Vasonite prolonged action tablets p/o 600mg №10×2

NameVazonite table prolong. action p/o 600mg in a blister pack No. 10×2 The main active ingredient Pentoxifylline Release form Tablets Dosage 0.6 g It improves the rheological properties of blood by reducing the increased viscosity. Pentoxifylline, by inhibiting phosphodiesterase with a subsequent increase in the content of intracellular cAMP and ATP, improves the ability of erythrocytes to deform and prevents their aggregation. It exhibits an antithrombotic effect by inhibiting platelet aggregation and reducing pathologically elevated levels of fibrinogen in blood plasma. Prevents the activation of leukocytes and the adhesion of leukocytes to the vascular endothelium. Indications for use Chronic occlusive diseases of the peripheral arteries (intermittent claudication) in patients with circulatory reserve in cases where other methods of treatment are impossible or not indicated. Dysfunction of the inner ear caused by circulatory disorders. Dosage and administration Dosage and duration of administration is determined by the doctor individually. The usual dose is 1 tablet (600 mg) once a day. If necessary, the dose can be increased to 1 tablet (600 mg) 2 times a day. In addition to oral administration, additional administration of pentoxifylline in the form of infusion therapy is possible. The maximum daily dose of pentoxifylline (orally + parenterally) should not exceed 1200 mg. Patients with low or unstable blood pressure, due to the risk of arterial hypotension, it is recommended to start treatment with the lowest dose. Patients with impaired renal function: in case of impaired renal function (creatinine clearance <30 ml / min), the dose should be reduced to 50-70% of the standard, depending on individual tolerance. Patients with impaired liver function: in case of severe hepatic impairment, a dose reduction is required, taking into account individual tolerability. Elderly patients: given that the elimination rate may decrease in elderly patients, caution is advised, if necessary, adjusting the dose depending on the severity of the disease and the tolerability of the drug. Children and adolescents: the drug is not prescribed to children and adolescents under 18 years of age due to lack of sufficient clinical experience. Use during pregnancy and lactation During pregnancy, the use of Vasonite is contraindicated. If necessary, the use of the drug during lactation should stop breastfeeding. Precautions Vasonite should be used with caution in patients with an increased risk of retinal hemorrhage due to factors such as diabetes and hypertension. In case of retinal hemorrhage, treatment should be stopped immediately. With caution, the drug Vasonit® should be taken in the following cases: - sclerosis of the coronary and cerebral vessels in combination with hypertension, - severe cardiac arrhythmia, - severe hypertension, - systemic lupus erythematosus (SLE) and mixed connective tissue damage. In addition, caution is required when taking: - patients with impaired renal function (creatinine clearance <30 mg / min), - patients with hypotension (there is a risk of further strengthening the hypothesis), - patients with severe liver damage (there is a risk of cumulation), - patients with diabetes mellitus (there is a risk of deterioration of the metabolic status). - Patients with an increased tendency to bleed due to anticoagulants or blood coagulation disorders, - Patients who have undergone surgery. In patients with impaired renal function, the dose should be reduced. Moreover, dose adjustment is necessary when taking antihypertensive drugs concomitantly. In patients with hypotension or circulatory dysregulation, the dose should be reduced gradually. A significant dose reduction is also possible. Due to the risk of aplastic anemia while taking Vasonit®, blood tests should be performed regularly. Patients with heart failure should be treated appropriately before treatment. At the first signs of anaphylactic / anaphylactoid reactions, the use of the drug should be stopped immediately and consult a doctor. Interaction with other drugs Combinations requiring precautions for use: Antihypertensive drugs Pentoxifylline may increase the effect of antihypertensive drugs or drugs that have a possible antihypertensive effect: lowering blood pressure may increase. Anticoagulants Pentoxifylline may enhance the effect of anticoagulants. In patients with an increased bleeding tendency due to concomitant use of anticoagulants, any bleeding that occurs may be exacerbated. Cases of increased anticoagulation effect have also been reported in patients who simultaneously took pentoxifylline and vitamin K antagonists (coumarins). Therefore, close monitoring of anticoagulant activity in such patients (eg, regular checks of prothrombin time and INR) is recommended, especially at the start of pentoxifylline therapy or when the dose is changed. Platelet aggregation inhibitors Due to an increased risk of bleeding, caution should be exercised when taking an inhibitor of platelet aggregation (such as clopidogrel, epifibatide, tirofiban, epoprostenol, iloprost, absiximab, anagrelide, non-steroidal anti-inflammatory drugs other than selective COX-2 inhibitors, acetylsalicylates, acetylsalicylic acid / lysine acetylsalicylate, ticlopidine, dipyridamole) with pentoxifylline. Oral antidiabetic agents, insulin Pentoxifylline may enhance the effect on lowering blood sugar levels, causing hypoglycemic reactions. Glycemic control should be carried out taking into account the individual case. Theophylline It is possible to increase the level of theophylline in the blood, therefore, during the treatment of respiratory diseases, the undesirable effects of theophylline may increase. Increased risk of theophylline overdose. If clinical symptoms appear, it is necessary to adjust the dose of theophylline during and after treatment with pentoxifylline. Cimetidine Elevated plasma levels of pentoxifylline and active metabolite I are possible, as well as an increased effect of pentoxifylline. Ciprofloxacin When taken concomitantly with ciprofloxacin in some patients, the concentration of pentoxifylline in the blood serum may increase. Therefore, there may be an increase and intensification of adverse reactions associated with simultaneous administration. Contraindications Acute myocardial infarction, massive bleeding, acute hemorrhagic stroke, retinal hemorrhage, hypersensitivity to pentoxifylline and other methylxanthine derivatives (caffeine, theophylline, theobromine) or any auxiliary component of the tablet, hemorrhagic diathesis, gastric and / or intestinal ulcers, severe cardiac arrhythmias , childhood. One tablet contains the active substance pentoxifylline 0.6 g (600 mg), as well as excipients: hypromellose, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, macrogol 6000, talc (E553), titanium dioxide (E171), polyacrylate dispersion 30%. Overdose Symptoms: nausea, dizziness, lowering blood pressure, fever (chills), loss of consciousness, tonic-clonic convulsions are possible. Vomiting "coffee grounds", arrhythmias, areflexia. Treatment: gastric lavage, symptomatic, there is no specific antidote. Side effects The following categories are used to indicate the frequency of adverse events: Very common (?1/10) Common (?1/100 to <1/10) Uncommon (?1/1000 to <1/100) Rare (?1 /10,000 to <1/1,000) Very rare (<1/10,000) Frequency not known (cannot be estimated from the available data). Blood and lymphatic system disorders Very rare: thrombocytopenia, thrombocytopenic purpura and potentially fatal aplastic anemia (pancytopenia). Frequency unknown: leukopenia/neutropenia. Regular monitoring of the complete blood count is recommended. Immune system disorders Uncommon: Skin hypersensitivity reactions (see Adverse Skin Effects). Very rarely: severe anaphylactic or anaphylactoid reactions that develop within a few minutes after taking pentoxifylline, such as angioedema, bronchospasm, anaphylactic shock. At the first signs of a hypersensitivity reaction, you should immediately stop taking the drug and inform your doctor. Mental disorders Uncommon: agitation, sleep disturbance. Nervous system disorders Uncommon: dizziness, tremor, headache. Very rare: paresthesia, convulsions, intracranial hemorrhage. Symptoms of aseptic meningitis: Patients with autoimmune diseases (SLE, mixed connective tissue diseases) are prone to these symptoms. In all observed cases, the symptoms were reversible after discontinuation of pentoxifylline. On the part of the organ of vision Infrequently: visual disturbances, conjunctivitis. Very rare: retinal hemorrhage, retinal detachment. If hemorrhage in the retina during therapy with pentoxifylline, you should immediately stop taking the drug. Cardiac disorders Uncommon: cardiac arrhythmia, eg tachycardia. Rare: angina pectoris, dyspnoea. Vascular disorders Common: flushing. Rare: Bleeding (see Adverse Events for Various Organs). Gastrointestinal disorders Common: nausea, vomiting, bloating, heaviness in the stomach, diarrhea. Rarely: gastric and intestinal bleeding. Frequency unknown: constipation, increased salivation. Liver and biliary tract disorders Very rare: intrahepatic cholestasis, elevated liver enzymes (see Laboratory and Instrumental Studies). Skin and subcutaneous tissue disorders Uncommon: itching, redness, allergic rash. Rarely: hemorrhages in the skin and subcutaneous tissues. Very rare: epidermal necrolysis, Stevens-Johnson syndrome, sweating. Frequency unknown: rash. Renal and urinary disorders Rare: Genitourinary bleeding. Laboratory and instrumental studies Rarely: low blood pressure, decreased prothrombin time. Very rarely: increased transaminases or alkaline phosphatase, high blood pressure. General disorders Uncommon: fever. Rare: peripheral edema. In case of side effects, it is necessary to stop taking the drug. The patient must inform the doctor in case of side effects, including those not mentioned in this leaflet. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25°C. Keep out of the reach of children.