Trombocil Special Precautions





Full Prescribing Info
Special Precautions
Cardiovascular Effects: Cilostazol may induce tachycardia, palpitation, tachyarrhythmia and/or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction.
Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after initiating cilostazol.
Hematologic Adverse Reactions: There have been case reports of thrombocytopenia or leukopenia progressing to agranulocytosis when cilostazol was not immediately discontinued. Agranulocytosis was reversible on discontinuation of cilostazol. Periodically monitor platelet and white blood cell counts.
Cilostazol inhibits platelet aggregation in a reversible manner. Cilostazol has not been studied in patients with hemostatic disorders or active pathologic bleeding. Avoid use of cilostazol in these patients.
Patients should report any episode of bleeding or easy bruising during therapy. Discontinue cilostazol in cases of retinal bleeding.
The risk of intraocular bleeding may be higher in patients with diabetes.
Patients should promptly report any other signs which might also suggest the early development of blood dyscrasia such as pyrexia and sore throat. A full blood count should be performed if infection is suspected or there is any other clinical evidence of blood dyscrasia. Immediately discontinue cilostazol if there is clinical or laboratory evidence of hematologic abnormalities.
Use in Surgery: Because of cilostazol's platelet aggregation inhibitory effect, it is possible that an increased bleeding risk occurs in combination with surgery (including minor invasive procedures like tooth extraction). If a patient is to undergo elective surgery and antiplatelet effect is not necessary, discontinue cilostazol five days before surgery.
Hepatic Impairment: Patients with moderate or severe hepatic impairment have not been studied in clinical trials. Special caution is advised when cilostazol is administered in such patients.
Renal Impairment: Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%). Special caution should be exercised when cilostazol is used in patients with severe renal impairment (creatinine clearance <25 mL/min).
Effects on Ability to Drive and Use Machines: Cilostazol may cause dizziness. Patients should exercise caution when driving vehicles or operating machinery.
Use in Children: The safety and effectiveness of cilostazol in pediatric patients have not been established.
Use in Elderly: Pharmacokinetic studies have not shown any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites.
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