Ipaton 250mg 20 tablets — Made in Hungary — Free Delivery

Pharmacological properties

Ticlopidine ([5- (2- [chlorophenyl) -4,5,6,7, -tetrahydrothieno [3,2-c] pyridine hydrochloride) is an antiplatelet agent with a peculiar pharmacological profile (mechanism of action). ticlopidine exhibits an antagonistic effect against ADP, inhibits platelet aggregation and adhesion caused by ADP, as well as other factors (arachidonic acid, collagen, thrombin, platelet activating factor), and increases platelet disaggregation.

The effect of inhibition of platelet aggregation can be observed as early as 2 days after taking the preparation at a dose of 250 mg 2 times a day. The maximum antiplatelet effect is noted on the 5-8th day of treatment.

Ticlopidine reduces the level of fibrinogen and blood viscosity in patients with chronic obliterating diseases of the arteries of the lower extremities; normalizes platelet adhesion, erythrocyte elasticity and beta-thromboglobulin release in patients with diabetes mellitus. After discontinuation of the preparation, its therapeutic effect persists for at least 1 week. The mechanism of action has not been definitively determined. It is believed that the preparation interacts with glycoprotein IIb / IIIa by inhibiting the binding of fibrinogen to activated platelets. The preparation does not affect the metabolism of prostanoids.

After a single oral administration in a therapeutic dose, ticlopidine is rapidly and almost completely absorbed. The maximum concentration in blood plasma is reached after 2 hours. The maximum bioavailability of the preparation is observed when it is taken after meals. Equilibrium concentration in blood plasma is achieved after 7-10 days of daily intake at a dose of 250 mg 2 times a day. The effect of inhibition of platelet aggregation does not depend on the level of the preparation in the blood plasma. About 98% of ticlopidine binds reversibly to blood plasma proteins. Ticlopidine is rapidly metabolized in the body to form one active metabolite. It is excreted mainly in the urine (50-60%) and bile (23-30%). The half-life is 30-50 hours.

Indications

Prevention of cerebrovascular and cardiovascular acute ischemic complications in patients with impaired cerebral and peripheral arterial circulation.

Prevention and correction of platelet dysfunctions caused by extracorporeal circulation during surgery and hemodialysis.

Prevention of occlusion after coronary stent implantation.

The use of Ipaton for the indicated indications is recommended primarily for patients with intolerance or allergy to acetylsalicylic acid or in case of ineffectiveness of its treatment.

Application

The usual adult dose is 1 tablet 2 times a day with meals. for elderly patients - the usual dose for adults. tablets are not chewed, washed down with a sufficient amount of liquid (water, juice). the duration of treatment is set individually.

In order to prevent occlusion after coronary stent implantation, it is recommended to start treatment immediately before or immediately after stent implantation, 1 tablet of Ipaton 2 times a day in combination with 100–325 mg of acetylsalicylic acid per day. The duration of the combined treatment is at least 1 month.

Contraindications

Hypersensitivity to ticlopidine and / or other ingredients of the preparation ; hemorrhagic diathesis; blood diseases, accompanied by an increase in bleeding time; organic lesions with a tendency to bleeding (exacerbation of peptic ulcers of the stomach and duodenum, hemorrhagic stroke in acute and subacute periods); leukopenia, thrombocytopenia and agranulocytosis (including history); high-dose heparin treatment; liver disease with clinical manifestations of hepatitis or jaundice; During pregnancy and breastfeeding; children and adolescents under the age of 14.

In no case should the preparation be used as a means of preventing thromboembolism in healthy patients.

Side effects

Hyperemia and nosebleeds are the most common hemorrhagic complications. in isolated cases, intra- and postoperative bleeding occurred.

From the hematopoietic system

Neutropenia, severe neutropenia (450 / mm3 neutrophilic leukocytes), agranulocytosis (in the first 3 months of treatment). Occasionally - bone marrow aplasia, pancytopenia, thrombocytopenia (80,000 / mm3). In some cases, thrombotic thrombocytopenic purpura (TTP, Moshkovich syndrome), as well as hemolytic anemia, may occur.

From the gastrointestinal tract

Most often - nausea and diarrhea. Diarrhea is usually mild, short-lived, and occurs most often in the first 3 months of treatment. As a rule, this side effect disappears within 1-2 weeks, and there is no need to stop treatment with Ipaton. Very rarely, diarrheal colitis (including lymphocytic colitis) can develop. Treatment should be discontinued if the disease is severe and prolonged.

Skin reactions

During the first 3 months of therapy - skin rashes (maculopapular or urticaria, often accompanied by itching). Most often, skin changes disappear in the first few days after stopping treatment, but in rare cases they can spread. Very rarely, erythema multiforme and Stevens-Johnson syndrome can develop.

From the liver

Rarely - hepatitis and cholestatic jaundice, more often in the 1st month of treatment. After stopping therapy with Ipaton, liver function is restored.

Immunological reactions

Rarely - allergic reactions, anaphylaxis, Quincke's edema, arthralgia, vasculitis, lupus syndrome, nephropathy, allergic interstitial pneumonia.

Other side effects

Very rarely, dizziness, headache, peripheral neuropathy, weakness, loss of appetite occur. Occasionally - lethargy, decreased concentration, tinnitus, tachycardia, nervousness.

Special instructions

The preparation can cause severe and sometimes fatal hematological reactions (neutropenia / agranulocytosis, thrombotic thrombocytopenic purpura), as well as hemorrhage only in the following cases:

• inadequate clinical and hematological monitoring;
• late diagnosis and improper monitoring of the patient's condition with the appearance and development of side effects;
• simultaneous use of NSAIDs that inhibit platelet aggregation, salicylates and anticoagulants. However, when implanting a coronary stent, Ipaton should be used in combination with acetylsalicylic acid (100–325 mg / day) for at least 1 month after surgery.

At the beginning of therapy, as well as every 2 weeks during the first 3 months of treatment, hematological monitoring is necessary (complete blood count with determination of the leukocyte formula, determination of platelet levels, bleeding time).

In the case of a reasonable termination of treatment with Ipaton in the first 3 months of therapy, a repeated hematological examination should be performed within 15 days after the termination of treatment with the preparation. There were isolated cases of severe side effects from the hematopoietic organs after the 3rd month of treatment with ticlopidine.

In case of neutropenia (the level of neutrophilic granulocytes is 1500 / mm3), thrombocytopenia (the level of platelets is 100,000 / mm3), treatment should be stopped immediately and hematological monitoring of the patient's condition should be carried out until the indicators return to normal.

The decision to resume treatment with Ipaton should be based on an assessment of clinical signs and laboratory data.

In the case of a complication such as thrombotic thrombocytopenic purpura (TTP, Moshkovich syndrome), thrombocytopenia, hemolytic anemia, neurological symptoms, renal dysfunction and fever are noted. TTP develops suddenly and is most common in the first 8 weeks of treatment. Since this complication can be fatal, it is necessary to consult a hematologist for the timely diagnosis of this complication if it is suspected. Plasmapheresis improves the prognosis regarding the outcome of this complication.

The preparation should be used with extreme caution under medical supervision in patients with a tendency to hemorrhage / bleeding.

In case of planned surgical interventions (except in cases of an unconditional need for antiplatelet therapy) due to the risk of excessive bleeding, it is necessary to stop using the preparation at least 10 days before the planned operation.

In the case of emergency surgery, the risk of increased bleeding time can be reduced by administering 0.5–1.0 mg / kg body weight of methylprednisolone IV (repeated if necessary) and / or 0.2–0.4 μg / kg body weight of desmopressin and / or platelet-rich blood plasma.

Since ticlopidine is extensively metabolized by the liver, the treatment of patients with liver pathology requires special care, and in certain cases, dose reduction. Therapy should be discontinued if hepatitis or jaundice develops. The use of the preparation is contraindicated in severe hepatic impairment.

Ticlopidine is well tolerated by patients with mild to moderate renal impairment. In severe renal failure, the elimination of ticlopidine decreases, and the concentration in the serum increases. Therefore, it may be necessary to reduce the dose of ticlopidine, and with the development of hematological side effects - to stop treatment.

Therapy should be discontinued if prolonged and / or excessive diarrhea and nausea occur.

Patients should be warned about the need to inform the doctor about taking Ipaton before any surgical intervention or surgical dental manipulation. Patients should be warned about the need for immediate medical advice in case of any allergic skin reactions, bleeding, hematoma, fever, pharyngitis, wounds on the oral mucosa, sore throat, persistent diarrhea, jaundice. Treatment should be discontinued if any of these side effects occur.

A blood test should be done immediately if fever, pharyngitis, or wounds to the oral mucosa appear. The decision to discontinue or continue treatment is based on an assessment of the results of hemogram indicators.

Sometimes taking the preparation can cause dizziness, weakness, lethargy, tinnitus, and reduce the ability to concentrate.

The restriction or prohibition of driving vehicles and performing work requiring increased attention should be determined individually.

Interactions

Special care should be taken when using ticlopidine in combination with the following preparations:

theophylline (increases the level of theophylline in the blood plasma). If necessary, the combined use should control the level of theophylline in the blood plasma;

digoxin (the level of digoxin in the blood plasma decreases by about 15%);

phenytoin (the level of phenytoin in the blood plasma rises). It is recommended to monitor the concentration of phenytoin in blood plasma;

cyclosporine (simultaneous administration can lead to a decrease in the concentration of cyclosporine in the blood plasma, which requires careful monitoring).

Due to the increased risk of hemorrhage with the combined use of Ipaton and the following preparations, special care is required and constant laboratory monitoring is required: NSAIDs; oral anticoagulants (INR should be checked more often - international normalized ratio); heparin preparations (in the case of unfractionated heparin, regular monitoring of the time of formation and activity of thromboplastin is necessary); antiplatelet preparations, such as salicylic acid derivatives.

In healthy patients, prolonged use of phenobarbital does not affect the antiplatelet effect of ticlopidine.

There were no clinically significant preparation interactions while taking ticlopidine with β-adrenergic receptor blockers, calcium channel blockers and diuretics.

Overdose

Symptoms: no cases of overdose have been described. any additional manifestations, except for the known effect of the preparation on the blood coagulation system, are not expected with an overdose of ticlopidine.

Treatment: remove from the body the remnants of the preparation that has not yet been absorbed, induce vomiting, rinse the stomach.

Patients need close supervision.

When bleeding occurs, desmopressin or platelet transfusion is prescribed to suppress the effect of ticlopidine.

Storage conditions

At temperatures up to 25 ° C.