Trental concentrate for solution for infusion ampoules 5 ml 5 pcs
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Active ingredients
Pentoxifylline
Release form
Concentrate
Composition
1 ml concentrate for solution for infusion contains pentoxifylline 20 mg. Excipients: sodium chloride - 7 mg, water d / and - up to 1 ml.
Pharmacological effect
Vasodilator, improves microcirculation, normalizes the rheological properties of blood
Pharmacokinetics
Pentoxifylline is extensively metabolized in red blood cells and the liver. Among the most well-known metabolites, metabolite-1 (M-1; hydroxy-pentoxifylline) is formed due to cleavage, and metabolite-4 (M-IV) and metabolite-5 (M-V; carboxy-pentoxifylline) - due to oxidation of the main substance. M-l has the same pharmacological activity as pentoxifylline. More than 90% of the taken dose of pentoxifylline is eliminated through the kidneys and 3-4% with feces. T1 / 2 of pentoxifylline after i.v. injection of 100 mg was approximately 1.1 hours. In patients with severely impaired liver function, pentoxifylline T1 / 2 increases. Pentoxifylline has a large volume of distribution (168 L after a 30 min infusion of 200 mg) and a high clearance of approximately 4500–5100 ml / min. Pentoxifylline and its metabolites do not bind to plasma proteins. In severe impaired renal function, excretion of metabolites is slow.
Indications
Peripheral circulation disorders of atherosclerotic genesis (for example, intermittent claudication, diabetic angiopathy), trophic disorders (for example, trophic ulcer of the leg, gangrene); frostbite, postthrombotic syndrome, etc.; cerebral circulation disorders (consequences of cerebral atherosclerosis, such as impaired concentration, dizziness, memory impairment), ischemic and post-stroke conditions, circulatory disorders in the retina and choroid, otosclerosis, degenerative changes on the background pathology of the vessels of the inner ear and hearing loss.
Contraindications
Hypersensitivity to pentoxifylline, other methylxanthines or to any of the components of the drug, massive bleeding, extensive hemorrhages in the retina, hemorrhages in the brain, acute myocardial infarction, severe arrhythmias, severe atherosclerotic lesions of the coronary or brain arteries, uncontrolled arteriosa infant feedingage up to 18 years old. With caution: hypotension (risk of blood pressure reduction), chronic heart failure, impaired kidney function (Cl creatinine below 30 ml / min) (risk of cumulation and increased risk of side effects), severe abnormalities of liver function (risk of cumulation and increased risk of side effects); increased tendency to bleeding, incl. as a result of the use of anticoagulants or in case of disturbances in the blood coagulation system (risk of more severe bleeding), after recent surgery
Precautionary measures
With care: liver failure. Patients with severe impaired renal function require careful medical supervision. Older people may need to reduce the dose (increased bioavailability and reduced rate of excretion)
Use during pregnancy and lactation
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Dosage and administration
The dosage is determined by the doctor in accordance with the individual characteristics of the patient. B / B, drip, dose and method of administration is determined by the severity of circulatory disorders, as well as on the basis of individual tolerance of the drug. The usual dose is two intravenous infusions per day (morning and afternoon) of which contains 200 mg of pentoxifylline (2 amp. 5 ml) or 300 mg of pentoxifylline (3 amp. 5 ml) in 250 ml or 500 ml of 0.9% sodium chloride solution or Ringer's solution. Compatibility with other infusion solutions should be tested separately; only clear solutions can be used. Pentoxifylline (100 mg) should be administered for at least 60 minutes. Depending on comorbidities (heart failure), it may be necessary to reduce the injected volumes. In such cases, it is recommended to use a special infuser for controlled infusion. After the daily infusion, an additional 2 pills can be administered. Trentala 400 mg. If 2 infusions are separated by a longer interval, then 1 tab. Trental 400 mg from the two prescribed supplements may be taken earlier (at about noon). If, due to clinical conditions, intravenous infusion is possible only once a day, 3 pills can be added after it.Trentala 400 mg (at noon - 2 tab. And in the evening - 1 tab.). A long-term intravenous infusion of Trental — for 24 hours is indicated in more severe cases, especially in patients with severe pain at rest, with gangrene or trophic ulcers (stage III – IV according to Fontaine). The dose of Trental administered parenterally for 24 hours, as a rule, it should not exceed 1200 mg of pentoxifylline, while the individual dose can be calculated by the formula: 0.6 mg of pentoxifylline per kg of mass per hour. The daily dose calculated in this way will be 1000 mg of pentoxifylline - for a patient weighing 70 kg and 1150 mg of pentoxifylline - for a patient weighing 80 kg. In patients with renal insufficiency (Cl creatinine <30 ml / min), it is necessary to reduce the dosage by 30–50%, which depends on the individual tolerance of the drug to patients. For all dosage forms, the dosage is determined by the doctor in accordance with the individual characteristics of the patient. Dose reduction, taking into account individual tolerance, is necessary in patients with severely impaired liver function. Treatment can be started in small doses in patients with low blood pressure, as well as in people at risk due to a possible reduction in blood pressure (patients with severe IHD or with hemodynamically significant stenoses of cerebral vessels). In these cases, the dose can be increased only gradually.
Side effects
In cases where Trental is used in large doses or at high infusion rates, the following side effects can sometimes occur: From the nervous system: headache, dizziness, anxiety, sleep disorders, convulsions. From the skin and subcutaneous fat: hyperemia facial skin, flushing of the face and upper chest, edema, increased brittle nails. On the digestive system: xerostomia, anorexia, intestinal atony. On the side of the cardiovascular system: tachycardia, arrhythmia, cardi Algia, progression of stenocardia, decrease in blood pressure. From the side of the hemostasis system and blood formation organs: leukopenia, thrombocytopenia; pancytopenia, bleeding from skin vessels, mucous membranes, stomach, intestines, hypofibrinogenemia. For the senses: visual disturbances, scotoma. Allergic reactions: itching, skin hyperemia, urticaria, angioedema, anaphylactic shock. Very rare cases of aseptic meningitis, intrahepatic cholestasis and increased activity of "hepatic" transaminases, alkaline phosphatase
Overdose
Symptoms: weakness, sweating, nausea, cyanosis, dizziness, decreased blood pressure, tachycardia, fainting, drowsiness or agitation, arrhythmia, hyperthermia, areflexia, loss of consciousness, tonic-clonic convulsions, signs of gastrointestinal bleeding (vomiting like coffee grounds). Treatment: symptomatic, special attention should be directed to maintaining blood pressure and respiratory function. Convulsive seizures are relieved by administering diazepam. When the first signs of an overdose appear (excessive sweating, nausea, cyanosis), the drug is immediately stopped. Provide a lower position of the head and upper torso. Monitor the free airway.
Interaction with other drugs
Pentoxifylline is able to enhance the effect of drugs that reduce blood pressure (ACE inhibitors, nitrates). Pentoxifylline may increase the effect of drugs affecting the blood coagulation system (indirect and direct anticoagulants, thrombolytics), antibiotics (including cephalosporins). Cimetidine increases concentration. plasma (risk of side effects). Co-administration with other xanthines can lead to excessive nervous excitement. The sugar-reducing effect of insulin or oral antidiabetic agents can be strengthened while taking pentoxifylline (increased risk of hypoglycaemia). Strict monitoring of such patients is necessary. In some patients, simultaneous administration of pentoxifylline and theophylline may lead to an increase in theophylline level. This may lead to an increase or increase in side effects associated with theophylline.
special instructions
Treatment should be under the control of AD. In diabetic patients taking hypoglycemic agents, the appointment of large doses can cause severe hypoglycemia (dose adjustment is required). When prescribed simultaneously with anticoagulants, you should carefully monitor the blood coagulation parameters. In patients who have recently undergone surgery. , systematic monitoring of hemoglobin and hematocrit levels is necessary. The dose administered should be reduced in patients with low and unstable blood pressure. In elderly people It may be necessary to reduce the dose (increased bioavailability and reduced speedexcretion). The safety and efficacy of pentoxifylline in children have not been sufficiently studied. Smoking may reduce the therapeutic efficacy of the drug. The compatibility of pentoxifylline solution with an infusion solution should be checked in each particular case.