Active substancePentoxifyllinePentoxifylline
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  • Dosage form: & nbsp

    Intestinal-soluble film tablets

    shell; film-coated tablets, retard.

    Composition:

    Tablets 100 mg:

    One tablet contains:

    Pentoxifylline - 100 mg.

    Excipients: microcrystalline cellulose, calcium phosphate

    dibasic, polyvinylpyrolidone, magnesium stearate, cross-carmellose sodium, talc. Composition of the shell: methacrylic acid copolymer, diethyl phthalate, titanium dioxide, karma zinc varnish.

    Tablets 400 mg, retard:

    One retard tablet contains:

    Pentoxifylline - 400 mg.

    Excipients: Ethylcellulose, calcium phosphate is a dibasic, magnesium stearate, talc.

    Sheath composition: titanium dioxide, hydroxypropylmethyl cellulose, diethylphthalate, zinc varnish.

    Description:

    Tablets of 100 mg: Pink round, biconvex tablets, covered with a film membrane.

    Tablets of 400 mg, retard,: Pink tablets in capsule form, film-coated, with a fault line on one side.

    Pharmacotherapeutic group:vasodilator
    ATX: & nbsp

    C.04.A.D.03   Pentoxifylline

    Pharmacodynamics:

    Pentoxifylline improves microcirculation and rheological properties of blood. The mechanism of action of Pentoxifylline is associated with inhibition of phosphodiesterase and the 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 the blood and improves its rheological properties.

    Has a weak myotropic vasodilator action, Pentoxifylline slightly reduces the overall peripheral resistance and slightly dilates the coronary vessels.

    Generally, Pentoxifylline causes improvement of microcirculation and supply of tissues with oxygen in the central nervous system and in the extremities, and to a lesser extent in the kidneys.

    Pharmacokinetics:

    After oral administration Pentoxifylline quickly and almost completely absorbed from the gastrointestinal tract. The drug almost does not bind to proteins. Most Pentoxifylline is metabolized in the liver and excreted by the kidneys in the form of water-soluble metabolites (more than 90%). The half-life of Pentoxifylline is 1.6 hours. In patients with severe impairment of renal function, the excretion of metabolites is slowed. The maximum concentration of Pentoxifylline in the blood plasma after about a single oral intake is noted after 1 hour. By the 8th hour the concentration is significantly reduced (up to 10% of the initial).

    Indications:

    Pentoxifylline is used for peripheral circulatory disorders caused by atherosclerosis, diabetes mellitus (diabetic angiopathy), inflammation; acute and chronic disorders of cerebral circulation of the ischemic type; atherosclerotic and discirculatory encephalopathies; angioneuropathy (paresthesia,Raynaud's disease,); trophic tissue disorders due to the violation of arterial or venous microcirculation (trophic ulcers, postthrombophlebitic syndrome, frostbite, gangrene); obliterating endarteritis; acute, subacute and chronic circulatory insufficiency in the retina or in the choroid of the eye; hearing disorders of vascular genesis.

    Contraindications:

    Pentoxifylline is contraindicated in the following cases:

    - Hypersensitivity to Pentoxypylline, other methylxanthines or other components of the finished dosage form;

    - Acute myocardial infarction;

    - Massive bleeding;

    - Acute hemorrhagic stroke;

    - Pronounced coronary or cerebral atherosclerosis; severe cardiac rhythm disturbances;

    - Hemorrhages in the retina of the eye;

    - Pregnancy and the period of breastfeeding;

    - Age to 18 years.

    Carefully:Caution should be exercised in appointing Pentoxifylline to patients with peptic ulcer and duodenal ulcer who have recently undergone surgery (risk of bleeding). Patients with labile arterial pressure and a tendency to arterial hypotension and patients with severe impairment of functionsKidney increase gradually and select individually.
    Pregnancy and lactation:
    Dosing and Administration:

    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.

    Adult drug Pentoxifylline prescribe, starting with 0.2 g 3 times a day. Prolonged dosage forms are prescribed 2 times a day. The course of treatment is 2-3 weeks or more.

    Side effects:

    The most common adverse effects of pentoxifylline are gastrointestinal (nausea, a feeling of overflow in the abdomen, stomach spasms, vomiting, diarrhea). Sometimes dizziness and headache may occur. Occasionally one can observe lowering of arterial pressure, angina pectoris, disturbance of heart rhythm, sensation of tidal flow.

    In rare cases of hypersensitivity reactions, reddening of the skin, itching, urticaria were observed.

    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 separate reports on 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.

    Overdose:

    Clinical picture: dizziness, urge to vomit, drop in 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):

    - When the first signs (sweating, nausea, cyanosis) immediately stop taking the drug;

    - In addition to other necessary measures, the head and upper body are lower in position and provide freedom for breathing;

    - Urgent medical measures: enter / in epinephrine (adrenalin). If necessary, the introduction of epinephrine can be repeated.

    Interaction:

    Pentoxifylline is able to enhance the action of antihypertensive agents and anticoagulants.

    In patients with diabetes mellitus, who are on insulin treatment or taking antidiabetic drugs, Pentoxifylline can intensify the hypoglycemic effect of nortivodiabetic drugs, up to the occurrence of hypoglycemic reactions.

    Form release / dosage:Tablets, covered with an enteric-soluble coat of 100 mg, and 400 mg retard tablets, coated with a film coat.
    Packaging:(10) - packings, cellular, outline (1) - packs, cardboard
    (10) - packings cellular planimetric (10) - packs cardboard
    (10) - packings, cellular, outline (2) - packs, cardboard
    (10) - packings, cellular, outline (3) - packs, cardboard
    (10) - packings, cellular, outline (4) - packs, cardboard
    (10) - packings, cellular planimetric (5) - packs cardboard
    (10) - packings, cell planimetric (6) - packs cardboard
    (20) - packings, cell planimetric (1) - packs cardboard
    (20) - packings, cellular planimetric (10) - packs cardboard
    (20) - packings, cellular, outline (2) - packs, cardboard
    (20) - packings, cellular, outline (3) - packs, cardboard
    (20) - packings cellular planimetric (4) - packs cardboard
    (20) - packings, cellular planimetric (5) - packs cardboard
    (20) - packings, cellular planimetric (6) - packs cardboard
    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:3 years. Do not use after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014549 / 01-2002
    Date of registration:25.11.2008
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp25.08.2015
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