Pentoxifylline-NAN enteric-soluble tablets 100mg No. 25×3

Name:
Pentoxifylline-NAN tab.coated.c/r volume 100mg in cont.cell.pack No. 25×3
Description:
Enteric-coated tablets, white, with a biconvex surface. The main active ingredient Pentoxifylline Release form Tablets Pharmacological action Pentoxifylline is a derivative of methylxanthine, improves the rheological properties of blood, reducing increased viscosity. Pentoxifylline, by inhibiting phosphodiesterase with a subsequent increase in 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. There are no studies on the effect of pentoxifylline on cardiac and cerebrovascular morbidity and/or mortality. Indications for use – Chronic peripheral arterial occlusive disease – Fontaine stage IIb – intermittent claudication, in cases where other measures, such as therapeutic walking, angioplasty and / or reconstructive procedures, are not possible or indicated. – Dysfunction of the inner ear caused by circulatory disorders (including hearing loss, sudden hearing loss). – Additional symptomatic treatment of pathological cognitive deficiency in elderly patients (with the exception of Alzheimer’s disease and other types of dementia). Use during pregnancy and lactation Pentoxifylline is not recommended during pregnancy. Pentoxifylline passes into breast milk in small amounts. Due to insufficient experience, it is necessary to weigh the possible risks and benefits when prescribing pentoxifylline in women who are breastfeeding. Precautions In the case of the use of the drug in patients with chronic heart failure, the phase of circulatory compensation should first be reached. At the first sign of anaphylactic / anaphylactoid reactions, treatment should be discontinued and seek medical attention. In patients with systemic lupus erythematosus or other connective tissue diseases, pentoxifylline should be prescribed only after a thorough analysis of the possible risks and benefits. In diabetic patients receiving treatment with insulin or oral hypoglycemic agents, when using high doses of the drug, it is possible to increase the effect of these drugs on blood sugar levels (see section “Interaction with other drugs”). In these cases, the dose of insulin or oral hypoglycemic agents should be reduced and the patient should be monitored especially carefully. Since during treatment with pentoxifylline there is a risk of developing aplastic anemia, regular monitoring of the complete blood count is necessary. Particularly careful monitoring is necessary for patients with severe cardiac arrhythmias, with arterial hypotension, with severe atherosclerosis of the cerebral and coronary vessels, especially with concomitant arterial hypertension and cardiac arrhythmias (in these patients, when taking the drug, attacks of angina pectoris, arrhythmias and a sharp increase in blood pressure are possible) , with renal insufficiency (creatinine clearance less than 30 ml / min), with severe liver failure, with a high bleeding tendency due, for example, to treatment with anticoagulants or blood clotting disorders (see “Contraindications”), with gastric and duodenal ulcers in history, patients who are simultaneously treated with pentoxifylline and antivitamin K (see section “Interaction with other drugs”). The drug contains lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug. Treatment should be carried out under the control of blood pressure. When administered simultaneously with anticoagulants, it is necessary to carefully monitor the indicators of the blood coagulation system. Pentoxifylline should be used with caution in patients with impaired blood clotting (increased risk of bleeding). The administered dose should be reduced in patients with low and unstable blood pressure. Smoking may reduce the therapeutic efficacy of the drug. In patients who have recently undergone surgery, it is necessary to systematically monitor the parameters of the blood coagulation system (INR). Interactions with other drugs Potential additive effect with inhibitors of platelet aggregation: due to the high risk of bleeding, to the simultaneous use of pentoxifylline with inhibitors of platelet aggregation (such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX inhibitors -2, acetylsalicylates, ticlopidine, dipyridamole) should be treated with caution. Anticoagulant activity should be monitored in patients taking pentoxifylline concomitantly with antivitamin K. Simultaneous administration of ciprofloxacin and pentoxifylline may lead to an increase in the serum concentration of pentoxifylline. Increases the effectiveness of antihypertensive drugs (including ACE inhibitors), insulin and oral hypoglycemic drugs (increased risk of hypoglycemia). The risk of hypotension increases when used together with drugs that can cause a decrease in blood pressure (for example, drugs containing nitro compounds). Cimetidine increases the plasma concentration of pentoxifylline (risk of side effects). It is not recommended to take pentoxifylline simultaneously with ketorolac, as the risk of bleeding and / or prolongation of prothrombin time increases. The simultaneous administration of pentoxifylline and theophylline may lead in some patients to an increase in theophylline plasma concentration and a subsequent increase in the side effects of theophylline. Erythromycin: There is no evidence of a possible interaction between pentoxifylline and erythromycin. However, the simultaneous use of erythromycin and theomycin led to a significant increase in the level of theophylline in the blood serum, accompanied by toxic reactions. Sympathomimetics and xanthines: Co-administration with other xanthines or sympathomimetics may lead to excessive stimulation of the central nervous system. Contraindications Hypersensitivity to pentoxifylline and other xanthine derivatives, acute myocardial infarction, severe cardiac arrhythmia, massive bleeding, hemorrhagic stroke, retinal hemorrhage, hemorrhagic diathesis, gastric and / or intestinal ulcers, pregnancy, lactation, age up to 18 years (efficacy and safety not studied). Composition 1 tablet contains: active ingredient – pentoxifylline – 100 mg; excipients: lactose monohydrate, potato starch, stearic acid, acryl-from (including a copolymer of methacrylic acid with ethyl acrylate, talc, triethyl citrate, sodium lauryl sulfate, sodium carbonate, anhydrous colloidal silicon dioxide, titanium dioxide E 171). Dosing and Administration Enteric-coated tablets are taken orally, swallowed whole, during or immediately after a meal, with plenty of water. Dosage and duration of administration is determined by the doctor individually. The initial dose is usually 100 mg (1 tablet) 3 times a day, followed by an increase in dose to 200 mg (2 tablets) 2-3 times a day. The maximum single dose is 400 mg, the maximum daily dose (orally + parenterally) should not exceed 1200 mg. Patients with low or unstable blood pressure, due to the risk of developing arterial hypotension, begin treatment with small doses, followed by a gradual increase in dose if necessary. 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. The daily dose can be reduced to 100-200 mg and should not exceed 800 mg. 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 due to lack of sufficient clinical experience. If the drug was missed, it should be taken as soon as possible. Do not take a double dose to make up for a missed one. Side effects The following adverse reactions have been reported during clinical trials and post-marketing surveillance. 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 (?1/100) 10,000 to <1/1,000) Very rare (<1/10,000) Frequency not known (cannot be estimated from 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. 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 In a place protected from light and moisture, at a temperature not exceeding 25? Store out of the reach of children.