Trental concentrate for the preparation of solution for infusion 20 mg/ml in 5 ml ampoules No. 5


Pharmacological properties

Pentoxifylline (3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydro-1n-purine-2,6-dione) is a methylxanthine derivative.
The mechanism of action of pentoxifylline is due to the inhibition of PDE and the accumulation of cAMP in vascular smooth muscle cells, blood cells, as well as in other tissues and organs. Pentoxifylline inhibits the aggregation of platelets and erythrocytes, increases their elasticity, reduces the increased concentration of fibrinogen in the blood plasma and enhances fibrinolysis, helping to reduce blood viscosity and improve its rheological properties. in addition, pentoxifylline has a weakly expressed myotropic vasodilator effect, slightly reduces blood pressure and has a positive inotropic effect. Due to the use of pentoxifylline, microcirculation and oxygen supply to tissues improves, to a greater extent in the limbs, central nervous system, and moderately in the kidneys. the drug slightly dilates the coronary vessels. After oral administration in a dose of 100 mg, pentoxifylline is almost completely absorbed in the digestive tract. The maximum concentration of pentoxifylline and its main metabolite is achieved 1 hour after administration. The drug has a first pass effect through the liver. The bioavailability of pentoxifylline averages 19% (6–32%). The main pharmacologically active metabolite 1-(5-hydroxyhexyl)-3,7-dimethylxanthine is determined in the blood plasma in a concentration that is 2 times higher than 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 entity. The half-life of pentoxifylline is 1.6 hours. Pentoxifylline is completely metabolized, 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, the excretion of metabolites is slowed down. In patients with impaired liver function, an increase in the half-life of pentoxifylline and an increase in its bioavailability are noted.

Indications

Atherosclerotic encephalopathy, ischemic stroke, dyscirculatory encephalopathy, peripheral circulatory disorders caused by atherosclerosis, diabetes mellitus, inflammation; trophic tissue disorders caused by damage to arteries or veins, microcirculation disorders (postthrombophlebitic syndrome, trophic ulcers, gangrene, frostbite); obliterating endarteritis; angioneuropathy (Raynaud's disease, paresthesia); circulatory disorders of the eye (acute, subacute and chronic circulatory failure in the retina and choroid); dysfunction of the inner ear of a vascular nature, accompanied by hearing loss.

Application

The dose of trental for intravenous infusion is 100–600 mg (in 250–500 ml of lactated ringer solution, infusion solution or 5% glucose solution) 1 or 2 times a day. the duration of the IV infusion is from 60 to 360 minutes, that is, the administration of 100 mg of pentoxifylline should last at least 60 minutes. the infusion can be supplemented with oral administration of trental.

If the patient's condition is severe (constant pain, gangrene, trophic ulcers), it is possible to administer an IV infusion of Trental for 24 hours. The dose is administered at the rate of 0.6 mg/kg/hour. The daily dose for a patient weighing 70 kg is 1000 mg, for a patient weighing 80 kg - 1150 mg. Regardless of body weight, the maximum daily dose is 1200 mg. The volume of the administered solution is calculated individually, taking into account concomitant diseases and the patient’s condition and averages 1.0–1.5 l/day.

The dose of Trental for intravenous injection is 100 mg. Administration is carried out slowly (over at least 5 minutes) 1–2 times a day. The patient must be in a lying position.

Orally, Trental is prescribed in a dose of 2–4 tablets 2–3 times a day after meals, without chewing, with a sufficient amount of liquid.

The maximum total daily dose for parenteral and oral administration is 1.2 g.

Composition and release form

Trental® Enteric film-coated tablets - 1 tablet. pentoxifylline - 100 mg excipients: lactose; starch; talc; colloidal silicon dioxide; magnesium stearate shell: methacrylic acid copolymer; sodium hydroxide; macrogol (polyethylene glycol) 8000, talc; titanium dioxide (E171) in a blister 10 pcs; There are 6 blisters in a cardboard pack. Concentrate for the preparation of solution for infusion - 1 ml pentoxifylline - 20 mg excipients: sodium chloride; water for injection in ampoules of 5 ml; There are 5 ampoules in a cardboard pack. Trental® 400 Extended-release film-coated tablets - 1 tablet. pentoxifylline - 400 mg excipients: povidone (PVP); hyaetellose (hydroxyethylcellulose); talc; magnesium stearate shell composition: hypromellose (hydroxypropyl methylcellulose); benzyl alcohol; titanium dioxide; talc; macrogol (polyethylene glycol) 6000; 10 pcs in blister; There are 2 blisters in a cardboard pack.

Side effects

Nausea, vomiting, heaviness in the epigastric region, diarrhea, headache, dizziness, aseptic meningitis (when taken in high doses), anxiety, sleep disturbances, facial flushing, flushing, tachycardia, angina pectoris, arterial hypotension, skin itching, rash, urticaria, angioedema, extremely rarely - anaphylactic shock. very rarely, mainly when used simultaneously with anticoagulants or antiplatelet agents, bleeding (capillary from the skin and mucous membranes, gastrointestinal). The cause-and-effect relationship of bleeding with taking trental has not been proven. in isolated cases thrombocytopenia was observed.

Overdose

Tablets 100, 400 mg Symptoms: dizziness, retching, drop in blood pressure, tachycardia, arrhythmia, redness of the skin, loss of consciousness, chills, areflexia, tonic-clonic convulsions. Solution for infusion 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 (caffeine-type vomiting grounds). Treatment: symptomatic, special attention should be paid to maintaining blood pressure and respiratory function. Convulsive seizures are relieved by the administration of diazepam. When the first signs of overdose appear (excessive sweating, nausea, cyanosis), immediately stop taking the drug. Provides a lower position for the head and upper body. Monitor the free patency of the airways.

special instructions

The drug is prescribed with caution to patients with severe atherosclerosis of the cerebral and coronary vessels, especially with concomitant hypertension, heart rhythm disturbances, angina attacks, as well as patients with arterial hypotension or labile blood pressure. in these cases, the dose of the drug should be increased gradually, especially when administered parenterally. caution is also required when prescribing the drug to patients with a history of peptic ulcers of the stomach and duodenum; patients who have recently undergone surgery. in these cases, the risk of bleeding is increased, so systematic monitoring of hemoglobin and hematocrit levels is necessary.

Before prescribing Trental, patients with chronic heart failure should achieve circulatory compensation.

For patients with labile or low blood pressure, patients at risk (severe coronary artery disease or severe stenosis of the main vessels of the brain), treatment should begin with the drug in low doses, select doses individually and increase them gradually, taking into account the tolerability of treatment.

In patients with diabetes mellitus receiving insulin therapy or treatment with oral hypoglycemic agents, when using Trental in a high dose, the effect of these drugs on blood glucose levels may be enhanced. In these cases, the dose of insulin or oral hypoglycemic agents should be reduced and regular clinical monitoring should be carried out.

If renal function is impaired (creatinine clearance 30 ml/min), the dose of the drug is selected individually, reducing it by approximately 30–50%. In case of severe liver failure, the dose of Trental should also be reduced depending on individual tolerability of the drug.

Drug interactions

For all dosage forms, Pentoxifylline can enhance the effect of drugs that lower blood pressure (ACE inhibitors, nitrates). Pentoxifylline may enhance the effect of drugs that affect the blood coagulation system (indirect and direct anticoagulants, thrombolytics), antibiotics (including cephalosporins). Cimetidine increases the plasma concentration of pentoxifylline (risk of side effects). Co-administration with other xanthines may lead to excessive nervous stimulation. The hypoglycemic effect of insulin or oral antidiabetic agents may be enhanced when taking pentoxifylline (increased risk of hypoglycemia). Strict monitoring of such patients is necessary. In some patients, concomitant use of pentoxifylline and theophylline may result in increased theophylline levels. This may result in more or worse theophylline-related side effects.

Actual information

Trental (pentoxifylline) is a methylxanthine derivative with powerful hemorheological properties (reduces blood viscosity). The drug belongs to drugs that affect the cardiovascular system and is included in the group of “peripheral vasodilators”.

Pentoxifylline is approved for the treatment of individuals with intermittent claudication due to peripheral arterial occlusive disease. The drug was first marketed in Europe in 1972 and in the United States in 1985. Animal and human studies have demonstrated hemorheological and immunomodulatory properties.

Pharmacological properties

Pharmacokinetics

The drug is easily absorbed from the gastrointestinal tract, but undergoes primary metabolism in the liver. Some of its metabolites are active. The apparent plasma half-life of pentoxifylline is reported to be 0.4–0.8 hours; for metabolites it ranges from 1.0–1.6 hours. Most of the drug dose is excreted in the urine, mainly in the form of metabolites, and less than 4% is excreted in the feces.

Adverse Side Effects

Drug Trental

may cause nausea, gastrointestinal disorders (nausea, vomiting, diarrhea), dizziness, headache, tremor.
These reactions are dose related and as the dose is reduced their severity decreases. Hot flashes, angina, palpitations, cardiac arrhythmias, and hypersensitivity reactions may also occur. Bleeding events have been reported rarely, usually due to risk factors for bleeding. Also, with an overdose of pentoxifylline, fever, weakness, flushing, arterial hypotension, drowsiness, agitation and convulsions are possible. Interactions
Trental

(pentoxifylline) may enhance the effect of antihypertensive drugs.
High parenteral doses of pentoxifylline may enhance the effect of insulin and hypoglycemic drugs in patients with diabetes mellitus. Pentoxifylline should not be administered with ketorolac as there is an increased risk of bleeding and/or prolongation of prothrombin time. There may also be an increased risk of bleeding when using meloxicam. Pentoxifylline may increase serum theophylline levels. Application
Pentoxifylline is prescribed for the treatment of peripheral vascular diseases. Although the drug is often classified as a vasodilator, its main action appears to be to reduce blood viscosity, probably through effects on red blood cells, platelet adhesion and aggregation. It has been reported to increase blood flow to ischemic tissues and improve tissue oxygenation in patients with peripheral vascular disease and to increase oxygen content and has been used for cerebrovascular disorders. Trental

also inhibits the production of the cytokine tumor necrosis factor alpha (TNF α), and this property is being studied in a number of diseases.

Pentoxifylline is administered parenterally at the beginning of therapy (iv infusion, which lasts 60–360 minutes; if the patient’s condition is assessed as severe, then the infusion can be carried out over 24 hours. In some cases, the drug can be administered as an intravenous injection. Dose The drug is calculated individually and depends on many factors. After improvement of the patient's condition, it is recommended to carry out therapy using a tablet dosage form. For the treatment of peripheral vascular diseases, the usual oral dose is 400 mg 3 times / day in a modified release form. The dose can be reduced to 400 mg 2 r / day (as maintenance therapy). The drug should be taken with food to reduce the risk of gastrointestinal disorders. In severe forms of liver or kidney failure, a dose reduction may also be necessary. Beneficial effects may not be obvious until 2–8 week therapy.

Kidney, liver failure

UK manufacturers state that a dose reduction of pentoxifylline may be required in patients with severe liver impairment, while accumulation may occur in patients with severe renal impairment (creatinine clearance (CR) less than 30 ml/min) who receive more than 400 mg 1– 2 rubles/day.

Venous ulcers on the legs

A systematic review of pentoxifylline used in the treatment of venous leg ulcers found that it is an effective adjunct to compression bandaging and may even be effective on its own (Wylie D., 2007).

In the United States of America, this compound is prescribed for the treatment of intermittent claudication. Studies in humans and animals have shown that drug therapy leads to various physiological changes at the cellular level, which may be important in the treatment of various groups of human diseases. Immune modulation (the process of changing one or more parameters) includes increased leukocyte deformability and chemotaxis, decreased endothelial leukocyte adhesion, decreased neutrophil degranulation and superoxide release, decreased production of tumor necrosis factor from monocytes, decreased sensitivity of leukocytes to interleukin-1 and tumor necrosis factor, inhibition T and B lymphocytes and decreased activity of natural killer cells. Hypercoagulable states are improved by decreased platelet aggregation and adhesion, increased plasminogen activator, increased plasmin, antithrombin III, decreased fibrinogen, alpha-2-antiplasmin, alpha-1-antitrypsin, and decreased alpha-2-macroglobulin. Wound healing and connective tissue disruption are a response to increased fibroblast collagenases and decreased production of collagen, fibronectin, and glycosaminoglycans. (Samlaska CP, 1994).

Pentoxifylline is a methylxanthine derivative that is used for microcirculatory disorders as a vasoactive drug. Novel immunomodulatory properties of pentoxifylline have been reported, including downregulation of the synthesis of tumor necrosis factor-α and other inflammatory cytokines. Research has shown that pentoxifylline may be effective for a wide range of skin conditions (Maakmak SK, 2012).

Refractory or recurrent leg ulcers usually indicate the presence of impaired venous or arterial microcirculation (or both). According to the current hypothesis, local oxygen and nutrient deficiency occurs because the capillary lumens narrow and become permeable to fibrinogen and proteins due to activated leukocytes and inadequate fibrinolysis. The result is the deposition of a relatively impermeable perivascular fibrin sheath that prevents adequate delivery of oxygen and nutrients. Therefore, therapy should be aimed at eliminating these deficiencies and improving wound healing. Pentoxifylline ( Trental

), used in combination with local wound treatment and appropriate antibacterial therapy, has significantly improved the healing of refractory leg ulcers. Pentoxifylline can change the abnormal function of white blood cells, red blood cells, platelets, and also reduce blood viscosity and vascular permeability. The mechanisms of action of pentoxifylline are described in the light of current hypotheses regarding the development of leg ulcers. Nine cases are also discussed in which pentoxifylline, when added to previously unsuccessful local wound care, improved or cured refractory ulcers (Brenman SA, 1991).

Venous leg ulcers are a common, recurrent and disabling condition. The mainstay of treatment is the use of firm compression bandages or stockings to support the veins in the leg. Some leg ulcers take many months or years to heal, and treatment is aimed at preventing infection and promoting healing. Trental

in tablet form is prescribed to improve blood circulation.
A review of studies shows that pentoxifylline, 400 mg tablet taken three times a day, increases the likelihood of recovery. Trental
is an effective adjunct to compression bandages for the treatment of venous ulcers. In the absence of compression, pentoxifylline also appears effective for the treatment of venous ulcers. The main side effects were gastrointestinal disorders (nausea, indigestion and diarrhea).

Leg ulcers are sores on the lower limb that have not healed within four to six weeks. The condition is thought to affect about 1% of the population at some point in life and occurs more often in women than men. About 50–70% of leg ulcers are of venous origin.

The association between calf muscle deficiency and ulceration has long been known. Two hypotheses have been put forward to explain the microcirculatory changes observed in venous ulceration. A 1982 review suggested that venous hypertension increases capillary permeability, resulting in the formation of an impermeable pericapillary fibrin cuff causing local tissue ischemia. However, Coleridge Smith, 1988, argued that the fibrin cuff is secondary to capillary occlusion by white cell plugs, which creates distal ischemia. Trapped white cells release agents that damage the endothelium, increasing capillary permeability and allowing the formation of a fibrin cuff. More recently, Coleridge Smith suggested that it is the infiltration of the skin with protein products alone that promotes tissue destruction.

Another Cochrane review found that compression therapy increased the proportion of healed venous ulcers (O'Meara, 2012). However, despite the use of compression, a proportion of venous ulcers remain non-healing, and therapy adjunctive to compression may be beneficial. Trental

as an adjunct to compression therapy for venous ulcers has been the subject of research with conflicting results (Colgan, 1990; Dale, 1999).
As standard therapy, Trental
was also compared with placebo without compression (Weitgasser, 1983; Jull A.V. et al., 2012).
Conclusion
Pentoxifylline was first registered (in Germany) about 50 years ago. Then its main effect was to dilate blood vessels. Later, no hemorheological effect, in particular on the deformability of erythrocytes, was detected. Regardless of its pharmacological effects, clinical effectiveness in peripheral and cerebral artery diseases is well established. After some period, I became interested in the effect of the drug Trental

on leukocytes.
Both rheological and biochemical changes have been reported. The properties of this drug are being studied, and its therapeutic potential is also being studied, so there is a possibility that in the near future the use of Trental
will expand and go beyond angiology.

Product description certified by the manufacturer Hinoin

.
Verified by
Likar Turumkulova Irina

Trental concentrate for the preparation of solution for infusion 20 mg/ml in 5 ml ampoules No. 5

Name

Trental conc. d/prig.r-ra d/inf. 20 mg/ml in amp. 5 ml in pack No. 5

Description

Almost transparent colorless solution.

Main active ingredient

Pentoxifylline

Release form

Concentrate

Dosage

20mg/ml

Pharmacodynamics

Trental® improves the rheological properties of blood (fluidity) by affecting the pathologically altered deformability of red blood cells, inhibiting platelet aggregation and reducing high blood viscosity. Trental® improves microcirculation in areas of poor circulation. As an active ingredient, Trental® contains a xanthine derivative - pentoxifylline. The mechanism of its action is associated with the inhibition of phosphodiesterase and the accumulation of cAMP in the cells of vascular smooth muscles and blood cells. Providing a weak myotropic vasodilating effect, pentoxifylline slightly reduces total peripheral vascular resistance and slightly dilates the coronary vessels. Treatment with Trental® leads to an improvement in the symptoms of cerebrovascular accidents. The success of treatment for occlusive lesions of the peripheral arteries (for example, intermittent claudication) is manifested in lengthening the walking distance, eliminating night cramps in the calf muscles and the disappearance of pain at rest.

Pharmacokinetics

Pentoxifylline does not bind to plasma proteins. Pentoxifylline is extensively metabolized in red blood cells and the liver. Among the most well-known metabolites, metabolite-1 (M-I; hydroxypentoxifylline) is formed due to cleavage, and metabolite-4 (M-IV) and metabolite-5 (M-V; carboxypentoxifylline) are formed due to oxidation of the main substance. M-I has the same pharmacological activity as pentoxifylline. Excreted primarily through the kidneys (95% after 24 hours) and 3-4% with feces and in the form of metabolites. The half-life is approximately one hour. Pentoxifylline has a large volume of distribution (168 L after a 30-minute infusion of 200 mg) and a high clearance of approximately 4500-5100 ml/min. Possible accumulation of metabolites in patients with severe renal failure. In older people, elimination occurs more slowly than in young people. In patients with severely impaired liver function, the half-life of pentoxifylline and bioavailability are increased.

Indications for use

Occlusive disease of peripheral arteries of atherosclerotic or diabetic origin (for example, with “intermittent claudication” or rest pain). Trophic disorders (for example, leg ulcers or gangrene). Cerebrovascular disease of atherosclerotic origin. Circulatory disorders in the retina and choroid of the eye and ears with degenerative vascular changes, decreased vision and hearing.

Directions for use and doses

Dose The dose and method of administration are determined by the severity of circulatory disorders, as well as on the basis of individual tolerability of the drug. The dosage is set by the doctor in accordance with the individual characteristics of the patient. When using a parenteral form of release, the infusion time should be at least 60 minutes per 100 mg of pentoxifylline. Peripheral circulatory disorders of atherosclerotic origin stage II (“intermittent” claudication) and circulatory disorders in the structures of the eye; Initial therapy or maintenance therapy for oral administration of the drug An infusion of 100 to 600 mg of pentoxifylline once or twice daily is recommended. An infusion of pentoxifylline in a suitable infusion solution is recommended. Depending on concomitant diseases (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. When low-dose infusion is combined with oral administration of the drug, the recommended daily dose is 1200 mg of pentoxifylline (intravenously and orally). For further treatment, therapy can be carried out only by taking pentoxifylline orally. Peripheral circulatory disorders of atherosclerotic origin stages III and IV The recommended daily dose is 1200 mg of pentoxifylline as a continuous infusion in a suitable infusion solution over 24 hours or as an infusion of 600 mg twice a day for a period of at least 6 hours. An infusion of pentoxifylline in a suitable infusion solution is recommended. Depending on concomitant diseases (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. For further treatment, therapy can be carried out only by taking pentoxifylline orally. Special cases In patients with renal failure (creatinine clearance below 30 ml/min), the dose should be adjusted to 50-70% of the standard dose, depending on the patient’s individual tolerability of the drug. A dose reduction based on individual tolerance is necessary in patients with severe liver dysfunction. Treatment can be started in small doses in patients with low blood pressure, as well as in those at risk due to a possible decrease in pressure (patients with severe coronary artery disease or with hemodynamically significant stenoses of cerebral vessels). In these cases, the dose can only be increased gradually. In old age, it is recommended to reduce the dosage and control blood pressure, especially when used in conjunction with antihypertensive and vasodilating agents. Children There is no data on the use of the drug in children. Pregnancy There is not enough experience regarding the use of the drug during pregnancy. Therefore, it is recommended not to use Trental® during pregnancy. Lactation Pentoxifylline passes into breast milk in small quantities. Since there is insufficient experience with the use of Trental® in breastfeeding women, the physician should carefully weigh the possible risks and benefits before prescribing the drug.

Use during pregnancy and lactation

Insufficient experience has been gained regarding the use of the drug during pregnancy. Therefore, it is recommended not to use Trental® during pregnancy. Lactation Pentoxifylline passes into breast milk in small quantities. Since there is insufficient experience with the use of Trental® in breastfeeding women, the physician should carefully weigh the possible risks and benefits before prescribing the drug.

Precautionary measures

Use Pentoxifylline with caution in the following situations: Diabetes: Due to the increased risk of bleeding, ophthalmic monitoring is necessary. Severe coronary or cerebral artery disease: due to an increased risk of low blood pressure. In patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases: Pentoxifylline should be used only after a careful benefit-risk assessment. Due to the risk of aplastic anemia during therapy with pentoxifylline, regular monitoring of blood counts should be performed. When the first signs of an anaphylactic/anaphylactoid reaction appear, the drug infusion should be stopped. Patients should be warned about this. Particularly careful monitoring is necessary: ​​in patients with severe arrhythmias; in patients with acute myocardial infarction; in patients with hypotension; in patients with impaired renal function (creatinine clearance below 30 ml/min); in patients with severe liver dysfunction; in patients with an increased tendency to bleed, including as a result of the use of anticoagulants or with disorders in the blood coagulation system (risk of developing more severe bleeding); in patients with an increased risk of low blood pressure (patients with severe coronary heart disease and significant stenosis of blood vessels); in patients simultaneously receiving pentoxifylline and anti-vitamin K; in patients simultaneously receiving pentoxifylline and antidiabetic agents; in patients simultaneously receiving pentoxifylline and ciprofloxacin. Treatment should be carried out under blood pressure control. In patients with diabetes mellitus taking hypoglycemic agents, the administration of large doses can cause severe hypoglycemia (dose adjustment is required). When prescribed simultaneously with anticoagulants, it is necessary to carefully monitor the blood coagulation system. In patients who have recently undergone surgery, systematic monitoring of hemoglobin and hematocrit levels is necessary. The administered dose should be reduced in patients with low and unstable blood pressure. In older adults, dose reduction may be necessary (increased bioavailability and decreased rate of elimination). The safety and effectiveness of pentoxifylline in children have not been sufficiently studied. Smoking may reduce the therapeutic effectiveness of the drug. The compatibility of the pentoxifylline solution with the infusion solution should be checked on a case-by-case basis. When performing intravenous infusions, the patient should be in a supine position. The drug contains sodium in the amount of 12.4 mg - 15.1 mg (0.54 - 0.66 mmol) per ampoule. This must be taken into account in patients on a sodium-controlled diet.

Interaction with other drugs

Pentoxifylline can enhance the effect of drugs that lower blood pressure (ACE inhibitors, nitrates). Pentoxifylline may enhance the effect of drugs that affect the blood coagulation system (indirect and direct anticoagulants, thrombolytics), antibiotics (including cephalosporins). Cimetidine increases the plasma concentration of pentoxifylline (risk of side effects). Co-administration with other xanthines may lead to excessive nervous stimulation. The hypoglycemic effect of insulin or oral antidiabetic agents may be enhanced when taking pentoxifylline (increased risk of hypoglycemia). Strict monitoring of such patients is necessary. In some patients, concomitant use of pentoxifylline and theophylline may result in increased theophylline levels. This may result in more or worse theophylline-related side effects. Coadministration with ciprofloxacin may increase serum concentrations of pentoxifylline in some patients. Thus, adverse reactions associated with co-administration of the drug may increase and intensify.

Contraindications

hypersensitivity to pentoxifylline, other methylxanthines or to any of the components of the drug; acute myocardial infarction; massive bleeding; extensive hemorrhages in the retina; ulcers in the stomach and/or intestines, hemorrhagic diathesis.

Compound

1 ml contains: active ingredient: pentoxifylline – 20 mg; excipients: sodium chloride – 7 mg, water for injection – up to 1 ml.

Overdose

Symptoms of overdose: 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 is symptomatic: special attention should be paid to maintaining blood pressure and respiratory function. Convulsive seizures are treated with diazepam. When the first signs of overdose appear, immediately stop administering the drug. Provides a lower position for the head and upper body.

Side effect

In cases where Trental® is used in large doses or at a high rate of infusion, the following side effects may sometimes occur: from the nervous system: headache, dizziness, anxiety, sleep disturbances, convulsions, aseptic meningitis, tremor, paresthesia, intracranial hemorrhage; on the part of the skin and subcutaneous fat: hyperemia of the facial skin, itching, erythema (redness of the skin), “flushes” of blood to the skin of the face and upper chest, edema, increased brittleness of nails, epidermal necrolysis, Stevens-Johnson syndrome, sweating ; from the digestive system: gastrointestinal disorders, epigastric discomfort, bloating, nausea, vomiting, diarrhea, xerostomia, anorexia, intestinal atony; from the cardiovascular system: tachycardia, arrhythmia, cardialgia, progression of angina pectoris, decreased blood pressure; from the blood and lymphatic system: thrombocytopenia, bleeding from blood vessels of the skin, mucous membranes, stomach, intestines, aplastic anemia (pancytopenia); from the organ of vision: visual impairment, conjunctivitis, retinal hemorrhage, retinal detachment; allergic reactions: anaphylactic or anaphylactoid reactions, such as bronchospasm, itching, skin flushing, urticaria, angioedema, anaphylactic shock; from the kidneys and urinary tract: bleeding from the genitourinary system; from the liver and biliary tract: intrahepatic cholestasis and increased activity of “liver” transaminases; mental disorders: agitation, sleep disorders; laboratory and instrumental studies: increased concentration of alkaline phosphatase, increased blood pressure; general disorders: fever, peripheral edema. If side effects occur, you must stop taking the drug. If the listed adverse reactions occur, as well as reactions not listed in the instructions for use, you should consult a doctor.

Storage conditions

Store in a place protected from light at temperatures from 8°C to 25°C. Keep out of the reach of children!

Note!

Description of the drug Trental solution d/in. 20mg/ml amp. 5ml No. 5 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

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