Bestazol 50/Bestazol 100

Bestazol 50/Bestazol 100

cilostazol

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Cilostazol
Indications/Uses
Ischemic symptoms, including ulceration, pain & coldness of the extremities, in chronic arterial occlusion. Prevention of recurrence of cerebral infarction (excluding cardiogenic cerebral embolism).
Dosage/Direction for Use
Adult 100 mg bid. Coadministration w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, erythromycin & diltiazem; CYP2C19 inhibitors eg, omeprazole Reduce dose to 50 mg bid.
Administration
Should be taken on an empty stomach: Take at least 30 min before or 2 hr after meals.
Contraindications
Hypersensitivity. CHF, hemostatic disorders or active bleeding (eg, bleeding peptic ulcer & intracranial bleeding). Pregnancy.
Special Precautions
May increase heart rate, premature ventricular contractions & ventricular tachycardia. Do not use if symptoms of CHF are present. CV risk on prolonged treatment. Contraindicated in patients w/ history of hypersensitivity. Patients w/ cerebral infarction. Control BP during treatment in patients w/ cerebral infarction w/ high BP. Rare cases of thrombocytopenia or leukopenia. Check bleeding times during coadministration w/ clopidogrel. Patients receiving other platelet aggregation inhibitors, CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin & diltiazem) or CYP2C19 inhibitors (eg, omeprazole). Withhold treatment for 4-6 half-lives prior to elective surgical procedures. Moderate or severe hepatic or severe renal impairment (CrCl <25 mL/min). Lactation. Childn. Elderly.
Adverse Reactions
Palpitation, tachycardia, dizziness, headache, vertigo, abdominal pain, abnormal stools, diarrhea, dyspepsia, flatulence, nausea, peripheral edema, musculoskeletal, back pain, myalgia, increased cough, pharyngitis, rhinitis, infection.
Drug Interactions
Increased inhibition of platelet aggregation w/ aspirin. May elevate plasma conc of certain HMG-CoA reductase inhibitors. Decreased Css, max & AUC w/ lovastatin. Clopidogrel. Increased plasma conc & decreased clearance w/ other CYP3A4 isoenzyme inhibitors including certain azole antifungals (eg, fluconazole, itraconazole, ketoconazole, miconazole), certain macrolide antibiotics (eg, erythromycin or clarithromycin but not azithromycin), certain SSRIs (eg, fluoxetine, fluvoxamine, nefazodone, sertraline), certain antiretroviral agents (eg, indinavir), metronidazole, diltiazem & danazol. Decreased metabolism w/ erythromycin & other macrolide antibiotics. Increased plasma conc by diltiazem. Metabolism may be inhibited & plasma conc may be elevated by omeprazole. Increased Cmax w/ grapefruit juice. Synergistic effects w/ Ginkgo biloba. Decreased systemic exposure w/ tobacco smoking.
ATC Classification
B01AC23 - cilostazol ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Bestazol 100 tab 100 mg
Packing/Price
3 × 10's
Form
Bestazol 50 tab 50 mg
Packing/Price
10 × 10's
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