Regulatory Information
ACCORD HEALTHCARE PRIVATE LIMITED
ACCORD HEALTHCARE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**v. Dosage and 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. **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, 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). 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. **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.
ORAL
Medical Information
**iv. Therapeutic Indication:** 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.
**vii. 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. 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
ACCORD HEALTHCARE PRIVATE LIMITED
INTAS PHARMACEUTICALS LIMITED
Active Ingredients
Documents
Package Inserts
Intagra Tablet PI.pdf
Approved: May 12, 2023