- Approval Id
- 918ca62bce287590
- Drug Name
- SILCAP® 50 CAPSULE 50MG
- Product Name
- SILCAP® 50 CAPSULE 50MG
- Approval Number
- SIN16024P
- Approval Date
- 2020-10-09
- Registrant
- IX BIOPHARMA LTD
- Licence Holder
- IX BIOPHARMA LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>Posology and method of administration</strong><br>
Sildenafil capsules are for oral administration.</p>
<p><strong>Use in Adults</strong></p>
<p>For most patients, the recommended dose is 50 mg taken, as needed approximately 1 hour before sexual activity.</p>
<p>Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended daily dose is 100 mg. The maximum recommended dosing frequency is once per day.</p>
<p><strong>Use in Patients with Impaired Renal Function</strong></p>
<p>Dosage adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance = 30 – 80 mL/min).</p>
<p>Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min), a 25 mg dose should be considered.</p>
<p><strong>Use in Patients with Impaired Hepatic Function</strong></p>
<p>Since sildenafil clearance is reduced in patients with hepatic impairment (e.g., cirrhosis), a 25 mg dose should be considered.</p>
<p><strong>Use in Patients using Other Medications</strong></p>
<p>Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see INTERACTIONS WITH OTHER MEDICINES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), co-administration with ritonavir is not advised. If ritonavir is co-administered with sildenafil, it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48-hour period.</p>
<p>A starting dose of 25 mg should be considered in patients receiving concomitant treatment with the CYP3A4 inhibitors (e.g., erythromycin, saquinavir, ketoconazole, itraconazole). See INTERACTIONS WITH OTHER MEDICINES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>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 WITH OTHER MEDICINES – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Use in Children</strong></p>
<p>Sildenafil is not indicated for use in children (<18 years old).</p>
<p><strong>Use in Elderly Men</strong></p>
<p>Since sildenafil clearance is reduced in elderly patients, a first dose of 25 mg should be considered.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS</strong></p>
<p>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.</p>
<p>In order for sildenafil to be effective, sexual stimulation is required.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Use of sildenafil is contraindicated in patients with known hypersensitivity to any component of the capsule.</p>
<p><strong>Nitrates and sildenafil must not be used concomitantly. Sildenafil was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration and therefore, its co-administration with NO donors, organic nitrates or organic nitrites in any form, either regularly or intermittently is contraindicated. Drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form.</strong></p>
<p>The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.</p>
<p>Sildenafil is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors (e.g., patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris) (see PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The possibility of undiagnosed cardiovascular disorders in men with erectile dysfunction should be considered before prescribing sildenafil.</p>
<p>Sildenafil is not recommended in patients with male erectile dysfunction with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see PRECAUTIONS and ADVERSE EFFECTS, Post Marketing Experience – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), hypertension (blood pressure >170/110 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 PDEs).</p>
- Atc Code
- G04BE03
- Atc Item Name
- sildenafil
- Pharma Manufacturer Name
- IX BIOPHARMA LTD.
- Company Detail Path
- /organization/ix-biopharma-ltd
