Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Sildenafil is indicated in adult men with 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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in adults
The recommended dose is one 50 mg tablet taken with water approximately one hour before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state.
Special populations
Elderly
Dosage adjustments are not required in elderly patients (≥ 65 years old).
Renal impairment
The dosing recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30 – 80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Hepatic impairment
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary,
Paediatric population
Sildenafil is not indicated for individuals below 18 years of age.
Use in patients taking other medicinal products
With the exception of ritonavir for which co-administration with sildenafil is not advised a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors.
In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered.
Method of administration
For oral use.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed. Levitra orodispersible tablets must be taken without liquid and immediately upon release from the blister.
Levitra orodispersible tablets can be taken with or without food.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).
Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
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