Latren solution for infusion 0.5 mg/ml bottle 200 ml

Instructions Latren solution for infusion 0.5 mg/ml bottle 200 ml

Composition

active ingredient: 1 ml of solution contains 0.5 mg of pentoxifylline;

excipients: sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate solution, water for injections.

Dosage form

Solution for infusion.

Main physicochemical properties: colorless or slightly yellowish transparent solution.

Pharmacotherapeutic group

Peripheral vasodilators. Purine derivatives.

ATX code C04A D03.

Pharmacological properties

Pharmacodynamics

Pentoxifylline is a methylxanthine derivative. The mechanism of action of pentoxifylline is associated with the inhibition of phosphodiesterase and the accumulation of 3,5-AMP in vascular smooth muscle cells, blood cells, as well as in other tissues and organs. Pentoxifylline inhibits platelet and erythrocyte aggregation, increases their flexibility, reduces the increased concentration of fibrinogen in blood plasma and enhances fibrinolysis, which reduces blood viscosity and improves its rheological properties. In addition, pentoxifylline causes a weak myotropic vasodilator effect, slightly reduces total peripheral vascular resistance and has a positive inotropic effect. As a result of the use of pentoxifylline, microcirculation and tissue oxygen supply improve, most of all in the extremities, CNS, moderately in the kidneys. The drug slightly dilates coronary vessels.

Pharmacokinetics

The main pharmacologically active metabolite 1-(5-hydroxyhexyl)-3,7-dimethylxanthine (metabolite I) is detected in blood plasma at a concentration exceeding that in
2 times the concentration of the unchanged substance and is in a state of reverse biochemical equilibrium with it. In this regard, pentoxifylline and its metabolite should be considered as an active whole. The half-life of pentoxifylline is 1.6 hours.

Pentoxifylline is completely metabolized, more than 90% is excreted by the kidneys in the form of unconjugated water-soluble polar metabolites. Less than 4% of the administered dose is excreted in the feces. In patients with severe renal impairment, excretion of metabolites is slowed down. In patients with impaired liver function, an increase in the half-life of pentoxifylline has been noted.

Indication

Atherosclerotic encephalopathy; ischemic cerebral stroke; dyscirculatory encephalopathy; peripheral circulatory disorders caused by atherosclerosis, diabetes mellitus (including diabetic angiopathy), inflammation; trophic disorders in tissues associated with damage to veins or impaired microcirculation (postthrombophlebitic syndrome, trophic ulcers, gangrene, frostbite); obliterating endarteritis; angioneuropathy (Raynaud's disease); circulatory disorders of the eye (acute, subacute, chronic circulatory insufficiency in the retina and choroid of the eye); disorders of the function of the inner ear of vascular genesis, which are accompanied by hearing loss.

Contraindication

Latren® is contraindicated:

patients with hypersensitivity to pentoxifylline, other methylxanthines or any of the excipients of Latren®;

patients with massive bleeding (risk of increased bleeding);

patients with extensive retinal hemorrhage, with cerebral hemorrhage (risk of increased bleeding). If retinal hemorrhage occurs during treatment with pentoxifylline, the drug should be discontinued immediately;

patients in the acute period of myocardial infarction;

patients with gastric and/or intestinal ulcers;

patients with hemorrhagic diathesis.

Interaction with other medicinal products and other types of interactions

The blood sugar-lowering effect of insulin or oral antidiabetic agents may be potentiated. Therefore, patients receiving drug treatment for diabetes should be closely monitored.

In the post-marketing period, cases of increased anticoagulant activity have been reported in patients who were simultaneously treated with pentoxifylline and vitamin K antagonists. When prescribing or changing the dosage of pentoxifylline, it is recommended to monitor anticoagulant activity in this group of patients.

Latren® may enhance the hypotensive effect of antihypertensive agents and other drugs that may cause a decrease in blood pressure.

Concomitant use of pentoxifylline and theophylline may lead to increased blood levels of theophylline in some patients. Therefore, an increase in the frequency and severity of adverse reactions to theophylline is possible.

In some patients, concomitant use with ciprofloxacin may lead to an increase in the serum concentration of pentoxifylline. As a result, the frequency and severity of adverse reactions associated with the simultaneous use of the drugs may increase.

Concomitant use with cimetidine may increase the concentration of pentoxifylline and metabolite I in blood plasma.

Application features

At the first signs of an anaphylactic/anaphylactoid reaction during treatment with Latren®, the infusion should be stopped immediately and a doctor should be consulted.

When using Latren® in patients with chronic heart failure, the phase of circulatory compensation should first be achieved.

In patients with diabetes mellitus treated with insulin or oral antidiabetic agents, the effect of these drugs on blood sugar levels may be increased when using high doses of Latren® (see section "Interaction with other medicinal products and other types of interactions"). In these cases, the dose of insulin or oral antidiabetic agents should be reduced and the patient should be monitored closely.

Patients with systemic lupus erythematosus (SLE) or other connective tissue diseases should be prescribed pentoxifylline only after a thorough analysis of the possible risks and benefits.

Since there is a risk of developing aplastic anemia during treatment with pentoxifylline, regular monitoring of complete blood counts is required.

In patients with renal insufficiency (creatinine clearance less than 30 ml/min) or severe liver dysfunction, the elimination of pentoxifylline may be delayed. Appropriate monitoring is required.

Particularly careful observation is necessary for:

patients with severe cardiac arrhythmias;

patients with arterial hypotension;

patients with severe atherosclerosis of cerebral and coronary vessels, especially with concomitant arterial hypertension and heart rhythm disturbances. These patients may experience angina attacks, arrhythmias and arterial hypertension when taking the drug;

patients with renal insufficiency (creatinine clearance below 30 ml/min);

patients with severe hepatic insufficiency;

patients with a high tendency to bleed, for example due to anticoagulant treatment or blood clotting disorders. For bleeding, see section "Contraindications";

patients who have recently undergone surgical treatment (increased risk of bleeding, which requires systematic monitoring of hemoglobin and hematocrit levels);

patients for whom a decrease in blood pressure is a high risk (for example, patients with severe ischemic heart disease or stenosis of the vessels supplying blood to the brain);

patients receiving concomitant treatment with pentoxifylline and vitamin K antagonists or platelet aggregation inhibitors (see section "Interaction with other medicinal products and other types of interactions");

patients receiving concomitant treatment with pentoxifylline and antidiabetic agents (see section “Interaction with other medicinal products and other types of interactions”);

patients receiving concomitant treatment with pentoxifylline and ciprofloxacin (see section “Interaction with other medicinal products and other types of interactions”).

patients receiving concomitant treatment with pentoxifylline and theophylline (see section "Interaction with other medicinal products and other types of interactions").

Use during pregnancy or breastfeeding

Pregnancy

There is insufficient experience with the use of the drug in pregnant women. Therefore, the use of Latren® during pregnancy is not recommended.

Breast-feeding

Pentoxifylline passes into breast milk in small amounts. If treatment with Latren® is prescribed, breastfeeding should be discontinued.

Ability to influence reaction speed when driving vehicles or other mechanisms

Since the drug is used in a hospital setting, there is no data on such effects.

Method of administration and doses

Intravenous infusions are the most effective and well-tolerated forms of parenteral administration of the drug. The dosage regimen is determined by the doctor and depends on the severity of circulatory disorders, body weight and tolerability of the treatment. Infusion can be carried out only if the solution is clear.

The following treatment regimens are recommended for adults: 1. Intravenous infusion of 100-600 mg of pentoxifylline 1-2 times a day. The duration of intravenous drip infusion is 60-360 minutes, i.e. the administration of 100 mg of pentoxifylline should last at least 60 minutes.

In severe patient condition (especially in case of persistent pain, gangrene or trophic ulcers), pentoxifylline infusion may be performed for 24 hours. With this administration regimen, the dose should be determined at the rate of 0.6 mg/kg/hour. The daily dose calculated in this way for a patient weighing 70 kg is 1000 mg, for a patient weighing 80 kg – 1150 mg. Regardless of the patient’s body weight, the maximum daily dose is 1200 mg. The volume of the infusion solution is calculated individually, taking into account concomitant diseases and the patient’s condition, and is on average 1-1.5 l per day.

The duration of parenteral treatment is determined by the treating physician.

Children.

There is no experience with the use of the drug in children.

Overdose

Initial symptoms of acute overdose with pentoxifylline are nausea, dizziness or decreased blood pressure. In addition, symptoms such as fever, agitation, hot flashes, tachycardia, loss of consciousness, areflexia, arrhythmia, tonic-clonic seizures and vomiting in the form of "coffee grounds" as a sign of gastrointestinal bleeding may develop.

Overdose treatment

In order to treat acute overdose and prevent complications, general and specific intensive medical observation and therapeutic measures are necessary.

Adverse reactions

The following are adverse reactions that have occurred during clinical trials and post-marketing experience. The frequency of occurrence is unknown.

Expiration date

2 years.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25 °C.

Do not freeze.

Incompatibility

The drug should not be mixed with other medicines in the same container.

Packaging

200 ml in glass bottles; 200 ml in polymer bottles.

Vacation category

According to the recipe.

Producer

LLC "Yuria-Pharm".

Location of the manufacturer and its business address

Ukraine, 18030, Cherkasy region, Cherkasy city, Kobzarska st., 108. Tel. (044) 281-01-01.