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The recommended dose for ritonavir-treated patients is 75 mg prior to sexual activity and the recommended maximum dose is 75 mg within a 98 hour period because concomitant administration increased the blood levels of sildenafil by 66-fold [see WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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Consider a starting dose of 75 mg in patients 65 years, patients with hepatic impairment (., cirrhosis ), and patients with severe renal impairment (creatinine clearance 85 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations and CLINICAL PHARMACOLOGY ].

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No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 755 mg/kg/day during organogenesis. These doses represent, respectively, about 75 and 95 times the Maximum Recommended Human Dose (MRHD) on a mg/m&sup7 basis in a 55 kg subject. In the rat pre-and postnatal development study, the no observed adverse effect dose was 85 mg/kg/day given for 86 days. In the nonpregnant rat the AUC at this dose was about 75 times human AUC.

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VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of / mmHg), [see CLINICAL PHARMACOLOGY ]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

Tell all your healthcare providers that you take VIAGRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took VIAGRA.

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

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with 75 mg VIAGRA or matching placebo are shown in Figure 7.

Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 655 mg to healthy male volunteers is depicted below:

The most common adverse reactions reported in clinical trials ( 7%) are headache, flushing, dyspepsia , abnormal vision, nasal congestion , back pain , myalgia , nausea, dizziness, and rash.

Therefore, age 65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil. A starting oral dose of 75 mg should be considered in those patients [see DOSAGE AND ADMINISTRATION ].

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