Pentoksifillin-Nan

General characteristics. Structure:

Active ingredient: 100 mg of a pentoksifillin.

Excipients: lactose monohydrate, potato starch, stearic acid, acryle - from (including copolymer of methacrylic acid with ethyl acrylate, talc, triethyl citrate, sodium lauryl sulfate, sodium a carbonate, silicon dioxide colloid anhydrous, titanium E 171 dioxide).

The medicine improving microblood circulation due to reduction of its viscosity, a vasoprotective.

Pharmacological properties:

Pharmacodynamics. Improves rheological properties of blood (flowability) and reduces its viscosity. Has antitrombotichesky effect. Reduces the general peripheric resistance and expands coronary vessels. Treatment leads to improvement of symptomatology of disturbances of cerebral circulation. Favorable therapeutic results are noted in case of use of a pentoksifillin at vascular pathology of eyes and an inner ear.

Improves microcirculation in zones of the broken blood supply. At the "alternating" lameness leads to lengthening of a distance of walking, elimination of night spasms of gastrocnemius muscles and pains at rest. Renders a favorable effect at trophic disturbances of fabrics (including at trophic ulcers).

Indications to use:

- Disturbances of peripheric circulation of atherosclerotic and diabetic genesis (for example, the alternating lameness, a diabetic angiopatiya).

- Trophic disturbances (for example, trophic ulcers of shins, gangrene).

- A symptomatic treatment at cerebral ischemic diseases (except for Alzheimer's disease and other types of dementia).

- Disturbances of blood circulation in a retina and a choroid of an eye, an otosclerosis, degenerative changes against the background of pathology of vessels of an inner ear and decrease in hearing.

Route of administration and doses:

Inside. The tablets covered with a kishechnorastvorimy cover are swallowed entirely, washing down with a large amount of water, in time or immediately after food. The daily dose is divided into 3 receptions, on 200 mg by 2-3 times a day, the maximum single dose - 400 mg, daily - 1200 mg.

Dosing in special cases. Patients with damage of kidneys: at the chronic renal failure (CRF) with the clearance of creatinine (CC) less than 30 ml/min. the daily dose makes 100-200 mg.

Patients with damage of a liver: the dose decline (taking into account individual portability) is necessary at patients with a heavy liver failure.

Treatment with small doses is begun at patients with arterial hypotension, patients with risk of a lowering of arterial pressure (ABP) (a heavy ischemic heart disease, hemodynamically significant stenosis of vessels of a brain) with the subsequent gradual increase in a dose.

Elderly people: the dose decline of a pentoksifillin can be required (owing to increase in bioavailability and reduction in the rate of removal).

Children and teenagers: there is no experience of use.

Features of use:

Treatment should be carried out under control of arterial pressure.

At the patients with a diabetes mellitus accepting hypoglycemic drugs, appointment in high doses can cause the expressed hypoglycemia (dose adjustment is required).

At appointment along with anticoagulants it is necessary to watch indicators of coagulant system of blood carefully. With care it is necessary to apply пентоксифиллин at patients with the broken coagulability of blood (the increased risk of bleeding).

At the patients who transferred recently an operative measure systematic control of hemoglobin and a hematocrit is necessary.

The entered dose has to be reduced at patients with low and unstable arterial pressure.

At elderly people reduction of a dose (increase in bioavailability and reduction in the rate of removal) can be required.

Safety and efficiency of a pentoksifillin at children and teenagers are studied insufficiently.

Smoking can reduce a therapeutic effectiveness of drug.

With extra care it is necessary to apply пентоксифиллин to patients with  an impaired renal function and heavy abnormal liver functions (reduction of a dose of a pentoksifillin is necessary).

It is necessary to be careful at purpose of a pentoksifillin to patients with the expressed arterial hypotension, with tendency to orthostatic hypotension, at the expressed coronarosclerosis and cerebral atherosclerosis with arterial hypertension, to patients with heart failure, disturbances of a cordial rhythm (risk of developing of heavy arrhythmia). At patients with the expressed coronarosclerosis emergence of tranzitorny hypotensive effect, and in some cases - decrease in perfusion of coronary arteries is possible.

Influence on ability to drive the car and to work with mechanisms. Because of possible emergence of dizziness it is recommended to be careful at control of vehicles and service of difficult mechanisms.

During administration of drug the use of alcoholic drinks is not recommended.

At the first signs of anaphylactic/anaphylactoid reactions treatment it is necessary to stop and ask for the help the doctor.

In case of drug use patients with chronic heart failure should reach previously a blood circulation compensation phase.

At the patients with a diabetes mellitus receiving treatment by insulin or peroral hypoglycemic means at use of high doses of drug strengthening of influence of these drugs on sugar level in blood is possible (see the section "Medicinal Interactions"). In these cases it is necessary to reduce a dose of insulin or peroral hypoglycemic means and to watch especially carefully the patient.

Patients with a system lupus erythematosus or other diseases of connecting fabric пентоксифиллин can appoint only after the careful analysis of possible risks and advantage.

As during treatment pentoksifilliny there is a risk of development of aplastic anemia, regular control of the general blood test is necessary.

Patients with a renal failure (clearance of creatinine      less than 30 ml/min.) or heavy dysfunction of a liver can have a slowed down removal of a pentoksifillin. Appropriate monitoring is necessary.

Especially attentive observation is necessary for patients with heavy cardiac arrhythmias, with arterial hypotonia, with the expressed atherosclerosis of brain and coronary vessels, especially at the accompanying arterial hypertension and disturbances of a cordial rhythm (at these patients at administration of drug attacks of stenocardia, arrhythmia and sharp increase in arterial pressure), with a renal failure (clearance of creatinine less than 30 ml/min. are possible), with a heavy liver failure, with the high tendency to bleedings caused, for example, by treatment by anticoagulants or disturbances of a blood coagulation (see. "Contraindication"), with stomach ulcer and a duodenum in the anamnesis, the patients who recently transferred an operative measure (the risk of developing of bleeding in this connection systematic control of level of hemoglobin and a hematocrit is necessary is increased), patients, which at the same time receive treatment pentoksifilliny and antivitamins K (see the section "Medicinal Interactions").

Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is not necessary to use drug.

Side effects:

During clinical tests and at post-marketing observation the following side effect is revealed:

From a nervous system: headache, dizziness; uneasiness, sleep disorders; spasms (aseptic meningitis – it is preferential at patients with diseases of connecting fabric).

From integuments and a hypodermic fatty tissue: a dermahemia of the person, "inflows" of blood to face skin and an upper part of a thorax, hypostases, the increased fragility of nails.

From the alimentary system: nausea, vomiting, diarrhea, dryness of a mucous membrane of an oral cavity, anorexia, an intestines atony, feeling of pressure and overflow of a stomach, an intra hepatic cholestasia (in isolated cases).

From sense bodys: vision disorder, scotoma, dacryagogue.

From cardiovascular system: tachycardia, arrhythmia, cardialgia, progressing of stenocardia (rarely), lowering of arterial pressure (rarely).

From bodies of a hemopoiesis and system of a hemostasis: thrombocytopenia (seldom), bleedings from vessels of skin, mucous membranes, a stomach, intestines (very seldom), a hypofibrinogenemia, a pancytopenia, a purpura, a leukopenia, anemia, aplastic anemia (<1%).

Allergic reactions: itch, dermahemia, small tortoiseshell, Quincke's disease, acute anaphylaxis.

Laboratory indicators: increase in activity of "hepatic" transaminases, alkaline phosphatase.

The expressed side effects are shown usually at reception of a pentoksifillin in high doses.

Interaction with other medicines:

Pentoksifillin can strengthen effect of the medicines influencing coagulant system of blood (indirect and direct anticoagulants, trombolitik), antibiotics (including cephalosporins).

Increases efficiency of hypotensive medicines (including APF inhibitors), insulin and peroral hypoglycemic medicines (the increased risk of development of a hypoglycemia). The risk of hypotension at combined use with the drugs capable to cause decrease in the ABP increases (for example, with the drugs containing nitro compounds).

Cimetidinum increases concentration of a pentoksifillin in plasma (risk of emergence of side effects).

It is not recommended to accept пентоксифиллин along with ketorolaky as the risk of bleeding and/or lengthening of a prothrombin time increases.

The concomitant use of a pentoksifillin and theophylline can lead at some patients to increase in concentration in plasma of theophylline and to the subsequent strengthening of side effects of theophylline.

Erythromycin: there are no data on possible interaction of a pentoksifillin and erythromycin. However simultaneous use of erythromycin and a teomitsin led to the substantial increase of level of theophylline in blood serum which was followed by toxic reactions.

Sympathomimetics and xanthines: co-administration with other xanthines or with sympathomimetics can lead to excessive stimulation of the central nervous system.

Contraindications:

Hypersensitivity to a pentoksifillin and other derivatives of xanthine, an acute myocardial infarction, massive bleeding, a hemorrhagic stroke, an eye retinal apoplexy, pregnancy, the lactation period, age up to 18 years (efficiency and safety are not studied).

Overdose:

Symptoms: dizziness, desires on vomiting, the expressed lowering of arterial pressure,  tachycardia, arrhythmia, excitement, a loss of consciousness, an areflexia, toniko-clonic spasms, a fever, heat, a hyperemia of integuments, symptoms of gastrointestinal bleeding (vomiting like "coffee thick").

The first symptoms of overdose can include nausea and hypotension.

Treatment: symptomatic therapy (including the measures directed to maintenance of breath and arterial pressure, activity of cardiovascular system), urgent actions at bleeding, at spasms – diazepam.

Storage conditions:

In the place protected from light and moisture at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 25 tablets in a blister strip packaging. 3 blister strip packagings with the instruction on a medical use in a pack cardboard.