Regulatory Information
VIATRIS PRIVATE LIMITED
VIATRIS PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Sildenafil tablets are for oral administration. **Use in adults** _Film-coated tablets_ 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 100 mg or decreased to 25 mg. The maximum recommended daily dose is 100 mg. The maximum recommended dosing frequency is once per day. _Orodispersible tablets_ The recommended dose is 50 mg taken on an empty stomach as needed approximately one hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to 100 mg film-coated or decreased to 25 mg film-coated tablets. The maximum recommended dose is 100 mg. For patients requiring a dose increase to 100 mg and wanting to take the orodispersible tablets, two 50 mg orodispersible tablets should be administered sequentially. The maximum recommended dosing frequency is once per day. There is a significant delay in absorption when the orodispersible tablet is taken with a high fat meal compared to the fasted state (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The orodispersible tablets can be taken with or without water. **Use in patients with impaired renal function** Dosage adjustments are not required in 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. **Use in patients with impaired hepatic function** Since sildenafil clearance is reduced in patients with hepatic impairment (e.g., cirrhosis), a 25 mg dose should be considered. **Use in patients using other medications** Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), 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. 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 section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. 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 sections 4.4 and section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in children** Sildenafil is not indicated for use in children (<18 years old). **Use in elderly men** Since sildenafil clearance is reduced in elderly patients, a first dose of 25 mg should be considered. **Method of administration** _Orodispersible tablets_ The orodispersible tablet should be placed in the mouth, on the tongue, where it will rapidly disintegrate, and then be swallowed. The orodispersible tablets can be taken with or without water and should be taken immediately upon removal from the blister. For patients requiring a second 50 mg orodispersible tablet to make a 100 mg dose, the second tablet should be taken upon full disintegration of the first tablet. It is recommended that the orodispersible tablets be taken on an empty stomach.
ORAL
Medical Information
**4.1 Therapeutic indications** 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.
**4.3 Contraindications** 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 section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. 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), 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). 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). Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure.
G04BE03
sildenafil
Manufacturer Information
VIATRIS PRIVATE LIMITED
Fareva Amboise