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Cilostazol is an active ingredient used to improve blood circulation problems in the legs (claudication in the legs), relieve muscle pain/cramps that occur with exercise/walking, increase blood flow and oxygen to the muscles. The active ingredient cilostazol is currently present in the drug Pasquale
1. What is Pasquale?
Pasquale drug has the main ingredient is Cilostazol, the content of 100mg is made in the form of tablets. Pasquale drug is a product of Dat Vi Phu Pharmaceutical Joint Stock Company (DAVIPHARM) - VIETNAM, the drug is circulating on the market with registration number VD-21064-14.
2. Indications for the use of Pasquale
Cilostazol is indicated for the improvement of maximal walking distance and pain-free walking in patients with leg claudication, pain-free inactivity, and symptoms of peripheral tissue necrosis. Because. Cilostazol is indicated for use as an alternative therapy in patients whose lifestyle changes (including smoking cessation, participation in a supervised exercise program) and other appropriate interventions cannot Improve symptoms of claudication in the legs.3. Dosage - How to use Pasquale
Dosage: The recommended dose of Pasquale is 100 mg x 2 times/day.
Only physicians experienced in the treatment of claudication of the legs should prescribe Cilostazol to patients. Patients taking Pasquale require continued lifestyle changes (exercise and smoking cessation), and pharmacological interventions (lipid-lowering drugs, antiplatelet agents) to reduce the risk of cardiovascular events. Pasquale is not a substitute for medication. It is recommended that the dose of Pasquale be reduced to 50 mg twice daily in patients receiving strong CYP3A4 inhibitors such as macrolides, azole antifungals, protease inhibitors, strong CYP2C19 inhibitors such as omeprazole. Elderly: There are no special dosage requirements for Pasquale in the elderly. Children: Safety and effectiveness of Pasquale in children have not been established. Renal Impairment: No dosage adjustment of Pasquale is required in patients with creatinine clearance > 25 ml/min. Pasquale is contraindicated in patients with a clearance ≤ 25 ml/min. Hepatic impairment: No dose adjustment of Pasquale is required in patients with mild liver disease. There are no data from Pasquale in patients with moderate to severe hepatic impairment, as cilostazol is extensively metabolised by liver enzymes, therefore Pasquale is contraindicated in patients with moderate to severe hepatic impairment. How to use Pasquale: Should take Pasquale before breakfast or dinner 30 minutes or 2 hours after eating. Taking Pasquale with food increases peak plasma concentrations (Cmax), which may lead to an increased incidence of adverse events.
4. Contraindications to the use of Pasquale
Hypersensitivity to Cilostazol or any of the ingredients in Pasquale .
Patients with severe renal impairment: creatinine clearance ≤ 25 ml/min; Moderate to severe liver failure; Congestive heart failure ; Pregnant women; Patients with bleeding tendencies (active peptic ulcer, hemorrhagic stroke within 6 months), diabetic retinopathy, poorly controlled hypertension; Patients with a history of ventricular tachycardia, ventricular fibrillation, multifocal ventricular ectopic beats, with/without radical treatment, and patients with prolonged QT interval; Patients with a history of tachyarrhythmias; Concomitant treatment with 2 or more anticoagulants or antiplatelet agents (such as acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban); Patients with unstable angina, myocardial infarction or coronary intervention within 6 months.
5. Drug interactions of the drug Pasquale
Platelet aggregation inhibitor: Cilostazol is a phosphodiesterase III inhibitor that inhibits platelet aggregation, using cilostazol 150mg x 2 times / day for 5 days without prolonging bleeding time;
Aspirin: Concomitant use of Pasquale and aspirin for a short period of time ≤ 4 days showed an increased inhibitory effect on platelet aggregation by 23-25% compared with aspirin alone; There was no clear trend for higher bleeding rates in patients receiving Pasquale with aspirin compared with patients receiving placebo with an equivalent dose of aspirin; Clopidogrel and other antiplatelet agents: Concomitant administration of Pasquale and clopidogrel had no effect on platelet count, prothrombin time, or activated partial thromboplastin time (aPTT). Cilostazol is extensively metabolised by CYP enzymes: CYP3A4, CYP2C19 and, to a lesser extent, CYP1A2. The dehydro-metabolite, which is 4-7 times more potent in inhibiting platelet aggregation than Cilostazol, is formed mainly by CYP3A4. Therefore, drugs that inhibit CYP3A4 (macrolid, azole, antifungal, protease inhibitor) or CYP2C19 (proton pump inhibitors - PPIs) increase the pharmacodynamics and may increase the undesirable effects of Pasquale; Administration of cilostazol 100 mg twice daily with Diltiazem 180 mg once daily (CYP3A4 inhibitor) resulted in increased cilostazol AUC.
6. Side effects of the drug Pasquale
The most common adverse reactions of Pasquale are headache (> 30%), diarrhea, abnormal stools (> 15%). These reactions are usually mild to moderate and sometimes subside with a reduction in the dose of Pasquale. There is an increase in the incidence of tachycardia and peripheral edema when Pasquale is used in combination with other cardiovascular drugs that cause reflex tachycardia such as calcium channel blockers dihydropyridines. The adverse event requiring discontinuation of Pasquale in ≥ 3% of patients receiving cilostazol was headache, other events including tachycardia and diarrhea (both 1.1%). Pasquale increases the risk of bleeding and this risk is increased when taken with other risk factors, the risk of intraocular bleeding is higher in people with diabetes.
7. Be careful when using Pasquale
The appropriateness of treatment with Pasquale in conjunction with other therapeutic measures such as vascular redistribution should be carefully considered. Based on the mechanism of action of Pasquale, cilostazol may cause arrhythmia, tachycardia and/or hypotension. Increased heart rate due to Pasquale is about 5-7 beats / min, in at-risk patients can lead to angina; Caution should be exercised when prescribing Pasquale in patients with atrial or ventricular ectropion, in patients with atrial fibrillation or atrial flutter; Due to its platelet aggregation inhibitory properties, the use of Pasquale increases the risk of bleeding during surgery (including tooth extraction). A complete blood count should be performed if an infection is detected or clinical signs of a hematopoietic disorder occur, and Pasquale should be discontinued immediately if there are clinical or laboratory abnormalities related to hematology.
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