Revatio^®

Abbreviated Prescribing Information¹

Presentation: Revatio^® (Sildenafil Citrate) 20 mg film-coated tablet is available in blister tab of 90’s. Indication: Revatio^® (Sildenafil Citrate) is indicated for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional Class II and Class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Dosing: The recommended dose is 20 mg three times a day. Tablets should be taken approximately 6–8 hours apart with or without food. Patients who forget to take Revatio^® should take a dose soonest possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose. A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors. A gradual dose reduction should be considered in all patients. Dose adjustments are not required in elderly patients. Initial dose adjustments are not required in patients with renal impairment (including severe renal impairment with creatinine clearance <30 ml/min) and hepatic impairment (Child-Pugh class A and B). A downward dose adjustment to 20 mg twice daily should be considered in hepatic impairment patients after a careful benefit-risk assessment only if therapy is not well-tolerated. Not recommended for use in children below 18 years. Contraindications: Hypersensitivity to any component of this medication, co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form, co-administration with guanylate cyclase stimulators such as riociguat, combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir), patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure, severe hepatic impairment, recent history of stroke or myocardial infarction, severe hypotension (blood pressure <90/50 mmHg) at initiation. Special precautions: Mortality with paediatric use, retinitis pigmentosa, vasodilatory action, cardiovascular risk factors, visual events, penile deformity or conditions predisposing to priapism, vaso-occlusive crises in patients with sickle cell anaemia, concomitant use with alpha-blockers, concomitant use with vitamin K antagonist, bleeding disorders or active peptic ulcer, veno-occlusive disease, galactose intolerance, total lactase deficiency or glucose–galactose malabsorption, risk factors for hearing impairment, use of sildenafil with bosentan and other PDE5 inhibitors, patient treated with sacubitril/valsartan. Adverse reactions: Headache, flushing, diarrhoea, dyspepsia, pain in the extremity, cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis, anaemia, fluid retention, insomnia, anxiety, migraine, tremor, paresthesia, burning sensation, hypoaesthesia, retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia, vertigo, epistaxis, cough, nasal congestion, gastritis, gastro-oesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth, alopecia, erythema, night sweats, myalgia, back pain, pyrexia.

API-REVATIO-0622

Reference: 1. Malaysia Revatio^® Prescribing Information dated 23 June 2022.