COMPOSITION :
Cilostazol Tablet 100 mg, each tablet contains : Cilostazol 100 mg.
DESCRIPTIONS :
Cilostazol with active ingredient Cilostazol is available in 100 mg tablet.
INDICATIONS :
- Treatment of ischemic symptoms, including peptic ulceration, pain and coldness of the extremities, in chronic arterial occlusion.
- Prevention of recurrence of cerebral infarction (excluding cardiogenic cerebral embolism).
DOSAGE AND ADMINISTRATIONS :
The recommended adult dose of Cilostazol tablet is 100 mg twice daily. The dosage may be adjusted according to the age of the patient and the severity of symptoms.
CONTRAINDICATIONS :
- Patients with hemorrhage (e.g., hemophilia, increased capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis and hemorrhage in the vitreous body). (Bleeding tendency may be increased)
- Patients with congestive heart failure. (Condition may be worsened)
- Patients with a history of hypersensitivity to any ingredient of the drug.
- Pregnant women or may possibly become pregnant. (See use during pregnancy, delivery or lactation)
WARNINGS AND PRECAUTIONS :
Careful administration :
- Patients taking anticoagulant drugs (e.g., Warfarin), antiplatelet (e.g., Ticlopidine and Acetylsalicylic acid), thrombolytic (e.g., Urokinase and Alteplase) or prostaglandin E1 or its derivatives (e.g., Alprostadil and Limaprost alfadex).
- Patients during menstruation.
- Patients with bleeding tendency and predisposition to bleeding.
- Patients with coronary artery stenosis.
- Patients with diabetes mellitus or abnormal glucose tolerance.
- Patients with severe hepatic or renal impairment.
- Patients with severe hypertension with consistently high blood pressure.
Important precautions :
- Cilostazol should not be administered to patients with cerebral infarction until their condition has stabilized.
- The dosage should be reduced or the drug discontinued and appropriate corrective measures taken if there is an excessive increase in pulse rate in patients with coronary artery stenosis during treatment with Cilostazol since increased pulse rate could induce angina pectoris.
Use in elderly :
Elderly patients may be physiologically more sensitive to Cilostazol than younger patients. Decrease the dosage may be necessary in prescribing this drug for elderly patients.
Use during pregnancy, delivery or lactation :
- Cilostazol should not be used in pregnant women or who may possibly become pregnancy.
- Nursing should be suspended during use of the drug by nursing women.
Pediatric use :
The safe use of Cilostazol in infants, premature babies, newborns, sucking infants and children has not been established.
DRUG INTERACTIONS :
- Anticoagulant drugs (e.g., Warfarin), antiplatelet (e.g., Acetylsalicylic acid and Ticlopidine), thrombolytic (e,g., Urokinase and Alteplase) or prostaglandin E1 and its derivatives (e.g., Alprostadil and Limaprost alfadex) can increase the bleeding tendency if bleeding occurs.
- Erythromycin, Ritonavir, Itraconazole, Miconazole, Cimetidine, Diltiazem, Omeprazole and grapefruit juice can increase the Cmax and AUC Cilostazol.
ADVERSE REACTIONS :
- Clinically significant adverse reactions :
- Congestive heart failure, myocardial infarction, angina pectoris and ventricular tachycardia.
- Bleeding tendency.
- Pancytopenia, agranulocytosis and thrombocytopenia.
- Interstitial pneumonia.
- Hepatic dysfunction and jaundice.
- Other side effects :
- Hypersensitivity : Rash, eruption, urticaria, pruritus and photosensitivity.
- Cardiovascular : Palpitations, tachycardia, hot flushes, blood pressure increased, arrhythmias, atrial fibrillation, supraventricular tachycardia, supraventricular extrasystoles, ventricular extrasystoles, blood pressure decreased.
- CNS : Headache, dizziness, numbness, insomnia, sleepiness and tremors.
- Gastrointestinal : Abdominal pain, nausea, vomiting, anorexia, diarrhea, heartburn and abdominal distention.
- Hematological : Anemia, leucopenia.
- Bleeding tendency : Subcutaneous hemorrhage, hematuria.
- Hepatic : Increase in AST (GOT), ALT (GPT), alkaline phosphatase and LDH.
- Renal : Increase in blood urea nitrogen, creatinine and uric acid.
- Other : Sweating, edema, chest pain, blood sugar increase, tinnitus, pain, weakness, malaise, conjunctivitis, increased micturition frequency and fever.
PRESENTATIONS :
Cilostazol Tablet 100 mg Box, 10 blisters @ 10 tablets Reg. No. GKL0502337810A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
