Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

revatio_product

Indication¹

Treatment of pulmonary arterial hypertension classified as World Health Organization (WHO) functional class III to improve exercise capacity.

Clinical Evidence

Improves exercise capacity, WHO functional class and haemodynamics in patients with symptomatic pulmonary arterial hypertension²

Safety Profile¹

CI:	Known hypersensitivity to any component of the tablet. Sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.

SP:	Patient at risk of non-arteritic anterior ischaemic optic neuropathy (NAION); known hereditary degenerative retinal disorders, eg, retinitis pigmentosa; hypotension; fluid depletion; severe left ventricular outflow obstruction or autonomic dysfunction; anatomical deformation of the penis; with conditions which may predispose patients to priapism; bleeding disorders or active peptic ulceration. Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Children and adolescents <18 years.

AR:	Very common/common Headache, flushing, dyspepsia, back pain, diarrhoea, limb pain, myalgia, cough, epistaxis, insomnia, pyrexia.

DI:	β-blockers, ketoconazole, itraconazole, ritonavir, bosentan, carbamazepine, phenytoin, phenobarbital, St John's wort, rifampicin, cimetidine, grapefruit juice, nicorandil, α-blockers, eg, doxazosin, nitric oxide donors or nitrates in any form.

Dosages¹

Adults ≥18 years 20 mg three times daily. Renal (creatinine clearance <30 mL/min)/hepatic impairment Downward dose adjustment to 20 mg twice daily.

Strengths¹

20 mg.

Packing¹

20 mg x 90’s.

References

1. Revatio full prescribing information. Hong Kong. November 2007.
2. Galiè N, et al. N Engl J Med 2005;353:2148-2157.

Please review the full product information or package insert before prescribing.