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Sildenafil

    Brands

    DEA Class; Rx

    Common Brand Names; Revatio, Viagra

    • PAH, PDE-5 Inhibitors; 
    • Phosphodiesterase-5 Enzyme Inhibitors

    Oral, selective phosphodiesterase type 5 (PDE5) inhibitor
    Used for pulmonary arterial hypertension (PAH) and erectile dysfunction (ED)
    As with other PDE5 inhibitors, contraindicated for use with nitrates because the combination can cause a sudden drop in blood pressure

    Indicated For the treatment of erectile dysfunction (ED).

    For the treatment of pulmonary hypertension.
    For the treatment of Raynaud’s phenomenon resistant to vasodilator therapy.
    For altitude sickness prophylaxis, specifically prevention of high altitude pulmonary edema.
    For the treatment of persistent pulmonary hypertension of the newborn (PPHN).

    Hypersensitivity

    Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

    >10%

    Viagra

    • 25-mg dose
      • Headache (16%)
    • 50-mg dose
      • Headache (21%)
      • Flushing (19%)
      • 100-mg dose H5
      • Headache (28%)
      • Flushing (18%)
      • Dyspepsia (17%)
      • Abnormal vision (11%)
    • Revatio
      • Headache (46%)
      • Dyspepsia (13%)

    1-10%

    Viagra

    • 25-mg dose
      • Flushing (10%)
      • Nasal congestion (4%)
      • Dyspepsia (3%)
      • Back pain (3%)
      • Dizziness (3%)
      • Myalgia (2%)
      • Nausea (2%)
      • Abnormal vision (1%)
      • Rash (1%)
    • 50-mg dose
      • Dyspepsia (9%)
      • Nasal congestion (4%)
      • Back pain (4%)
      • Dizziness (4%)
      • Nausea (3%)
      • Abnormal vision (2%)
      • Myalgia (2%)
      • Rash (2%)
    • 100-mg dose
      • Nasal congestion (9%)
      • Back pain (4%)
      • Myalgia (4%)
      • Nausea (3%)
      • Dizziness (3%)
      • Rash (3%)

    Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure

    Use with caution in patients with anatomic deformation of penis (eg, angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors

    Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease

    Patient taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initated at lowest dose to avoid hypotension

    Not to be taken with other PDE-5 inhibitors

    Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness

    Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION); use 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; advise patients to seek immediate medical attention in the event of a sudden loss of vision

    Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status

    Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death

    Limited published data from a case report describe presence of sildenafil and its active metabolite in human milk

    Adults

    100 mg/day PO for erectile dysfunction; 60 mg/day PO or 30 mg/day IV for pulmonary arterial hypertension. Doses up to 240 mg/day PO were utilized during clinical trials for pulmonary arterial hypertension; however, no greater efficacy was observed and the manufacturer recommends not to exceed 60 mg/day.

    Geriatric

    100 mg/day PO for erectile dysfunction; 60 mg/day PO or 30 mg/day IV for pulmonary arterial hypertension. Doses up to 240 mg/day PO were utilized during clinical trials for pulmonary arterial hypertension; however, no greater efficacy was observed and the manufacturer recommends not to exceed 60 mg/day.

    Adolescents

    Safety and efficacy have not been established. Guidelines recommend 20 mg PO 3 times daily.

    Children

    Weight more than 20 kg: Safety and efficacy have not been established. Guidelines recommend 20 mg PO 3 times daily.
    Weight 20 kg or less: Safety and efficacy have not been established. Guidelines recommend 10 mg PO 3 times daily.

    Infants

    Safety and efficacy have not been established. Guidelines recommend 1 mg/kg/dose PO every 8 hours.

    Neonates

    Safety and efficacy have not been established. Guidelines recommend 1 mg/kg/dose PO every 8 hours and 0.4 mg/kg IV as a loading dose followed by a continuous infusion of 0.067 mg/kg/hour.

    Sildenafil citrate

    tablet (Revatio)

    • 20mg

    tablet (Viagra)

    • 25mg
    • 50mg
    • 100mg

    injectable solution (Revatio)

    • 10mg/12.5mL

    oral suspension (Revatio)

    • 10mg/mL (when reconstituted)