Revatio

Revatio

sildenafil

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Adult patients w/ pulmonary arterial HTN (WHO functional class II & III) to improve exercise capacity. Efficacy has been shown in primary pulmonary HTN & pulmonary HTN associated w/ connective tissue disease.
Dosage/Direction for Use
Recommended dose: 20 mg 3 times daily. Patient receiving CYP3A4 inhibitors eg, erythromycin 20 mg twice daily. Patient receiving CYP3A2 inhibitors eg, clarithromycin 20 mg once daily. Patient w/ renal & hepatic impairment 20 mg twice daily only if therapy is not well-tolerated.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ nitric oxide donors (eg, amyl nitrate) or nitrates; PDE-5 inhibitors w/ guanylate cyclase stimulators (eg, riociguat); most potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Loss of vision in 1 eye due to non-arteritic anterior ischaemic optic neuropathy. Recent history of stroke or MI. Severe hypotension (BP <90/50 mmHg) at initiation. Severe hepatic impairment.
Special Precautions
Patients w/ hypotension, fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction; veno-occlusive disease; bleeding disorders or active peptic ulceration; anatomical deformation of the penis eg, angulation, cavernosal fibrosis or Peyronie's disease; sickle cell anaemia, multiple myeloma or leukaemia. Prolonged erection (lasting >4 hr) & priapism. Serious CV events including MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, HTN & hypotension. Discontinue treatment immediately in the event of any sudden visual defect/loss. Co-administration w/ α-blockers; bosentan; vit K antagonists; other PDE-5 inhibitors. Not recommended in patients w/ hereditary degenerative retinal disorders eg, retinitis pigmentosa. Patients w/ severe pulmonary arterial HTN (functional class IV); WHO functional class I pulmonary arterial HTN. Not recommended in other forms of pulmonary arterial HTN. Not to be used in patients w/ pulmonary HTN secondary to sickle cell anaemia. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive & use machines. Not recommended for women of childbearing potential. Not to be used in pregnant women. Lactation.
Adverse Reactions
Influenza; insomnia; headache; visual disturbance/impairment, blurred vision; flushing; epistaxis, cough; nasal congestion; diarrhoea, dyspepsia; myalgia, back pain, pain in extremity; pyrexia. Cellulitis, bronchitis, sinusitis, rhinitis, gastroenteritis; anaemia; fluid retention; anxiety; migraine, tremor, paraesthesia, burning sensation, hypoaesthesia; retinal haemorrhage, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia; vertigo; gastritis, GERD, haemorrhoids, abdominal distension, dry mouth; alopecia, erythema, night sweats.
Drug Interactions
CYP3A4 (major route) & 2C9 (minor route) inhibitors may reduce sildenafil clearance & inducers may increase sildenafil clearance. Decreased exposure w/ CYP3A4 inducers eg, bosentan, carbamazepine, phenytoin, phenobarb, St. John's wort, rifampicin. Increased AUC w/ CYP3A4 inhibitors eg, saquinavir, erythromycin, clarithromycin, telithromycin, nefazodone. Increased exposure w/ β-blockers. Concomitant use w/ grapefruit juice is not recommended. Potential serious interaction w/ nicorandil. Potentiate the hypotensive effects of nitrates. May lead to symptomatic hypotension w/ α-blockers. Increased AUC of bosentan. Additive systemic BP lowering effect w/ riociguat. Co-administration w/ other treatments for pulmonary arterial HTN (eg, ambrisentan, iloprost). Increased oral bioavailability w/ CYP3A4 substrates.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX - Antihypertensives for pulmonary arterial hypertension ; Used in the treatment of pulmonary arterial hypertension.
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Revatio FC tab 20 mg
Packing/Price
6 × 15's (Rp10,285,411/boks)
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