General MedicationsORALHigh Alert

Sildenafil

SILDENAFIL

Standard Dose

2 DOSAGE & ADMINISTRATION For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 ) 2.1 Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. 2.2 Use with Food Sildenafil tablets may be taken with or without food. 2.3 Dosage Adjustments in Specific Situations Sildenafil tablets were shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see Contraindications ( 4.1 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 )]. When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil tablets should be initiated at 25 mg [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.2 )]. 2.4 Dosage Adjustments Due to Drug Interactions Ritonavir The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.4 ), and Clinical Pharmacology ( 12.3 )]. CYP3A4 Inhibitors Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 )]. 2.5 Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets [see Use in Specific Populations ( 8.5 , 8.6 , 8.7 ) and Clinical Pharmacology ( 12.3 )].

Max Dose

See official label

Primary Use

1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction.

Summary

Indications and usage 1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction.

Sildenafil tablets are phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 ) Dosage and administration 2 DOSAGE & ADMINISTRATION For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets are phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 ) Dosage and administration 2 DOSAGE & ADMINISTRATION For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 ) 2.1 Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. 2.2 Use with Food Sildenafil tablets may be taken with or without food. 2.3 Dosage Adjustments in Specific Situations Sildenafil tablets were shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see Contraindications ( 4.1 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 )]. When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil tablets should be initiated at 25 mg [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.2 )]. 2.4 Dosage Adjustments Due to Drug Interactions Ritonavir The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.4 ), and Clinical Pharmacology ( 12.3 )]. CYP3A4 Inhibitors Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 )]. 2.5 Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance 4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2 ) Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. ( 5.3 ) Patients should stop sildenafil and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4 ) Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5 ) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil dosage is recommended ( 2.4 , 5.6 ) 5.1 Cardiovascular There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology ( 12.2 )] . While this normally would be ex

Monitoring

• 5 WARNINGS AND PRECAUTIONS Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) Patients should seek emergency treatment if an erection lasts >4 hours.
• Use sildenafil with caution in patients predisposed to priapism ( 5.2 ) Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).
• Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
• Patients with a “crowded” optic disc may also be at an increased risk of NAION.

Interaction Notes

• 7 DRUG INTERACTIONS Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose ( 2.3 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 ) 7.1 Nitrates Administration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated.
• Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration ( 2.3 ), Contraindications ( 4.1 ), Clinical Pharmacology ( 12.2 )].
• 7.2 Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressurelowering effects.
• When sildenafil is co-administered with an alpha-blocker, patients should be stable on alphablocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [see Dosage and Administration ( 2.3 ),Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 )].