Pletol (cilostazol) tablets 100 mg. №60

Description

Pletol Storage
active substance: cilostazol;
1 tablet contains cilostazol 50 mg;
tablets of 100 mg: excipients: corn starch, hydroxymethylpropylcellulose E 5, microcrystalline cellulose 101, magnesium stearate, calcium carmellose.

Dosage form
Tablets.

Pharmacological properties
Cilostazol is an inhibitor of platelet aggregation. Pletol improves exercise tolerance, which is assessed by the absolute distance between intermittent claudication (or maximum walking distance, MDH) and the initial intermittent claudication distance (or painless walking distance, BDH) in treadmill testing. According to the results of studies at different loads, a significant absolute improvement of 42 meters of maximum walking distance (MDH) was found when using the drug compared to that when taking placebo. This corresponds to a relative improvement of 100% compared with placebo. This effect was slightly lower in patients with diabetes.
Cilostazol has a vasodilatory effect, which was confirmed by measuring blood flow to the lower extremities using tensometric plethysmography. Cilostazol also inhibits smooth muscle cell proliferation and inhibits the platelet-derived growth factor and PF-4 platelet release reaction in human platelets.
Studies have shown that cilostazol causes reversible inhibition of platelet aggregation. Inhibition is effective against a number of aggregates (including arachidonic acid, collagen, ADP and adrenaline), in patients the inhibition lasts up to 12 hours, and after completion of cilostazol recovery of aggregation took place within 48-96 hours without a rebound effect (hyperaggregation). The effect of cilostazol on lipids circulating in blood plasma has also been established. Taking the drug lowers triglycerides and raises HDL-cholesterol. Long-term use of the drug did not cause an increase in mortality among patients compared with placebo.

Indication
To increase the maximum painless walking distance in patients with intermittent claudication who do not have pain at rest and signs of peripheral tissue necrosis (peripheral artery disease, stage II according to Fontaine).

Contraindication:

• known hypersensitivity to cilostazol or any component of the drug;
• severe renal insufficiency (creatinine clearance £ 25 ml / min);
  moderate or severe liver failure;
• congestive heart failure;
• pregnancy;
• any known predisposition to bleeding (eg active peptic ulcer, recent hemorrhagic stroke (within 6 months), proliferative form of diabetic retinopathy, poorly controlled hypertension);
• ventricular tachycardia, ventricular fibrillation or a history of multifocal ventricular ectopia in patients who have undergone or have not undergone appropriate therapy, as well as prolongation of the QT interval;
• severe tachyarrhythmia in the anamnesis;
• concomitant treatment with two or more additional antiplatelet agents or anticoagulants (eg acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban);
• unstable angina, myocardial infarction in the last 6 months or coronary intervention in the last 6 months.

Use during pregnancy or breastfeeding
There are no confirmed data on the use of cilostazol in pregnant women, the potential risk is unknown. The drug is not used during pregnancy.
Cilostazol can pass into breast milk, exact data are not available. Given the possible adverse effects on the child, the use of the drug during breastfeeding is not recommended. If treatment with cilostazol is necessary, breast-feeding should be discontinued.

Method of application and dosage
The recommended dose of the drug Pletol is 50 mg 2 times a day. The tablets are taken 30 minutes before a meal or 2 hours after a meal in the morning and evening.
Taking the drug with food may increase its maximum plasma concentrations, which increases the risk of adverse reactions. Significant improvement in patients is observed after taking the drug for 16-24 weeks, sometimes improvement was noted after treatment for 4-12 weeks. If within 6 months the treatment has not been effective, the doctor must prescribe another therapy.
Patients with renal insufficiency
No special dosage adjustment is required for patients with creatinine clearance> 25 ml / min. Cilostazol is contraindicated in patients with creatinine clearance ≤ 25 ml / min.
Patients with hepatic insufficiency
No dose adjustment is required for patients with mild liver disease. No data are available in patients with moderate or severe hepatic impairment. Because cilostazol is actively metabolized by liver enzymes, it is contraindicated in patients with moderate or severe hepatic impairment.
Elderly patients
There is no need for dose adjustment for this category of patients.

Children
The drug Pletol is not recommended for use in children due to lack of data on safety and efficacy.

Overdose
Information on acute overdose is limited. Severe headache, diarrhea, tachycardia and cardiac arrhythmias are possible. Patients should be monitored and given maintenance therapy. It is necessary to empty the stomach by inducing vomiting or gastric lavage.

Side effects:

• The following side effects may sometimes occur with cilostazol.
• From the circulatory and lymphatic systems: often – bruises; infrequently – anemia; rarely – prolonged bleeding time, thrombocytosis; isolated cases – bleeding tendency, thrombocytopenia, granulocytopenia, agranulocytosis, leukopenia, pancytopenia, aplastic anemia.
• From the immune system: infrequently – allergic reactions.
• From the digestive and metabolic systems: often – edema (peripheral edema or facial edema); infrequently – hyperglycemia, diabetes mellitus; isolated cases – anorexia.
• From the psyche: infrequently – anxiety.
• From the nervous system: very often – a headache; often – dizziness; infrequently – insomnia, unusual dreams; isolated cases – paresis, hypoesthesia.
• From the eyes: isolated cases – conjunctivitis.
• From the hearing organs: isolated cases – tinnitus.
• From the cardiovascular system: often – palpitations, tachycardia, angina, arrhythmia, ventricular arrhythmias; uncommon – myocardial infarction, atrial fibrillation, congestive heart failure, supraventricular tachycardia, ventricular tachycardia, loss of consciousness, ocular hemorrhage, nosebleeds, gastrointestinal bleeding, indeterminate bleeding, orthostatic hypotension; isolated cases – hot flashes, hypertension, hypotension, cerebral hemorrhage, pulmonary hemorrhage, muscle hemorrhage, airway hemorrhage, subcutaneous hemorrhage.
• From the respiratory tract: often – rhinitis, pharyngitis; infrequently – dyspnea, pneumonia, cough; isolated cases – interstitial pneumonia.
• From the digestive tract: very often – diarrhea, defecation disorders; often – nausea, vomiting, dyspepsia, flatulence, abdominal pain; infrequently – gastritis.
• From the hepatobiliary system: isolated cases – hepatitis, liver dysfunction, jaundice.
• From the skin and subcutaneous tissues: often – rash, itching; single – eczema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
• From the urinary system: rarely – renal failure, renal dysfunction; isolated cases – hematuria, pollakiuria.
• General disorders: often – chest pain, asthenia; infrequently – myalgia, chills; single hyperthermia, malaise, pain.
• Laboratory tests: isolated cases – increased levels of uric acid, blood urea, creatinine.

Expiration date
3 years.

Storage conditions
Store Pletol at a temperature not exceeding 25 ° C in the original package.
Keep out of reach of children.