Sildenafil

Clinical summary

Indications and usage 1. INDICATION S AND USAGE SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction. SILDENAFIL ORAL FILM is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). ( 1 ) Dosage and administration 2. DOSAGE AND ADMINISTRATION Dosage For most patients, the recommended dosage is 50 mg orally, taken as needed, approximately 1 hour before sexual activity. However, SILDENAFIL ORAL FILM may be taken anywhere from 30 minutes to 4 hours before sexual activity. ( 2.1 ) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg. ( 2.1 ) Maximum recommended dosing frequency is once per day. ( 2.1 ) Dosage Modifications for Drug Interactions: Refer to the full prescribing information for recommended dosage. ( 2.2 ) Recommended Dosage in Specific Populations: Refer to the full prescribing information for recommended dosage. ( 2.3 ) Administration Administer with or without food. Place oral film directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Do not cut or chew SILDENAFIL ORAL FILM. 2.1 Recommended Dosage For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. However, SILDENAFIL ORAL FILM may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Based on effectiveness and tolerability the dosage may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, not to exceed once per day. For administration instructions, see Dosage and Administration ( 2.4 ) . 2.2 Dosage Modifications for Drug Interactions Nitrates Concomitant use of nitrates in any form is contraindicated [ see Contraindications ( 4.1 ), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 ) ]. Alpha Blockers Initiate SILDENAFIL ORAL FILM at 25 mg orally in patients on concomitant therapy with an alpha-blocker. Patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.2 ) ] . For administration instructions, see Dosage and Administration ( 2.4 ) . Ritonavir The maximum recommended dose and dosing frequency is 25 mg orally taken once within a 48-hour period in ritonavir-treated patients. Concomitant administration of ritonavir increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.4 ), and Clinical Pharmacology ( 12.3 ) ] . For administration instructions, see Dosage and Administration ( 2.4 ) . Other CYP3A4 Inhibitors The recommended starting dosage is 25 mg orally, in patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased blood levels of sildenafil by about 3-fold [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 ) ] . For administration instructions, see Dosage and Administration ( 2.4 ) . 2.3 Recommended Dosage in Specific Populations Age G reater than 6 5 years The recommended starting dosage is 25 mg orally in patients greater than 65 years of age [see Use in Specific Populations ( 8.5 ) ]. For administration instructions, see Dosage and Administration ( 2.4 ) . Renal Impairment The recommended starting dosage is 25 mg orally, in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). The recommended starting dosage is 50 mg, in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 49 mL/min) renal impairment [see Use in Specific Populations( 8.6 ) and Clinical Pharmacology ( 12.3 ) ]. For administration instructions, see Dosage and Administration ( 2.4 ) . Hepatic Impairment The recommended starting dosage is 25 mg orally in patients with any degree of hepatic impairment. In volunteers with mild and moderate degrees of hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for Cmax and 85% for AUC), and the pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh Class C) have not been studied [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 ) ]. For administration instructions, see Dosage and Administration ( 2.4 ) . 2.4 Important Administration Instructions Administer SILDENAFIL ORAL FILM orally with or without food. Place the oral film directly onto the tongue, where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Do not cut or chew SILDENAFIL ORAL FILM. Warnings and cautions 5. WARNINGS AND PRECAUTIONS Patients should not use SILDENAFIL ORAL FILM if sexual ac