This is an automatically translated article.
Nibixada drug belongs to the line of drugs sold by doctor's prescription, with the main ingredient being Cilostazol. Nibixada is effective in improving walking distance and walking painlessly in patients with symptoms of claudication in the legs.
1. What is Nibixada drug?
Nibixada medicine has the main ingredient Cilostazo l 100mg content. There are also other excipients such as: Starch, microcrystalline cellulose, Hypromellose, Carmetlose calcium, Magnesium stearate.
2. What is the main use of Nibixada?
Nibixada drug is used in the following cases:
Cilostazol is indicated to improve the maximum walking distance and painless walking on patients with claudication pain in the legs, no pain when not active and people no symptoms of peripheral tissue necrosis (Fontaine stage II peripheral arterial disease). Cilostazol is indicated as replacement therapy, in patients whose lifestyle changes (including smoking cessation and participation in a supervised exercise program) and other appropriate interventions have failed to improve symptoms. intermittent pain in the leg.
3. Dosage - How to take Nibixada
3.1. Dosage The recommended dose is 100mg of Cilostazol x 2 times/day. Patients taking cilostazol should continue to change their lifestyle, exercise, and stop smoking, in addition to pharmacological interventions such as the use of lipid-lowering and antiplatelet drugs to minimize the risk of adverse events. Heart. Dosage reduction to 50 mg Cilostazol twice daily is recommended in patients receiving strong CYP3A4 inhibitors such as azole antifungals, some macrolides, strong CYP2C19 inhibitors such as omeprazole or protease inhibitors. Elderly: No dosage adjustment of Cilostazol is required in the elderly. Children: Safety and efficacy of Cilostazol in children have not been established. Renal impairment: No dose adjustment of Cilostazol is required in patients with creatinine clearance > 25 ml/min. Cilostazol is contraindicated in patients with clearance ≤ 25 ml/min. Hepatic impairment: No dose adjustment of Cilostazol is required in patients with mild liver disease. There are no data in patients with moderate to severe hepatic impairment. Because cilostazol is extensively metabolised by liver enzymes, its use is contraindicated in patients with moderate to severe hepatic impairment. 3.2. How to use Nibixada should be taken 30 minutes before breakfast or dinner or 2 hours after eating. Taking Nibixada with food has been shown to increase peak plasma concentrations (C max), which may lead to an increased incidence of adverse events.
3.3. What to do in case of an overdose of Nibixada? There is no complete information on acute overdose of Nibixada in humans. Signs and symptoms of an overdose of Nibixada can be predictive of headache, diarrhea, arrhythmia, or tachycardia.
Patients should be monitored and treated supportively by gastric emptying by inducing vomiting or gastric lavage if appropriate.
4. Contraindications to taking Nibixada
Nibixada drug should not be used in the following cases:
Patients with a history of allergy or hypersensitivity to Cilostazol or any of the excipients in the drug. Patients with severe renal impairment have creatinine clearance ≤ 25 ml/min. Patients with moderate to severe liver failure. The patient has congestive heart failure. Pregnant women. Patients with bleeding tendencies such as: active peptic ulcer, hemorrhagic stroke within the last 6 months, proliferative diabetic retinopathy, poorly controlled hypertension. Patients with a history of ventricular tachycardia, ventricular fibrillation, or multifocal ectopic beats in the ventricles, with or without adequate treatment, and who have a prolonged QT interval. The patient has a history of tachyarrhythmias. Patients who are on concurrent treatment with two or more anticoagulants or antiplatelet agents such as Clopidogrel, Heparin, Acetylsalicylic acid, Warfarin, Acenocuomarol, Dabigatran, Rivaroxaban, Apixaban. Patients with unstable angina, myocardial infarction or coronary intervention within 6 months.
5. Nibixada drug interactions
Caution when combining Nibixada with the following drugs:
Platelet aggregation inhibitor: Cilostazol is a PDE III inhibitor that inhibits platelet aggregation. In a study in healthy subjects, administration of Cilostazol at a dose of 150 mg twice daily for 5 days was not found to prolong bleeding time. Combining aspirin with cilostazol for a short period of less than 4 days showed a 23-25% increase in the inhibitory effect on platelet aggregation due to ADP ex vivo compared to aspirin alone. There was no clear trend for a higher rate of bleeding in patients receiving aspirin with cilostazol compared with patients receiving placebo and equivalent aspirin doses. Co-administration of Clopidogrel with Cilostazol had no effect on platelet count, activated partial thromboplastin time, and prothrombin. Caution should be exercised when platelet aggregation inhibitors are co-administered with cilostazol and consideration should be given to periodic monitoring of bleeding time. Particular attention should be paid to patients receiving multiple antiplatelet agents. Warfarin-like oral anticoagulants: The study results when using a single dose, there was no inhibition of warfarin metabolism or effects on coagulation parameters such as aPTT, PT, bleeding time. However, caution should be exercised in patients receiving both Cilostazol and other anticoagulants and requires frequent monitoring of bleeding risk. Co-administration of a single dose of Ketoconazole and Cilostazol 100 mg resulted in a 117% increase in Cilostazol AUC, along with a 15% decrease in the Dehydro metabolite AUC and an 87% increase in the 4'-trans-hydroxy metabolite AUC, resulting in total activity 32% increase in potency compared with Cilostazol alone. Co-administration of cilostazol 100 mg twice daily with Diltiazem 180 mg once daily (CYP3A4 inhibitor) resulted in a 44% Cilostazol AUC. Co-administration did not affect the bioavailability of the dehydrogen metabolite, but the AUC of the 4'-trans-hydroxy metabolite was increased by 40%. In patients in clinical trials, co-administration with Diltiazem was shown to increase the AUC of Cilostazol by 53%. A single dose of Cilostazol 100 mg with 240 ml of grapefruit juice did not significantly affect the pharmacokinetics of Cilostazol. A single dose of Cilostazol 100 mg on day 7 of once-daily administration of Omeprazol - a CYP2C19 inhibitor increased the AUC of Cilostazol by 26%, while the AUC of the Dehydro metabolite increased by 69% and the AUC of the 4'-trans metabolite. β-hydroxy was reduced by 31%, resulting in a 42% increase in total potency compared with Cilostazol alone. Cytochrome P450 substrate: Cilostazol was shown to increase the AUC of Lovastatin (a CYP3A4 sensitive substrate) and its β-hydroxy acid by 70%. Caution should be exercised when using Cilostazol concurrently with Cisapride, Halofantrin, Pimozide, ergot derivatives. Caution should be exercised in the case of concomitant use of Cilostazol with Simvastatin. Cytochrome P450 enzyme inducers: The effects of inducers of CYP3A4 and CYP2C19 such as St. John's wort, Carbamazepine, Phenytoin, Rifampicin on the pharmacokinetics of Cilostazol have not been evaluated. Patients should be closely monitored when Cilostazol is administered with inducers of CYP3A4 and CYP2C19 because the antiplatelet effect may be altered. In clinical studies, smoking increased the plasma concentration of Cilostazol by 18%.
6. What side effects does Nibixada cause?
During the use of Nibixada, patients may experience some side effects such as:
Headache (> 30%), diarrhea with abnormal stools (> 15%). Tachycardia, peripheral edema Increased risk of bleeding The risk of intraocular bleeding is higher in patients with diabetes.
7. Notes when using Nibixada
The appropriateness of treatment with Nibixada in conjunction with other therapeutic measures such as vascular redistribution should be carefully considered. Cilostazol active ingredient in the drug can cause arrhythmia, tachycardia or hypotension. Cilostazol's increase in heart rate is about 5-7 beats/min, which in at-risk patients can lead to angina. Patients with an increased risk of cardiac adverse events due to increased heart rate, such as patients with stable coronary artery disease, should be carefully monitored during treatment with Cilostazol, when Cilostazol is used in patients with Unstable angina, or myocardial infarction/coronary intervention within 6 months, or a history of severe tachyarrhythmias, is contraindicated to the use of Cilostazol. Caution should be exercised when prescribing Cilostazol in patients with ventricular or atrial ectropion and in patients with atrial fibrillation or atrial flutter. Patients should inform their doctor or pharmacist if there is bleeding or easy bruising during treatment. If retinal bleeding occurs, treatment with cilostazol should be discontinued. If the patient is to undergo an elective surgery and the antiplatelet effect is not necessary, Nibixada should be discontinued 5 days before surgery. If an infection is detected or clinical signs of hematopoietic disorder are present, a complete blood count should be performed and Nibixada should be discontinued immediately if clinical or subclinical symptoms of hematologic abnormalities occur. Caution is advised when co-administering a CYP3A4 and CYP2C19 inhibitor or inducer or a CYP3A4 substrate with cilostazol. Caution should be exercised when Nibixada is used concomitantly with any agent that causes hypotension due to the potential for hypotension with reflex tachycardia. Caution should be exercised when administering Nibixada with other platelet aggregation inhibitors. Only use Nibixada in patients who have made lifestyle changes such as scientific exercise, eating right and stopping smoking but still not improving their condition. Cilostazol should not be used in patients with serious arrhythmias, heart attacks, unstable angina, patients who have had coronary artery bypass graft surgery, or patients taking two or more anticoagulants, or antiplatelet drugs such as aspirin and clopidogrel. In case of pregnancy, the use of Nibixada is not recommended because there are insufficient data on the use of Cilostazol in pregnant women, and it is not clear that the drug poses a harmful risk to humans. Nibixada is not recommended during lactation, as Cilostazol has been reported in breast milk in animal studies. However, the excretion of Cilostazol in humans is unknown. Cilostazol should be used with caution before driving or operating machinery as its side effects can cause dizziness.
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