Pentoxifylline 100 mg Tablets No. 50

Pentoxifylline (Pentoxiflilin) Instructions for use

Composition:

active ingredient: pentoxifylline; 1 tablet contains pentoxifylline 100 mg;
auxiliary substances: lactose monohydrate, starch potato, magnesium stearate, gipermellose (hydroxypropylmethylcellulose), povidone, methacrylate copolymer dispersion, propylene glycol, talc, titanium dioxide (E 171), carmoisin (E 122).

Dosage form

Pills are digestive.

Pharmacotherapeutic group

Peripheral vasodilators. Pentoxifylline Code АТС С04А D03.

Clinical characteristics

Indications

Atherosclerotic encephalopathy; ischemic cerebral stroke, dyscirculatory encephalopathy; disturbance of peripheral circulation due to atherosclerosis, diabetes mellitus (incl. diabetic angiopathy), inflammation; trophic disorders in the tissues, associated with damage to the veins or microcirculation (posttrombophlebitis syndrome, trophic ulcers, gangrene, defecation); obliterating endarteritis; angioneuropathy (Raynaud's disease); disturbance of blood circulation of the eye (acute, subacute, chronic circulatory failure in the retina and vasculature of the eye); disturbance of the function of the inner ear of the vascular genesis, which is accompanied by a decrease in hearing.

Contraindications

Pentoxifylline is contraindicated:

• Patients with a high sensitivity to pentoxifylline, to other methylxanthines or to any of the excipients of the drug;
• patients with massive hemorrhage (risk of hemorrhage);
• Patients with extensive hemorrhage in the retina of the eye, with hemorrhages in the brain (the risk of increased bleeding). If bleeding occurs in the retina during treatment with pentoxifylline, the drug should be discontinued immediately;
• patients with hemorrhage in the brain;
• patients in acute period of myocardial infarction;
• patients with gastric ulcer and / or intestinal ulcers;
• patients with hemorrhagic diathesis.

Method of administration and dose

Pentoxifylline should be prescribed 2-4 tablets 2-3 times a day. Pills should be taken after a meal without chewing, drinking enough liquid. The maximum daily dose should not exceed 1.2 g.

For patients with labile or decreased arterial pressure or significant reduction in renal function (clearance of creatinine less than 30 ml / min); for patients at a special risk of the effects of lowering blood pressure (for example, with severe coronary artery disease, severe cerebral vascular stenosis) it is necessary to start treatment with low doses, to select doses individually and to increase them gradually, taking into account the tolerability of the treatment.

Adverse reactions

Some patients may have side effects, namely:

• from the cardiovascular system: arrhythmia, tachycardia, angina pectoris, arterial hypotension / hypertension, sensation of heat (tides), peripheral edema;
• on the part of the blood and blood forming organs: thrombocytopenia with thrombocytopenic purpura, aplastic anemia (partial or complete cessation of formation of all blood cells, pancytopenia), which may have lethal outcome, bleeding;
• from the nervous system: dizziness, headache, aseptic meningitis, tremor, paresthesia, convulsions, arousal and disruption of sleep, hallucinations;
• from the gastrointestinal tract: gastrointestinal disturbances, stomach upset, flatulence, nausea, vomiting or diarrhea;
• on the skin and subcutaneous tissues: itching, reddening of the skin and urticaria, toxic epidermal necrolysis and Stevens-Johnson syndrome;
• from the immune system: anaphylactic reactions, anaphylactoid reactions, angioneurotic edema, bronchospasm and anaphylactic shock;
• from the side of the liver and the biliary tract: intrahepatic cholestasis;
• from the side of the vision organs: vision impairment, conjunctivitis, hemorrhage in the retina, retreatment of the retina;
• laboratory parameters: increase of transaminases level;
• others: cases of hypoglycemia, hyperhidrosis, and fever were reported.

Overdose

The initial symptoms of acute overdose with pentoxifylline are nausea, dizziness, or low blood pressure. In addition, symptoms such as fever, agitation, sensation of heat (hot flushes), loss of consciousness, arrelexia, tonic-clonic seizures and vomiting of the color of the brown area as a sign of gastrointestinal bleeding may develop .

Treatment of overdose

The specific antidote is unknown. If overdoses have just occurred, measures should be taken to prevent further systemic absorption of the active substance by primary elimination (for example, gastric lavage) or to prevent its absorption (for example, using activated charcoal).

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

Use during pregnancy or breastfeeding

Due to insufficient experience of using the drug in pregnant women, it is not recommended to prescribe it during pregnancy.

If you need to use the product, stop breast-feeding, as pentoxifylline in small amounts penetrates into breast milk.

Where are you

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

Application features

With the first signs of anaphylactic / anaphylactoid reaction, treatment with Pentoxifylline should be stopped and seek medical advice.

In the case of using the drug in patients with chronic heart failure, blood circulation compensation phases should be preliminarily achieved. Patients suffering from diabetes and receiving insulin or oral antidiabetic medication may increase the effect of these drugs on blood sugar levels when using high doses of the drug (see section "Interaction with other drugs and other types of interactions"). In these cases, the dose of insulin or oral antidiabetic agents should be reduced and care should be taken especially at the patient. Patients with systemic lupus erythematosus (SCL) or other pentoxifylline connective tissue disease can only be prescribed after careful analysis of possible risks and benefits.Since there is a risk of developing aplastic anemia during treatment with pentoxifylline, regular monitoring of the general blood test 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. Proper monitoring is required.

Particularly attentive care is required for:

• patients with severe cardiac arrhythmias;
• patients with myocardial infarction;
• patients with arterial hypotension;
• patients with marked atherosclerosis of cerebral and coronary vessels, especially with concomitant arterial hypertension and heart rhythm disorders. In these patients, when taking the drug, possible attacks of angina, arrhythmias and arterial hypertension;
• patients with renal insufficiency (creatinine clearance below 30 ml / min);
• patients with severe hepatic insufficiency;
• Patients with a high inclination to bleeding due to, for example, treatment with anticoagulants or blood clotting disorders. Regarding bleeding - see section "Contraindications";
• patients with history of gastric and duodenal ulcers, patients who have recently undergone surgical treatment (an increased risk of bleeding, which necessitates systematic monitoring of hemoglobin and hematocrit levels);
• of patients receiving concomitant treatment with pentoxifylline and anti-vitamins K (see section "Interaction with other drugs and other types of interactions");
• Patients who are simultaneously treated with pentoxifylline and anti-diabetic agents (see section "Interaction with other drugs and other types of interactions").

The drug contains lactose, therefore, the drug should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Ability to influence the reaction speed when driving or operating with other mechanisms

There is no data, however, the possibility of adverse reactions from the nervous system and the organs of vision should be taken into account.

Interaction with other drugs and other types of interactions

Patients who receive medical treatment for diabetes should be under close medical supervision, as the effect of reducing blood sugar levels inherent in insulin or oral antidiabetic agents may be increased. In the postmarketing period, cases of anticoagulant activity in patients who were simultaneously treated with pentoxifylline and anti-vitamins C were reported. When the dose of pentoxifylline was administered or changed, it is recommended that anticoagulant activity is monitored in this group of patients. Pentoxifylline may exacerbate the hypotensive effects of antihypertensive drugs and other drugs that may cause a decrease in blood pressure. The simultaneous use of pentoxifylline and theophylline in some patients may result in an increase in the level of theophylline in the blood, so it is possible to increase the frequency and increase the manifestations of the adverse reactions of theophylline.

Pharmacological properties

Pharmacodynamics.

Pentoxifylline refers to peripheral vasodilators with angioprotective effect. Improves microcirculation and rheological properties of blood by expanding blood vessels, reducing platelet aggregation, increasing the elasticity of red blood cells and reducing blood viscosity. The drug improves the supply of oxygen by tissues. The mechanism of action is due to blockade of adenosine receptors, blockade of phosphodiesterase and accumulation of cAMP in platelets.

Pharmacokinetics.

Pentoxifylline is rapidly absorbed in the digestive tract. When the first passes through the liver, a number of pharmacologically active metabolites are formed. The maximum concentration in blood plasma is reached 1 hour after ingestion and significantly reduced after 8 hours - less than 10% of the administered dose. Most (about 94%) is excreted in the urine in the form of non-toxic metabolites. Less than 4% of the dose is excreted with feces.

In patients with severe renal impairment, excretion of metabolites is slowed down. In patients with impaired liver function, the half-life is increased.

Pharmaceutical characteristics

Basic physical and chemical properties: pills of round shape, coated, pink, the upper and lower surfaces of which are convex. At a break, when viewed under a magnifying glass, a kernel, surrounded by one solid layer, is visible.

Shelf life

3 years.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Packaging

• 10 tablets in blisters;
• 10 tablets in a blister; 5 blister packs in cardboard.

Vacation category

By recipe