Trental 400 p / o prolonged-release tablets 400mg, No. 20

- Occlusive disease of peripheral arteries of atherosclerotic or diabetic origin (for example, 'intermittent' claudication, diabetic angiopathy).

- Trophic disorders (for example, trophic ulcers of the legs, gangrene).

- Cerebral circulation disorders (consequences of cerebral atherosclerosis, such as decreased concentration, dizziness, memory impairment), ischemic and post-stroke conditions.

- Circulatory disorders in the retina and choroid of the eye.

- Otosclerosis, degenerative changes against the background of vascular pathology of the inner ear and hearing loss.

The dosage is set by the doctor in accordance with the individual characteristics of the patient.

The usual dose is: one tablet of TrentalЃ 400 two or three times a day. The maximum daily dose is 1200 mg. The drug should be swallowed whole during or immediately after a meal with plenty of water.

In patients with impaired renal function (creatinine clearance below 30 ml / min), the dosage can be reduced to 1-2 tablets per day.

A dose reduction, taking into account individual tolerance, is necessary in patients with severe hepatic impairment.

Treatment can be started in low doses in patients with low blood pressure, as well as in those at risk due to a possible decrease in blood pressure (patients with severe coronary artery disease or hemodynamically significant cerebral stenosis). In these cases, the dose can only be increased gradually.

Active ingredient: pentoxifylline - 400.0 mg.

Excipients: povidone - 10.0 mg, hyetellose - 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.

- Hypersensitivity to pentoxifylline, other methylxanthines or any excipient of the drug.

- Massive bleeding (risk of increased bleeding).

- Extensive retinal hemorrhages (risk of increased bleeding).

- Hemorrhages in the brain.

- Acute myocardial infarction.

- Age up to 18 years old.

- Pregnancy (insufficient data).

- Breastfeeding period (insufficient data).

Carefully :

- Severe heart rhythm disturbances (risk of worsening arrhythmias).

- Arterial hypotension (risk of further lowering blood pressure, see section 'Dosage and Administration').

- Chronic heart failure.

- Peptic ulcer of the stomach and duodenum.

- Renal dysfunction (creatinine clearance below 30 ml / min) (risk of cumulation and increased risk of side effects, see section 'Dosage and Administration').

Severe liver dysfunctions (risk of cumulation and increased risk of side effects, see section 'Dosage and Administration').

- Recently transferred surgical interventions.

- Increased bleeding tendency, for example, as a result of the use of anticoagulants (including indirect anticoagulants [vitamin K antagonists] or in case of disorders in the blood coagulation system (risk of more severe bleeding), see the section 'Interaction with other medicinal products'.

- Simultaneous use with hypoglycemic agents (insulin and hypoglycemic agents and for oral administration), see the section 'Interaction with other medicinal products'.

- Simultaneous use with ciprofloxacin (see the section 'Interaction with other medicinal products').

Active substance :

Pentoxifylline

Dosage form:

prolonged-release film-coated tablets

Composition :

Active ingredient: pentoxifylline - 400.0 mg.

Excipients: povidone - 10.0 mg, hyetellose - 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.

Description:

Oblong biconvex white film-coated tablets. One side of the tablet is engraved with 'ATA'.

Pharmacotherapeutic group:

vasodilating agent.

Pharmacodynamics:

TrentalЃ 400 reduces blood viscosity and improves blood rheological properties (fluidity) due to:

- improving the disturbed deformability of erythrocytes;

- reducing the aggregation of platelets and erythrocytes;

- reducing the concentration of fibrinogen;

- a decrease in the activity of leukocytes and a decrease in the adhesion of leukocytes to the vascular endothelium.

As an active ingredient, TrentalЃ 400 contains a xanthine derivative - pemtoxifylline.

The mechanism of its action is associated with the inhibition of phosphodiesterase and the accumulation of cyclic adenosine monophosphate (cAMP) in the cells of vascular smooth muscles and blood cells.

Providing a weak myotropic vasodilator effect, pemtoxifylline somewhat reduces the total peripheral vascular resistance and slightly dilates the coronary vessels.

Pemtoxifylline has a weak positive inotropic effect on the heart.

Improves microcirculation in areas of impaired blood circulation.

Treatment with TrentalЃ 400 leads to an improvement in the symptoms of cerebrovascular accidents.

In occlusive diseases of peripheral arteries, the use of TrentalЃ 400 leads to an increase in the walking distance, elimination of night cramps in the calf muscles and the disappearance of pain at rest.

Pharmacokinetics:

After oral administration, pentoxifylline is almost completely absorbed.

Pentoxifylline undergoes a 'primary pass' effect through the liver.

The absolute bioavailability of the original substance is 19 ± 13%.

The concentration of the main active metabolite 1- (5-hydroxyxyl) -3,7-dimethylxanthine (metabolite I) in blood plasma is twice the concentration of the original pentoxifylline.

Metabolite I is in a reversible biochemical redox equilibrium with pentoxifylline. Therefore, pentoxifylline and metabolite 1 are considered together as the active unit. As a result, the availability of the active substance is much greater.

Prolonged release of pentoxifylline allows maintaining its constant (peakless) concentration in the blood, which ensures better tolerability of the drug in this dosage form.

The half-life of pentoxifylline after oral administration is 1.6 hours.

Pentoxifylline is completely metabolized and more than 90% is excreted through the kidneys in the form of unconjugated water-soluble metabolites.

Patients with impaired renal function

In patients with impaired renal function, excretion of metabolites is slowed down.

Patients with impaired liver function

In patients with impaired liver function, the half-life of pentoxifylline is lengthened and the absolute bioavailability increases.

Indications for use

- Occlusive disease of peripheral arteries of atherosclerotic or diabetic origin (for example, 'intermittent' claudication, diabetic angiopathy).

- Trophic disorders (for example, trophic ulcers of the legs, gangrene).

- Cerebral circulation disorders (consequences of cerebral atherosclerosis, such as decreased concentration, dizziness, memory impairment), ischemic and post-stroke conditions.

- Circulatory disorders in the retina and choroid of the eye.

- Otosclerosis, degenerative changes against the background of vascular pathology of the inner ear and hearing loss.

Contraindications

- Hypersensitivity to pentoxifylline, other methylxanthines or any excipient of the drug.

- Massive bleeding (risk of increased bleeding).

- Extensive retinal hemorrhages (risk of increased bleeding).

- Hemorrhages in the brain.

- Acute myocardial infarction.

- Age up to 18 years old.

- Pregnancy (insufficient data).

- Breastfeeding period (insufficient data).

Carefully :

- Severe heart rhythm disturbances (risk of worsening arrhythmias).

- Arterial hypotension (risk of further lowering blood pressure, see section 'Dosage and Administration').

- Chronic heart failure.

- Peptic ulcer of the stomach and duodenum.

- Renal dysfunction (creatinine clearance below 30 ml / min) (risk of cumulation and increased risk of side effects, see section 'Dosage and Administration').

Severe liver dysfunctions (risk of cumulation and increased risk of side effects, see section 'Dosage and Administration').

- Recently transferred surgical interventions.

- Increased bleeding tendency, for example, as a result of the use of anticoagulants (including indirect anticoagulants [vitamin K antagonists] or in case of disorders in the blood coagulation system (risk of more severe bleeding), see the section 'Interaction with other medicinal products'.

- Simultaneous use with hypoglycemic agents (insulin and hypoglycemic agents and for oral administration), see the section 'Interaction with other medicinal products'.

- Simultaneous use with ciprofloxacin (see the section 'Interaction with other medicinal products').

Pregnancy and lactation:

Pregnancy

Prsparat TrentalЃ 400 is not recommended for use during pregnancy (as there is insufficient data).

Breastfeeding period

Pentoxifylline passes into breast milk in small amounts. If necessary, the use of the drug should stop breastfeeding (given the lack of experience in use).

Method of administration and dosage

The dosage is set by the doctor in accordance with the individual characteristics of the patient.

The usual dose is: one tablet of TrentalЃ 400 two or three times a day. The maximum daily dose is 1200 mg. The drug should be swallowed whole during or immediately after a meal with plenty of water.

In patients with impaired renal function (creatinine clearance below 30 ml / min), the dosage can be reduced to 1-2 tablets per day.

A dose reduction, taking into account individual tolerance, is necessary in patients with severe hepatic impairment.

Treatment can be started in low doses in patients with low blood pressure, as well as in those at risk due to a possible decrease in blood pressure (patients with severe coronary artery disease or hemodynamically significant cerebral stenosis). In these cases, the dose can only be increased gradually.

Side effect

Below are the adverse reactions that have been observed in clinical trials and with post-marketing use of the drug (frequency unknown).

Nervous system disorders: headache, dizziness, aseptic meningitis, convulsions.

Mental disorders: agitation, sleep disturbances, anxiety.

Heart disorders: tachycardia, arrhythmia, decreased blood pressure, angina pectoris.

Vascular disorders: 'hot flushes' of blood to the skin, bleeding (including bleeding from the vessels of the skin, mucous membranes, stomach, intestines).

Digestive system disorders: xerosgomy (dry mouth), anorexia, intestinal atony, feeling of pressure and fullness in the stomach, nausea, vomiting, diarrhea.

Disturbances from the liver and biliary tract: intrahepatic cholestasis, increased activity of 'hepatic' transaminases, increased activity of alkaline phosphatase.

Blood and lymphatic system disorders: leukopenia, thrombocytopenia, pancytopenia, hypofibrinogenemia.

Violations of the organ of vision: visual impairment, scotoma.

Disorders from the skin and subcutaneous tissues: itching, erythema (redness of the skin), urticaria, increased fragility of the nails, edema.

Immune system disorders: anaphylactic / anaphylactoid reactions, angioedema, anaphylactic shock, bronchospasm.

Overdose:

Overdose symptoms: dizziness, nausea, vomiting of the 'coffee grounds' type, drop in blood pressure, tachycardia, arrhythmia, redness of the skin, loss of consciousness, chills, areflexia, tonic-clonic seizures.

In the event of the occurrence of the above violations, it is necessary to urgently consult a doctor.

Treatment is symptomatic.

When the first signs of an overdose appear (sweating, nausea, cyanosis), immediately stop taking the drug.

If the drug is recently taken, measures should be taken to prevent further absorption of the drug by removing it (gastric lavage) or slowing down absorption (for example, taking activated charcoal).

ќсобое внимание должно быть направлено на поддержание артериального давлени¤ и функции дыхани¤. ѕри судорожных припадках ввод¤т диазепам.

—пецифический антидот неизвестен.

¬заимодействие

— гипотензивными средствами

ѕентоксифиллин повышает риск развити¤ артериальной гипотензии при одновременном применении с гипотензивными средствами (например, ингибиторы ангиотензинпревращающего фермента (јѕ‘)) или другими лекарственными средствами, обладающими потенциальным антигипертензивным эффектом (например, нитраты).

— лекарственными средствами, вли¤ющими на свертывающую систему крови

ѕентоксифиллин может усиливать действие лекарственных средств, вли¤ющих на свертывающую систему крови (пр¤мые и непр¤мые антикоагул¤нты, тромболитики, антибиотики, такие как цефалоспорины).

ѕри совместном применении пентоксифиллина и непр¤мых антикоагул¤н тов (антагонистов витамина  ) в постмаркетинговых исследовани¤х отмечались случаи усилени¤ антикоагул¤нтного действи¤ (риск развити¤ кровотечений). ѕоэтому в начале приема пентоксифиллина или изменении сто дозы рекомендуетс¤ контролировать степень выраженности антикоагул¤нтного действи¤ у пациентов, принимающих данную комбинацию препаратов, например, проводить регул¤рный контроль ћЌќ (международное нормализованное отношение).

— циметидином

?иметидин повышает концентрацию пентоксифиллина в плазме крови (риск возникновени¤ побочных эффектов). — другими ксантинами —овместное назначение с другими ксантинами может приводить к чрезмерному нервному возбуждению.

— гипогликемическими средствами (инсулином и гипогликемическими средствами дл¤ приема внутрь)

vипогликемическое действие инсулина или гипогликемических средств дл¤ приема внутрь может усиливатьс¤ при одновременном применении пентоксифиллина (повышенный риск развити¤ гипогликемии). Ќеобходим строгий контроль состо¤ни¤ таких пациентов, включа¤ регул¤рный гликемический контроль.

— теофиллином

” некоторых пациентов при одновременном применении пентоксифиллина и теофиллина отмечаетс¤ увеличение концентрации теофиллина. ¬ дальнейшем это может приводить к увеличению или усилению побочных действий, св¤занных с теофиллином.

— ципрофлоксацииом

” некоторых пациентов при одновременном применении пентоксифиллина и ципрофлоксацина отмечаетс¤ увеличение концентрации пентоксифиллина в плазме крови. ¬ дальнейшем эго может приводить к увеличению или усилению побочных действий, св¤занных с применением данной комбинации.

ќсобые указани¤ :

Ћечение следует проводить под контролем артериального давлени¤.

” пациентов с сахарным диабетом, принимающих гипогликемические средства, назначение больших доз пентоксифиллина может вызвать выраженную гипогликемию (может потребоватьс¤ коррекци¤ доз гипогликемических средств и проведение гликемического контрол¤).

ѕри назначении препарата “рентал 400 одновременно с антикоагул¤нтами необходим контроль показателей свертывающей системы крови.

” пациентов, недавно перенесших оперативное вмешательство, необходим регул¤рный контроль гемоглобина и гематокрита.

ѕациентам с низким и нестабильным артериальным давлением необходимо уменьшить дозу пентоксифиллина.

” пожилых пациентов может потребоватьс¤ уменьшение дозы пентоксифиллина (повышение биодоступности и снижение скорости выведени¤).

Ѕезопасность и эффективность пентоксифиллина у детей изучены недостаточно.

Smoking can reduce the therapeutic efficacy of the drug.

Impact on the ability to drive a vehicle:

Considering the possible side effects (eg, dizziness), care should be taken when driving and engaging in potentially hazardous activities.

Storage conditions :

Store in a dry place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

List B.

Shelf life :

4 years.

Do not use the drug after the expiry date indicated on the package.

Terms of dispensing from pharmacies:

On prescription