Trental-tab 400 p / v prolong film. 400mg 20 pieces


Trental-tab 400 p / v prolong film. 400mg 20 pieces



Active substance:
1 tablet contains: pentoxifylline – 400.0 mg.
Povidone – 10.0 mg, gietelloza – 140.0 mg Talc – 12.5 mg Magnesium stearate – 2.5 mg.
shell composition: hypromellose – 10.902 mg titanium dioxide (E 171) – 2,680 mg talc – 0.820 mg macrogol 8000 – 0.550 mg.
Oblong biconvex, film-coated white. On the one hand tablets engraved “ATA”.
Product form:
Prolonged action tablets, film-coated, 400 mg. 10 tablets in blister PVC / aluminum foil. 2 or 6 blisters with instruction for use in a cardboard box.
Hypersensitivity to pentoxifylline, other methylxanthines or any excipient the formulation. Massive bleeding (risk of increased bleeding). Extensive bleeding in the retina of the eye (risk of increased bleeding). Bleeding in the brain. Acute myocardial infarction. Age up to 18 years. Pregnancy (insufficient data). breast-feeding period (insufficient data).
Severe disorders of heart rhythm (arrhythmia risk of deterioration). Hypotension (risk of further blood pressure lowering. See section “Dosage and Administration”). Chronic heart failure. Gastric ulcer and duodenal ulcer. renal dysfunction (creatinine clearance less than 30 mL / min) (risk of accumulation and an increased risk of side effects. See section “Dosage and Administration”). Severe liver disorders (increased risk of accumulation and the risk of side effects. See section “Dosage and Administration”). Recently transferred surgery. The increased risk of bleeding (e.g., disorders in blood coagulation system (risk of a severe bleeding). See section “Interaction with other drugs”). The simultaneous use of anticoagulants (including indirect anticoagulants [antagonist of vitamin K]) (see. See “The interaction with other drugs”). The simultaneous use of the platelet aggregation inhibitor (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs [cyclooxygenase-2 addition of selective inhibitors], acetylsalicylic acid, ticlopidine, dipyridamole) (see. See “The interaction with other drugs”) . The simultaneous use of hypoglycemic agents (insulin and hypoglycemic agents for oral administration) (see. See “The interaction with other drugs”). The simultaneous use of ciprofloxacin (see. See “The interaction with other drugs”). Concomitant use with theophylline (see. See “The interaction with other drugs”).
400 mg
Peripheral arterial occlusive disease or diabetic atherosclerotic origin (e.g., “intermittent” claudication, diabetic angiopathy). Trophic disorders (e.g., leg sores, gangrene). Cerebrovascular accidents (the effects of cerebral arteriosclerosis, such as poor concentration, dizziness, memory impairment), ischemic and post stroke condition. Circulatory disturbances in the network and the choroid. Otosclerosis, degenerative changes in the background pathology of vessels of the inner ear and hearing loss.
Interaction with other drugs
With antihypertensives: pentoxifylline increases the risk of hypotension while the use of antihypertensive agents (e.g., angiotensin-converting enzyme (ACE)), or other drugs having potential antihypertensive effect (e.g., nitrates).
With drugs affecting the clotting of blood: pentoxifylline may exacerbate the effects of drugs influencing blood coagulation (direct and indirect anticoagulants, thrombolytics, antibiotics, such as cephalosporins). In a joint application of pentoxifylline and indirect anticoagulants (vitamin K antagonists) in the post-marketing studies have been cases enhance the anticoagulant action (risk of bleeding). Therefore, in the beginning of the reception of pentoxifylline or changing its dose recommended to control the degree of anticoagulant effect in patients treated with this combination of drugs, for example, to carry out regular monitoring of the INR (international normalized ratio).
With cimetidine: cimetidine increases the concentration of the active metabolite of pentoxifylline and I in the blood plasma (the risk of side effects).
With other xanthines: co-administration with other xanthines can lead to excessive nervous excitement.
With hypoglycaemic drugs (insulin and hypoglycemic agents for oral administration): the hypoglycemic effect of insulin or hypoglycemic agents for oral administration may be enhanced while the use of pentoxifylline (increased risk of hypoglycaemia). There must be strict control of the state of these patients, including regular blood glucose control.
With theophylline: in some patients, while the use of theophylline and pentoxifylline marked increase in the concentration of theophylline. This further can increase or enhance the adverse effects associated with theophylline.
With ciprofloxacin: in some patients, while the use of pentoxifylline and ciprofloxacin pentoxifylline marked increase in plasma concentrations. This further can increase or enhance the adverse effects associated with the use of this combination.
C. Platelet aggregation inhibitors: the simultaneous use of pentoxifylline with platelet aggregation inhibitor (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs [cyclooxygenase-2 addition of selective inhibitors], acetylsalicylic acid, ticlopidine, dipyridamole) may develop a potential additive effect which increases the risk of bleeding. Therefore, because of the risk of bleeding should be used with caution pentoxifylline together with the above-mentioned inhibitors of platelet aggregation (see. Section ”
Carefully “).
Overdose symptoms: dizziness, nausea, vomiting, like “coffee grounds”, drop in blood pressure, tachycardia, arrhythmia, redness of the skin, loss of consciousness, vomiting, areflexia, tonic-clonic seizures. In the case of the above violations is an urgent need to see a doctor.
Treatment is symptomatic. At the first signs of overdose (sweating, nausea, cyanosis) immediately stop taking the drug. If the drug has recently adopted, measures should be provided to prevent further absorption of the drug by its excretion (gastric lavage) or slow absorption (for example, administration of activated charcoal). Particular attention should be directed to maintain blood pressure and respiratory function. When seizures administered diazepam. A specific antidote is not known.
pharmachologic effect
Pharmacological group:
Vasodilating agent.
Preparation Trental® 400 decreases blood viscosity and improves the flow properties of the blood (flowability) due to: improve impaired erythrocyte deformability; reducing platelet aggregation and erythrocytes; reducing the concentration of fibrinogen; reducing the activity of leukocytes, and reducing the adhesion of leukocytes to the vascular endothelium. The active substance formulation contains 400 Trental® xanthine derivative – pentoxifylline. Its mechanism of action is related to inhibition of phosphodiesterase and the accumulation of cyclic adenosine monophosphate (cAMP) in vascular smooth muscle cells of blood corpuscles and cells. Exerting slight myotropic vasodilator action, pentoxifylline somewhat reduces the total peripheral vascular resistance and slightly increasing coronary vessels. Pentoxifylline has a weak positive inotropic effect on the heart. Improves microcirculation in areas of impaired circulation. Treatment with Trental® 400 leads to improvement of symptoms of cerebral blood flow. When the occlusive peripheral arterial disease drug application Trental® 400 results in a lengthening distance away, elimination of night cramps in the calves and disappearance of pain at rest.
After ingestion pentoxifylline is almost completely absorbed. Pentoxifylline is subjected to the effect of “first pass” through the liver. The absolute bioavailability of the initial substance amounts to 19 ± 13%. The concentration of the main active metabolite of 1- (5-hydroxyhexyl) -3,7-theobromine (metabolite I) in plasma twice the original concentration of pentoxifylline. Metabolite I c is pentoxifylline in reversible biochemical redox equilibrium. Therefore, pentoxifylline and metabolite I are considered together as the active unit. Consequently, the availability of the active substance considerably more. Prolonged release of pentoxifylline keeps it constant (Thus, the peakless) concentration in the blood which provides a better tolerability of the drug in the dosage form. The half life of pentoxifylline after ingestion of 1.6 hour. Pentoxifylline completely metabolized and more than 90% is excreted through kidneys in the form of water-soluble unconjugated metabolites.
Patients with impaired renal function: in patients with impaired renal excretion of metabolites is slowed down.
Patients with impaired hepatic function: in patients with impaired liver function the half-life of pentoxifylline is prolonged and the absolute bioavailability is increased.
Pregnancy and breast-feeding
Pregnancy: 400 Trental® drug is not recommended during pregnancy (since insufficient data).
Breastfeeding: pentoxifylline passes into breast milk in small quantities. If necessary, the drug should stop breastfeeding (given the lack of experience of the application).
Conditions of supply of pharmacies
side effects
Below are adverse reactions that have been studied in clinical trials and post-marketing application of the drug (the frequency is unknown).
Disorders of the nervous system: headache, dizziness, aseptic meningitis, seizures.
Mental disorders: agitation, sleep disturbances, anxiety.
Violations of the heart: tachycardia, arrhythmia, lower blood pressure, angina pectoris.
Violations by the vessels, “tides” of blood to the skin, bleeding (including bleeding from vessels in the skin, mucous membranes, stomach, intestines).
Disorders of the digestive system: xerostomia (dry mouth), anorexia, intestinal atony, feeling of pressure and fullness in the stomach, nausea, vomiting, diarrhea, constipation, hypersalivation (excessive salivation).
Violations of the liver and biliary tract: intrahepatic cholestasis, increased activity of “liver” transaminases, increased alkaline phosphatase activity.
Blood disorders and lymphatic system: leukopenia / neutropenia, thrombocytopenia, pancytopenia, gipofibrinogenemia.
Violations by the organ of vision: blurred vision, scotoma.
Violations of the skin and subcutaneous tissue disorders: pruritus, rash, erythema (skin redness), rash, increased nail fragility, swelling.
Disorders of immune system: anaphylactic / anaphylactoid reactions, angioneurotic edema, anaphylactic shock, bronchoconstriction.
special instructions
Treatment should be under the control of blood pressure. In patients with diabetes, taking hypoglycemic agents, the appointment of large doses of pentoxifylline may cause pronounced hypoglycemia (may require dose adjustment of hypoglycemic agents and conduct of glycemic control). In appointing the drug Trental® 400 simultaneously with anticoagulants should be monitored indicators of blood coagulation. In patients who have recently had surgery, requires regular monitoring of hemoglobin and hematocrit. Patients with low and unstable blood pressure is necessary to reduce the dose of pentoxifylline. Elderly patients may require a dose reduction of pentoxifylline (increased bioavailability and reduced clearance rate). The safety and efficacy of pentoxifylline in children are not well understood. Smoking may reduce the therapeutic efficacy of the drug.
Effects on ability to drive and engage in potentially hazardous activities
Given the potential side effects (eg, dizziness), caution should be exercised when driving and classes of potentially hazardous activities.
Storage conditions
Stored in a dry place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
The dosage is set by the doctor according to the individual characteristics of the patient. The usual dose is: one tablet Trental® 400 two or three times a day. The maximum daily dose – 1200 mg. The drug should be swallowed whole during or immediately after eating, drinking plenty of water. Patients with impaired renal function (creatinine clearance less than 30 mL / min), the dosage may be reduced to 1-2 tablets per day. Reducing the dose, taking into account the individual tolerance, it is necessary in patients with severe hepatic impairment. Treatment can be initiated with small doses in patients with low blood pressure, as well as in individuals at risk due to a possible decrease in blood pressure (patients with severe coronary artery disease or a hemodynamically significant stenosis of the cerebral vessels). In these cases, the dose can be increased only gradually.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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