Cylos

Cylos

cilostazol

Manufacturer:

Paradigm Pharma

Distributor:

Littman
Concise Prescribing Info
Contents
Cilostazol
Indications/Uses
Improvement of maximal & pain-free walking distances in patients w/ intermittent claudication who do not have rest pain & evidence of peripheral tissue necrosis. 2nd-line use in patients for whom lifestyle modifications (including stopping smoking & supervised exercise programs) & other appropriate interventions have failed to sufficiently improve their intermittent claudication symptoms.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 30 min before or 2 hr after meals.
Contraindications
Hypersensitivity. CHF of any grade or severity. Patients w/ known predisposition to bleeding [eg, active peptic ulceration, recent (w/in six months) haemorrhagic stroke, surgery w/in the previous 3 mth, proliferative diabetic retinopathy, poorly controlled HTN) or any active or uncontrolled bleeding; history of ventricular tachycardia or fibrillation or multifocal ventricular ectopic beats, whether or not adequately treated; history of severe tachyarrhythmia; unstable angina pectoris, or MI or coronary intervention w/in the last 6 mth. Concomitant use w/ CYP3A4 or CYP2C19 inhibitors eg, cimetidine, diltiazem, erythromycin, ketoconazole, lansoprazole, omeprazole & HIV-1 PIs; ≥2 additional antiplatelet or anticoagulant agents eg, ASA, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban. Severe renal impairment (CrCl <25 mL/min). Moderate or severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Discontinue use in case of retinal bleeding; clinical or laboratory evidence of haematological abnormalities. May induce tachycardia, palpitation, tachyarrhythmia &/or hypotension. Patients w/ atrial or ventricular ectopy & atrial fibrillation or flutter. Episode of bleeding or easy bruising during therapy; any other signs suggesting early development of blood dyscrasia eg, pyrexia & sore throat. Stop treatment 5 days prior to surgery if patient is to undergo elective surgery & antiplatelet effect is not necessary. Reassess patient after 3 mth of treatment w/ a view to discontinue Cylos where inadequate effect is observed or symptoms have not improved. Closely monitor patients who may be at increased risk for serious cardiac adverse events as a result of increased heart rate eg, patients w/ stable coronary disease during treatment. Concomitant use w/ any other agent w/ potential to reduce BP; any other agents inhibiting platelet aggregation. May cause dizziness which may affect ability to drive & use machines.
Adverse Reactions
Diarrhoea, abnormal stools. Ecchymosis; oedema (peripheral, face); dizziness; palpitation, tachycardia, angina pectoris, arrhythmia, ventricular extrasystoles; rhinitis, pharyngitis; nausea & vomiting, dyspepsia, flatulence; rash, pruritus; chest pain, asthenia.
Drug Interactions
Increased inhibition of ADP-induced ex vivo platelet aggregation w/ aspirin. Increased AUC of dehydro metabolite w/ clopidogrel. Higher rate of haemorrhage w/ clopidogrel & aspirin. Increased total pharmacological activity & potentially enhanced undesirable effects w/ CYP3A4 (eg, some macrolides, azole antifungals, PIs) & CYP2C19 (eg, PPIs) inhibitors. Increased overall pharmacologic activity w/ erythromycin, ketoconazole, diltiazem, omeprazole. Possible interaction w/ high quantities of grapefruit juice. Increased AUC of lovastatin. Co-administration w/ CYP3A4 substrates w/ narrow therapeutic index (eg, cisapride, halofantrine, pimozide, ergot derivatives); statins metabolized by CYP3A4 (eg, simvastatin, atorvastatin & lovastatin). Antiplatelet effect may be altered w/ CYP3A4 & CYP2C19 inducers. Decreased plasma conc w/ smoking. Possible additive hypotensive effect w/ a reflex tachycardia w/ any other agent which has the potential to reduce BP.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC23 - cilostazol ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Cylos tab 100 mg
Packing/Price
100's
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