Revatio

Revatio

sildenafil

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Class II & III pulmonary arterial HTN 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.
Administration
May be taken with or without food.
Contraindications
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. 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, patients w/ 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. Pulmonary arterial HTN class I & IV; non-arteritic anterior ischaemic optic neuropathy; hypotension, fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction; bleeding disorders or active peptic ulceration; pulmonary HTN associated w/ pulmonary veno-occlusive disease; hearing impairment. Serious CV events in male erectile dysfunction eg, MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, HTN & hypotension. Concomitant use w/ α-blockers, vit K antagonist, bosentan & other PDE-5 inhibitors. Galactose intolerance, Lapp 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. 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. Caution w/ other treatment for pulmonary arterial HTN eg, ambrisentan, iloprost. Reduced clearance &/or increased oral bioavailability w/ CYP3A4 substrates & combinations w/ β-blockers. Decreased exposure w/ bosentan. Closely monitor efficacy w/ potent CYP3A4 inducers eg, carbamazepine, phenytoin, phenobarb, St. John's wort, rifampicin. Contraindicated w/ ritonavir in pulmonary arterial HTN patients. Increased systemic exposure w/ erythromycin. Modest increased plasma levels w/ grapefruit juice. Potential serious interaction w/ nicorandil. Increased bosentan AUC at steady state. Symptomatic hypotension w/ α-blocker. Potentiated hypotensive effects of nitrates. Additive systemic BP-lowering effect w/ riociguat.
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.
Presentation/Packing
Form
Revatio FC tab 20 mg
Packing/Price
90's
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