IntroducIng rEVAtIo
®
A wEll EstAblIshEd PdE-5 InhIbItor rEgIstErEd
for usE In PulmonAry ArtErIAl hyPErtEnsIon (PAh)
REVATIO
®
helping your patients to do more...
•
Significantly improves exercise capacity (p<0.001)
(1)
•
Significantly reduces mean pulmonary arterial pressure (p=0.04)
(1)
•
Significantly improves physical functioning and general health (p<0.001)
(2)
...without holding them back
•
Convenient oral dosing: 20 mg tds with or without meals
•
Adverse events are generally transient and mild to moderate
(1,3)
•
Low discontinuation rate comparable to placebo
•
No monthly liver function testing required
(3)
References: 1.
Galiè N, Ghofrani HA,Torbicki A, Barst RJ, Rubin LJ, Badesch D,
et al
. Sildenafil Citrate Therapy for Pulmonary Arterial Hypertension.
N Engl J Med
2005;
353
(20):2148-2157.
2.
Pepke-Zaba J, Gilbert C, Collings L, Brown MCJ. Sildenafil Improves Health-Related Quality of Life in
Patients With Pulmonary Arterial Hypertension.
Chest
2008;
133
:183-189.
3.
Croom KF, Curran MP. Sildenafil.A Review of its Use in Pulmonary Arterial Hypertension.
Drugs
2008;
68
(3):338-397.
S4 REVATIO
®
Film-coated tablets (Reg. No.A40/7.1.5/0131). COMPOSITION: Each tablet contains 20 mg of sildenafil, as the citrate. PHARMACOLOGICAL CLASSIFICATION:A 7.1.5 Vasodilators – peripheral. INDICATIONS:Treatment of pulmonary arterial hypertension. REVATIO has been shown to
improve exercise ability and to reduce mean pulmonary arterial pressure. CONTRA-INDICATIONS: Known hypersensitivity to any component of the tablet. Patients concurrently using nitric oxide donors or organic nitrates in any form. Concomitant use with ritonavir,erythromycin,saquinavir,ketoconazole
and itraconazole. Severe hepatic or renal function. Pregnancy and Lactation. WARNINGS: No controlled clinical data in MI, stroke, or life-threatening arrhythmia within the last 6 months; resting hypotension (BP <90/50) or hypertension (BP >170/110); cardiac failure or CAD causing unstable
angina and retinitis pigmentosa. Physicians should carefully consider whether patients with underlying CVD could be affected adversely by transient decreases in supine BP, especially in combination with sexual activity. Serious events, including MI, sudden cardiac death, ventricular dysrhythmia,
cerebrovascular haemorrhage, transient ischaemic attack,and hypertension have been reported.Most patients had pre-existing CV risk factors.Use with caution in patients with anatomical deformation of the penis,or conditions which may predispose to priapism. Patients taking alpha-blocker therapy
may lead to symptomatic hypotension. Administer with caution to patients with bleeding disorders or active peptic ulceration.Decreased vision or loss of vision,has been reported.Exercise caution before driving,operating hazardous machinery or performing hazardous tasks. DOSAGEAND DIRECTIONS
FOR USE: 20 mg three times a day approximately 6 to 8 hours apart with or without food. Dose adjustments may be required when co-administered with bosentan or other CYP3A4 inducers. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Most commonly reported side-effects included headache,
flushing, dyspepsia, back pain, diarrhoea and limb pain. Other common side-effects include cellulitis, influenza, sinusitis, anaemia, fluid retention, insomnia, anxiety, migraine, tremor, paraesthesia, burning sensation, hypoaesthesia, visual acuity reduced, retinal haemorrhage, visual disturbance,
photophobia, diploplia, chromatopsia, cyanopsia, abnormal sensation in eye, eye irritation, vertigo, bronchitis, epistaxis, rhinitis, cough, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, abdominal distension, alopecia, erythema, myalgia, gynaecomastia, pyrexia and weight
increase. A sudden unilateral or bilateral decrease or loss of hearing (sensorinearal deafness) with or without associated vestibular symptoms has been reported. LICENCE HOLDER: Pfizer Laboratories (Pty) Ltd. Reg. No.: 1954/000781/07. P.O. Box 783720, Sandton 2146. Tel. No.: 0860 PFIZER
(734937). PI Ref: 13/07/09. Please refer to the detailed package insert for full prescribing information. 01/01/REV/10/JA
