ROCLA 100
ROCLA 100
Active ingredient: Sildenafil 100 mg
Dosage form: Film-coated tablet.
Packaging: Box of 1 blister x 1 tablet or 4 tablets.
Expiry date: 36 months.
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 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day.
Renal impairment
Dose 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.
Hepatic impairment
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis), a 25 mg dose should be considered.
Use in patients taking other medicinal products
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 48-hour period.
A starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (e.g., erythromycin, saquinavir, ketoconazole, itraconazole) (see INTERACTIONS).
In order to minimize the potential of 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 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and INTERACTIONS).
Paediatric population
Sildenafil is not indicated for use in children below 18 years of age.
Elderly
Dosage adjustments are not required.
INDICATIONS
Sildenafil is indicated for 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.
CONTRAINDICATIONS
Sildenafil is contraindicated in patients with 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).
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.
