Zuellig Pharma
Concise Prescribing Info
Sildenafil citrate
Pulmonary arterial HTN functional class II & III in adult patients. Primary pulmonary & pulmonary HTN associated w/ connective tissue disease.
Dosage/Direction for Use
Adult ≥18 yr 20 mg tds taken approx 6-8 hr apart. Patient receiving CYP3A4 inhibitors 20 mg bd. Patient receiving CYP3A2 inhibitors 20 mg once daily. Renal & hepatic impairment 20 mg bd only if therapy is not well tolerated.
May be taken with or without food.
Hypersensitivity. Recent history of stroke or MI, severe hypotension (BP <90/50 mmHg) at initiation; loss of vision in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). Co-administration w/ nitric oxide donors (eg, amyl nitrite) or nitrates; guanylate cyclase stimulators eg, riociguat. Combination w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Severe hepatic impairment.
Special Precautions
Discontinue use if any sudden visual defects occur. Not recommended in other forms of pulmonary arterial HTN; known hereditary degenerative retinal disorders eg, retinitis pigmentosa. Not to be used in patients w/ pulmonary HTN secondary to sickle cell anaemia. Anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism eg, sickle cell anaemia, multiple myeloma or leukemia. Serious CV events eg, MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, HTN, hypotension. Pulmonary arterial HTN functional class I & IV; hypotension, fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction; NAION; bleeding disorders or active peptic ulceration; pulmonary HTN associated w/ pulmonary veno-occlusive disease; hearing impairment. Avoid abrupt discontinuation. Concomitant use w/ α-blockers, vit K antagonist, bosentan, other PDE-5 inhibitors. Not to be used in galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in women of childbearing potential. Not to be used during pregnancy. Lactation. Not recommended in childn <18 yr.
Adverse Reactions
Headache; flushing; diarrhoea, dyspepsia; pain in extremity. Cellulitis, flu, bronchitis, sinusitis, rhinitis, gastroenteritis; anaemia; fluid retention; insomnia, anxiety; migraine, tremor, paresthesia, burning sensation, hypoaesthesia; retinal haemorrhage, visual impairment, blurred vision, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia; vertigo; epistaxis, cough, nasal congestion; gastritis, GERD, haemorrhoids, abdominal distension, dry mouth; alopecia, erythema, night sweats; myalgia, back pain; pyrexia.
Drug Interactions
Reduced clearance w/ CYP3A4 inhibitors. Increased clearance w/ CYP3A4 inducers. Reduced clearance &/or increased oral bioavailability w/ CYP3A4 substrates & β-blockers. Decreased exposure w/ bosentan. Increased Cmax & plasma AUC w/ HIV PIs eg, ritonavir, saquinavir. Increased systemic exposure w/ erythromycin, CYP3A4 inhibitors & substrates. Increased plasma conc w/ cimetidine. Modest increased plasma levels w/ grapefruit juice. Potential serious interaction w/ nicorandil. Increased bosentan AUC. Reduced supine systolic & diastolic BP w/ amlodipine. Symptomatic hypotension w/ α-blocker. Potentiated hypotensive effects of nitrates. Additive systemic BP-lowering effect w/ riociguat. Concomitant use w/ other treatment for pulmonary arterial HTN eg, ambrisentan, iloprost; other PDE-5 inhibitors; potent CYP3A4 inducers eg, carbamazepine, phenytoin, phenobarb, St. John's wort, rifampicin.
MIMS Class
Other Antihypertensives
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
C02KX - Antihypertensives for pulmonary arterial hypertension ; Used in the treatment of pulmonary arterial hypertension.
Revatio FC tab 20 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in