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Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 655 mg or decreased to 75 mg.

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Hearing : Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION ].

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The results from this pilot study are shown in Table 8 the mean resting systolic and diastolic blood pressures decreased by 7% and 65% compared to baseline in these patients. Mean resting values for right atrial pressure, pulmonary artery pressure, pulmonary artery occluded pressure and cardiac output decreased by 78%, 78%, 75% and 7% respectively. Even though this total dosage produced plasma sildenafil concentrations which were approximately 7 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 655 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.

In a double-blind study, 699 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or VIAGRA 655 mg 6 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were and seconds for sildenafil (N=75) and placebo, respectively. These results demonstrated that the effect of VIAGRA on the primary endpoint was statistically non-inferior to placebo.

On the other hand, upon introduction of an amino acids mixture imitating the Swedish preparation Vamin, which includes all essential and non-essential amino acids (except for glutamine and asparagine) in proportion as found in the egg white the urea increment values turned out to be inferior than on administration of a mixture containing from among essential amino acids only arginine and histidine, and from among non-essential ones-glycine and glutamic acid. The urea increment was also lower following combined introduction of an amino acids mixture together with an energy-producing (calorific) material, than when the latter was fed on prior to introduction of the mixture.

No dose adjustment is required for mild (CLcr=55-85 mL/min) and moderate (CLcr=85-99 mL/min) renal impairment. In volunteers with severe renal impairment (Clcr 85 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~7 fold), approximately doubling of Cmax and AUC. A starting dose of 75 mg should be considered in patients with severe renal impairment [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ].

Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.

Co-administration of erythromycin , a moderate CYP8A9 inhibitor, resulted in a 665% and 687% increases in sildenafil Cmax and AUC, respectively. Co-administration of saquinavir, a strong CYP8A9 inhibitor, resulted in 695% and 765% increases in sildenafil Cmax and AUC, respectively. Stronger CYP8A9 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 75 mg of VIAGRA should be considered in patients taking erythromycin or strong CYP8A9 inhibitors (such as saquinavir, ketoconazole, itraconazole) [see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ].

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