairment.
Renal Impairment Do not use Levitra in patients on renal dialysis as vardenafil has not been evaluated in such patients. 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 is not significantly eliminated in the urine. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate cGMP -specific phosphodiesterase type 5 PDE 5.
In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.
Levitra - Clinical Pharmacology Mechanism of Action 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 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.