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PLETAAL

CILOSTAZOL · by OTSUKA

PERIPHERAL VASODILATORS Antiplatelet-vasodilator OTSUKA

Composition

Tab 50 mg/100 mg: Cilostazol 50 mg/100 mg.

Indications & Dosage

Intermittent claudication in patients without rest pain and no peripheral tissue necrosis: Adult: 100 mg twice daily, to be taken 30 min before food. Reduce dose to 50 mg twice daily with concomitant use of potent inhibitors of cytochrome P450 enzymes CYP3A4 or CYP2C19, or with erythromycin or omeprazole. Children: Not recommended.

Contraindications

Active peptic ulcer, congestive heart failure, coronary intervention or haemorrhagic stroke or myocardial infarction in previous 6 month, history of severe tachyarrhythmia, hypertension, predisposition to bleeding, proliferative diabetic retinopathy, prolongation of QT interval, severe atrial flutter, unstableangina, severe renal or hepatic impairment, congestive heart failure.

Precautions

Patients should be assessed for improvement after 3 months; discontinue treatment if there is no improvement in walking distance. Advise patients to report any episodes of bleeding or bruising. Caution in case of Atrial or ventricular ectopy, atrial fibrillation or flutter, stable coronary disease, surgery and diabetes.

Interactions

Cimetidine, diltiazem, erythromycin, ketoconazole, lansoprazole, omeprazole, protease inhibitors, cisap-ride, midazolam, nifedipine, verapamil, other inhibitors or substrates of CYP3A4 or 2C19. Highly protein bound drugs, hypotensive agents, aspirin, antiplatelets, clopidogrel, anticoagulants, vasodilators

Pregnancy

Contraindicated in pregnancy.

Lactation

Not recommended.

Side Effects

Headache, ventricular extrasystole, rhinitis, angina, anorexia, arrhythmia, diarrhoea, dizziness, dyspepsia, ecchymosis, flatulence, malaise, nausea, oedema, palpitation, pharyngitis, pruritus, rash, tachycardia, vomiting