Studies in vitro have shown that sildenafil is selective for PDE5. Clinical studies: Cardiac: Single oral doses of sildenafil up to mg produced no clinically relevant changes in the ECGs of normal male volunteers. The mean maximum decreases in supine systolic blood pressure following mg oral dosing was 8. The corresponding change in supine diastolic blood pressure was 5.
Larger but similarly transient effects on blood pressure were recorded among patients receiving concomitant nitrates see Contraindications and Interactions. In a double-blind, placebo-controlled trial, patients with erectile dysfunction and stable angina, who were taking their regular antianginal medications except nitrates were exercised until limiting angina occurred. The duration of treadmill exercise was statistically significantly longer The mean exercise times adjusted for baseline to the onset of limiting angina were The incidence of adverse events was consistent with observations in other patient populations, as well as in the subjects taking three or more antihypertensive agents.
The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity, contrast sensitivity, electroretinograms, intraocular pressure, or pupillometry.
Efficacy: The efficacy and safety of sildenafil was evaluated in 21 randomized, double-blind, placebo-controlled trials of up to 6 months duration. Sildenafil was administered to more than patients aged , with ED of various etiologies organic, psychogenic, mixed.
The efficacy was evaluated by global assessment question, diary of erections, the International Index of Erectile Function IIEF, a validated sexual function questionnaire and a partner questionnaire.
Sildenafil efficacy, determined as the ability to achieve and maintain an erection sufficient for sexual intercourse, was demonstrated in all 21 studies and was maintained in long-term extension studies one year. In addition to improvements in erectile dysfunction, analysis of the IIEF showed that sildenafil treatment also improved the domains of orgasm, satisfaction with intercourse and overall satisfaction.
Pharmacokinetics: Sildenafil pharmacokinetics are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism mainly cytochrome P 3A4 and is converted to an active metabolite with properties similar to the parent, sildenafil. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state.
Distribution: The mean steady-state volume of distribution V ss for sildenafil is L, indicating distribution into the tissues. Protein binding is independent of total drug concentrations. Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. The N-desmethyl metabolite is further metabolized, with a terminal half-life of approximately 4 hours.
The pharmacokinetics of sildenafil in patients with severely impaired hepatic function Child-Pugh class C have not been studied. Bacterial and in vivo mutagenicity tests were negative. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers. Sildenafil is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for sildenafil to be effective, sexual stimulation is required. Sildenafil tablets are for oral administration. Use in adults: For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of mg or decreased to 25 mg.
The maximum recommended daily dose is mg. The maximum recommended dosing frequency is once per day. Use in patients with impaired hepatic function: Since sildenafil clearance is reduced in patients with hepatic impairment e. Use in patients using other medications: Given the extent of the interaction with patients receiving concomitant therapy with ritonavir see Interactions , it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a hour period.
A starting dose of 25 mg should be considered in patients receiving concomitant treatment with the CYP3A4 inhibitors e. In order to minimize the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at lower doses should be considered see Precautions and Interactions.
Use in elderly men: Dosage adjustments are not required in elderly patients. In studies with healthy volunteers of single doses up to mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.
Use of sildenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. Sildenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates, and its administration to patients who are concurrently using nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is therefore contraindicated see Interactions.
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