Claudiex is an antithrombotic agent, an antiplatelet agent for increasing the maximum pain-free walking distance in patients with intermittent claudication who do not have pain at rest and signs of peripheral tissue necrosis (peripheral arterial disease, Fontaine stage II).
Use as second-line therapy for patients in whom lifestyle changes (including smoking cessation and supervised exercise programs) and other appropriate interventions have not resulted in significant improvement in the symptoms of intermittent claudication.
Composition
active ingredient: cilostazol; 1 tablet contains cilostazol 100 mg; excipients: corn starch, microcrystalline cellulose, carmellose calcium, hypromellose, magnesium stearate.
Contraindication
Known hypersensitivity to cilostazol or any component of the drug; Severe renal failure (creatinine clearance 25 ml/min); Moderate or severe hepatic failure; Congestive heart failure; Pregnancy; Any known bleeding tendency (e.g., gastric or duodenal ulcer in the acute stage, recent hemorrhagic stroke (up to 6 months), proliferative diabetic retinopathy, poorly controlled hypertension); Contraindicated in patients with ventricular tachycardia, ventricular fibrillation or multilocular ventricular ectopy, whether or not receiving appropriate therapy; Patients with QT prolongation; History of severe tachyarrhythmia; concomitant treatment with two or more additional antiplatelet agents or anticoagulants (e.g. acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban); unstable angina, myocardial infarction within the last 6 months or coronary intervention within the last 6 months.
Method of application
The recommended dose of the drug is 100 mg 2 times a day. The tablets should be taken 30 minutes before meals or 2 hours after meals in the morning and evening.
Taking the drug with food may increase its maximum plasma concentrations (Cmax), which increases the risk of adverse reactions. Cilostazol should be prescribed by physicians experienced in the treatment of intermittent claudication. If treatment has not been effective within 3 months, the physician should prescribe another therapy. Patients receiving treatment with cilostazol should adhere to lifestyle changes (smoking cessation and exercise) and continue pharmacological interventions (e.g., lipid-lowering and antiplatelet agents) to reduce the risk of cardiovascular events. Cilostazol is not a substitute for these treatments.
Application features
Use during pregnancy or breastfeeding
Pregnancy
There are no confirmed data on the use of cilostazol in pregnant women. Animal studies have shown reproductive toxicity. The potential risk is unknown, therefore cilostazol should not be taken during pregnancy.
Breast-feeding
Animal studies have shown that cilostazol can pass into breast milk. There is no precise data on the passage of cilostazol into breast milk. Given the possible negative effect on the child, the use of the drug during breastfeeding is not recommended.
Fertility
Animal studies have shown that cilostazol does not affect fertility.
Children
The drug is not recommended for use in children due to the lack of data on safety and efficacy.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised, as dizziness is possible when taking the medication.
Adverse reactions
The most common adverse reactions reported in clinical trials were headache (>30%), diarrhea (>15%), and intestinal disturbances (>15%). These reactions were generally mild to moderate in intensity and sometimes improved with dose reduction.
Storage conditions
Store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
Shelf life 3 years.
