Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Consult your doctor or pharmacist for more details. Read the Patient Information Leaflet provided by your pharmacist before you start taking sildenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. To treat erectile dysfunction-ED, take this drug by mouth as directed by your doctor, usually as needed. Take sildenafil at least 30 minutes, but no more than 4 hours, before sexual activity (1 hour before is the most effective). 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Revatio PO: 5 mg or 20 mg 3 times daily, administered 4-6 hours apart IV: 2.5-mg or 10-mg bolus 3 times daily if patient is temporarily unable to take PO Recommended PO/IV dose not to be exceeded Adding Revatio to bosentan does not have any beneficial effect on exercise capacity Not to be prescribed to children (1-17 years) for pulmonary arterial hypertension (PAH); this recommendation against use is based on long-term clinical pediatric trial showing that children taking high doses had higher risk of death than children taking low doses and that low doses were not effective in improving exercise ability (see Cautions) 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 May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (eg, scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%) Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy; there are risks to mother and fetus from untreated pulmonary arterial hypertension 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; there is insufficient information about effects of sildenafil on breastfed infant and no information on effects of sildenafil on milk production; limited clinical data during lactation preclude a clear determination of risk of drug to an infant during lactation The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. Initial dose: 50 mg orally once a day, as needed, 1 hour prior to sexual activity Maintenance: 25 to 100 mg orally once a day, as needed, 1 hour prior to sexual activity Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity. Use: Treatment of erectile dysfunction Revatio (R): Oral: -Initial dose: 5 or 20 mg orally three times a day, 4 to 6 hours apart -Maximum dose: 20 mg orally three times a day Injection: -Initial dose: 2.5 or 10 mg IV bolus three times a day Comments: -No greater efficacy was achieved with oral doses higher than the maximum recommended dose. -A 10 mg injection dose is predicted to provide pharmacological effect equivalent to the 20 mg oral dose. Use: Treatment of PAH (WHO Group I) in adults to improve exercise ability and delay clinical worsening Initial dose: 25 mg orally once a day 1 hour prior to sexual activity Use: Treatment of erectile dysfunction Erectile dysfunction: -Mild to moderate renal dysfunction (Cr Cl 30 to less than 80 m L/min): No adjustment recommended. -Severe renal dysfunction (Cr Cl less than 30 m L/min): 25 mg orally once a day 1 hour prior to sexual activity Pulmonary Arterial Hypertension: Revatio (R): -No adjustment recommended. Erectile dysfunction: -Initial dose: 25 mg orally should be considered in patients with any degree of hepatic impairment Pulmonary Arterial Hypertension: Revatio (R): -Mild to moderate hepatic dysfunction (Child-Pugh Class A and B): No adjustment recommended. -Severe hepatic dysfunction (Child-Pugh Class C): Has not been studied Concomitant administration with alpha blockers: -Initial dose: 25 mg orally 1 hour prior to sexual activity -Patients should be stable on alpha blocker therapy prior initiating treatment with this drug. 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