Composition, form of production and packaging
Tablets covered with an enteric-coated shell of pink color, film; round, biconcave.
pentoxifylline 100 mg
Excipients: cellulose microcrystalline, calcium phosphate dibasic, polyvinylpyrrolidone, magnesium stearate, sodium croscarmellose, talc.
Sheath composition: methacrylic acid copolymer, diethyl phthalate, titanium dioxide, carmosein varnish.
10 pieces. - blisters (6) - packs of cardboard.
Retard tablets coated with a pink film shell in the form of capsules, with a fault line on one side.
pentoxifylline 400 mg
Excipients: ethylcellulose, calcium phosphate dibasic, magnesium stearate, talc.
Sheath composition: titanium dioxide, hydroxypropylmethylcellulose, diethylphthalate, carmosein varnish.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
Vasodilator. Pentoxifylline improves microcirculation and rheological properties of blood. The mechanism of action of Pentoxifylline is associated with inhibition of phosphodiesterase and accumulation of CAMP in the cells of the smooth muscles of blood vessels and blood cells. Pentoxifylline inhibits the aggregation of platelets and erythrocytes, increases their elasticity, reduces the level of fibrinogen in the plasma and enhances fibrinolysis, which reduces the viscosity of blood and improves its rheological properties.
Has a weak myotropic vasodilator effect. Pentoxifylline somewhat reduces the overall peripheral resistance and slightly dilates the coronary vessels.
In general, Pentoxifylline causes an improvement in microcirculation and supply of tissues with oxygen in the central nervous system and in the extremities, and to a lesser extent in the kidneys.
After ingestion, pentoxifylline is rapidly and almost completely absorbed from the digestive tract. C max pentoxifylline in the blood plasma after a single oral intake is noted after 1 hour. By the 8th hour the concentration is significantly reduced (up to 10% of the initial).
The drug almost does not bind to proteins.
Most of pentoxifylline is metabolized in the liver and excreted by the kidneys in the form of water-soluble metabolites (more than 90%).
T 1/2 of pentoxifylline is 1.6 hours.
In patients with severe impairment of renal function, the excretion of metabolites is slowed.
- violations of peripheral circulation, caused by atherosclerosis, diabetes (diabetic angiopathy), inflammation;
- acute and chronic disorders of cerebral circulation of the ischemic type;
- Atherosclerotic and dyscirculatory encephalopathies;
- angioneuropathy (paresthesia, Raynaud's disease);
- trophic tissue disorders due to violation of arterial or venous microcirculation (trophic ulcers, postthrombophlebitic syndrome, frostbites, gangrene);
- acute, subacute and chronic circulatory insufficiency in the retina or in the choroid of the eye;
- hearing disorders of vascular genesis.
The duration of treatment and the dosage regimen of Pentoxifylline are established by the attending physician individually, depending on the clinical picture of the disease and the therapeutic effect obtained.
The drug is taken orally right after eating, without chewing, squeezed with enough liquid.
Adults prescribe the drug, starting with 200 mg 3 times / day.
Prolonged dosage forms are prescribed 2 times / day. The course of treatment is 2-3 weeks or more.
The most common adverse effects of pentoxifylline are gastrointestinal symptoms (nausea, a feeling of overflow in the abdomen, stomach spasms, vomiting, diarrhea). Sometimes dizziness and headache may occur. Occasionally, a decrease in blood pressure, angina pectoris, a disturbance of the heart rhythm, a sensation of tidal flow can be observed.
In rare cases, reactions of increased sensitivity observed reddening of the skin, itching, hives.
In some cases, jaundice (intrahepatic cholestasis) and elevated liver enzymes (transaminase, alkaline phosphatase) may appear.
In isolated cases, the emergence of very severe hypersensitivity reactions - angioedema, developing within a few minutes after taking Pentoxifylline, convulsive spasm of the muscles of the bronchi, anaphylactic shock.
At the first sign of a hypersensitivity reaction, it is necessary to stop taking the drug and consult a doctor immediately.
There are some reports of the possibility of bleeding (in the gastrointestinal tract, in the skin, in the mucous membranes), thrombocytopenia and aplastic anemia. In this regard, the treatment with Pentoxifylline requires regular monitoring of the blood picture.
acute myocardial infarction;
- massive bleeding;
- acute hemorrhagic stroke;
- severe coronary or cerebral atherosclerosis;
- marked violations of the rhythm of the heart;
- hemorrhages in the retina of the eye;
- pregnancy and the period of breastfeeding;
- age up to 18 years;
- hypersensitivity to pentoxifylline, other methylxanthines or other components of the finished dosage form.
Caution should be exercised when administering pentoxifylline to patients with peptic ulcer and duodenal ulcer who have recently undergone surgical intervention (risk of bleeding). Patients with labile arterial pressure and a tendency to arterial hypotension and patients with severe renal dysfunction increase the dose gradually and select individually.
PREGNANCY AND LACTATION
Contraindication: pregnancy and the period of breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be exercised when administering pentoxifylline to patients with severe renal dysfunction: the dose is increased gradually and selected individually.
APPLICATION FOR CHILDREN
Contraindication: age to 18 years.
Clinical picture: dizziness, urge for vomiting, falling blood pressure, tachycardia, reddening of the skin, loss of consciousness, fever (chills), agitation, areflexia, tonic-clonic convulsions, vomiting "coffee grounds", arrhythmias.
Treatment of an overdose is symptomatic. Particular attention should be paid to maintaining blood pressure and respiratory function. Convulsive seizures are removed by the introduction of diazepam.
Urgent measures in the event of severe anaphylactic reactions (shock):
- with the appearance of the first signs (sweating, nausea, cyanosis) immediately stop taking the drug;
- In addition to other necessary measures, they provide a lower position of the head and upper body and provide freedom for breathing;
- urgent medical measures: injected into / in epinephrine (adrenaline). If necessary, the introduction of epinephrine can be repeated.
Pentoxifylline is able to enhance the action of antihypertensive agents and anticoagulants.
In patients with diabetes mellitus, who are on treatment with insulin or taking antidiabetic drugs, Pentoxifylline may enhance the hypoglycemic effect of antidiabetic drugs, up to the occurrence of hypoglycemic reactions.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place inaccessible to children at a temperature not exceeding 25 В° C. Shelf life - 3 years.