Vigora For Erectile Dysfunction
Composition VIGORA 50
Each film-coated tablet contains Sildenafil Citrate equivalent to Sildenafil.......................50 mg.
Each film-coated tablet contains Sildenafil Citrate equivalent to Sildenafil.......................100 mg.
VIGORA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP] -specific phosphodiesterase type 5 (PPE5). Sildenafil has no direct relaxant effect on secluded human corpus cavemosum, but augments the effect of nitric oxide (NO) by reducing phosphodiesterase type 5 (PDE5), which is in charge for dilapidation of cGMP in the corpus cavemosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by Sildenafil causes increased levels of cGUP in the corpus cavemosum resulting in smooth muscle relaxation and inflow of blood to the corpus covemosum. Sildenafil at suggested doses has no effect in the deficiency of sexual stimulation.
VIGORA, Is indicated for the treatment of erectile dysfunction In men.
Dosage and Administration
For most patients, the recommended dose is 50 mg taken, as needed approximately 1 hour before sexual activity. However, VIGORO may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased 25 mg. The maximum suggested dosing regularity is once per day.
The subsequent factors are connected with augmented plasma levels of Sildenafil; age>65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 00%), severe renal impairment (creatinine clearance <3D ml/min. 100%) and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, 200%) Since higher plasma levels may increase both the effectiveness and occurrence of undesirable events, a starting dose of 25mg should be measured in these patients.
Use of VIGORA is contra indicated in patients with a known hypersensitivity of any component of the tablet. Consistent with its know effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contra indicated.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Sildenafil was not carcinogenic when administered to rats and mice.
No evidence of teraiogenecity, embryotoxicify or fetotoxiclly was observed in animal studies.
There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/dayfor 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the hyriian male AUC.
There was no effect on sperm motility of morphology after single 100 mg oral doses of sildenafil In healthy volunteers.