Active substanceAminosalicylic acidAminosalicylic acid
Similar drugsTo uncover
  • Aquapasc®
    pills inwards 
    VALENTA PHARM, PAO     Russia
  • Amictobin
    pills inwards 
  • Aminosalicylic acid
    pills inwards 
    NIZHFARM, JSC     Russia
  • Aminosalicylic acid
    solution d / infusion 
    KRASFARMA, JSC     Russia
  • Aminosalicylic acid
    lyophilizate d / infusion 
  • Aminosalicylic acid
    granules inwards 
    ZIO-HEALTH, JSC     Russia
  • Aminosalicylic acid
    pills inwards 
    NIZHFARM, JSC     Russia
  • Verpas-SR
    granules inwards 
  • MAK-PAS®
    granules inwards 
  • Monopas®
    granules inwards 
  • Sodium para-aminosalicylate
    pills inwards 
    OZONE, LLC     Russia
  • Sodium para-aminosalicylate
    pills inwards 
  • Sodium para-aminosalicylate
    pills inwards 
    HEALTH OF CNT, CJSC     Russia
  • Sodium para-aminosalicylate
    pills inwards 
    ZIO-HEALTH, JSC     Russia
  • Sodium para-aminosalicylate
    granules inwards 
  • Sodium para-aminosalicylate
    pills inwards 
  • Pasers
    granules inwards 
  • Para-aminosalicylate sodium
    lyophilizate d / infusion 
  • Para-aminosalicylate sodium-Binergium
    solution d / infusion 
    BINERGIYA, CJSC     Russia
  • PAS Sodium
    granules inwards 
    Rowecq Limited     United Kingdom
  • PAS-Fatol H
    lyophilizate d / infusion 
  • PASK®
    pills inwards 
  • PASK sodium salt
    lyophilizate d / infusion 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • PASK-Acry®
    pills inwards 
    AKRIKHIN HFK, JSC     Russia
  • Pasconate®
    solution d / infusion 
    YURIYA-FARM, LLC     Ukraine
  • Simpas
    pills inwards 
  • Simpas
    pills inwards 
    KORAL-MED, CJSC     Russia
  • Faminoalk
    pills inwards 
  • Dosage form: & nbspsustained-release granules for oral administration
    Composition:

    One package contains:

    Active substance:

    Aminosalicylic acid 4.0 g.

    Excipients: cellulose microcrystalline 1,2997 g. methacrylic acid copolymer 0.71 g, talc 0.30 g, silicon dioxide colloid 0.01 g.

    Composition of the granule shell: dibutyl sebacate 0.08 g, talc 0.02 g, hypromellose 0.08 g, dye sunset yellow 0.0003 g.

    Description:Granules of spherical shape, covered with a shell of red-orange color, odorless.
    Pharmacotherapeutic group:Antituberculous
    ATX: & nbsp

    J.04.A.A.01   Aminosalicylic acid

    Pharmacodynamics:

    Aminosalicylic acid has a bacteriostatic effect against Mycobacterium tuberculosis, reduces the likelihood of bacterial resistance to streptomycin and isoniazid. The mechanism of action is associated with inhibition of the synthesis of folic acid and with the suppression of the formation of mycobacterium, a component of the mycobacterial wall, which leads to a decrease in the capture of iron M. tuberculosis. Aminosalicylic acid acts against actively multiplying Mycobacterium tuberculosis (MIC of 1-5 μg / ml). Virtually does not work on Mycobacterium tuberculosis in the stage of rest and located intracellularly. Does not affect other mycobacteria. It is used only in combination with other anti-tuberculosis drugs.

    Pharmacokinetics:

    Suction. Well absorbed in the gastrointestinal tract. After ingestion by healthy volunteers in a dose of 4 g with food, the time to reach the maximum concentration 6 hours (varied from 1.5 to 24 hours); the mean maximum plasma concentration is 20 μg / ml, varying from 9 to 35 μg / ml; the concentration of 2 μg / ml persists an average of 7.9 hours (from 5 to 9 hours); the concentration of 1 μg / ml is maintained on average 8.8 hours (from 6 to 11.5 hours).

    Distribution. Binding to plasma proteins - 50-60%. It is well distributed in tissues and body fluids, kidneys, lungs, liver. Achieves high concentrations in pleural efflorescence and caseous tissue. In the cerebrospinal fluid penetrates moderately (only with inflammation of the meninges). Penetrates into breast milk.

    Metabolism. Metabolized in the liver (more than 50% acetylated to inactive metabolites). The process of acetylation is not genetically determined, as is the case with isoniazid.

    Excretion. It is excreted by glomerular filtration and tubular secretion. 80% of the dose is excreted by the kidneys, of which 50% is metabolites.

    Indications:Tuberculosis of various shapes and locations (in combination with other anti-TB drugs), including multidrug resistance to other anti-TB drugs.
    Contraindications:

    Hypersensitivity to aminosalicylic acid (including other salicylates..), Other ingredients: idiosyncrasy salicylates (history); arterial hypertension; deficiency of glucose-6-phosphate dehydrogenase; edema,caused by hyponatraemia; severe kidney and liver diseases (severe renal and / or liver failure, nephritis of tuberculosis etiology, cirrhosis); decompensated chronic heart failure; peptic ulcer of the stomach and duodenum, inflammatory bowel disease in the stage of exacerbation: amyloidosis of internal organs; decompensated hypothyroidism; thrombophlebitis, hypocoagulation; epilepsy: the period of breastfeeding: children under 3 years (for this dosage form).

    Carefully:

    Renal / hepatic insufficiency of moderate and mild severity, compensated hypothyroidism, chronic heart failure, gastrointestinal diseases (in the anamnesis), acute hepatitis, diabetes mellitus.

    Pregnancy and lactation:

    Possible use of the drug in pregnancy, only if the expected benefit for the mother exceeds the potential risk to the fetus.

    If it is necessary to use the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, after eating, washed down with acidic solutions (juices: orange, tomato, apple).Do not chew the granules. With increased acidity of gastric juice, the drug should be washed down with water.

    Adults 12 grams per day (4 g 3 times a day), children older than 3 years - at a rate of 0.15-0.2 g / kg per day in 3-4 doses (daily dose of not more than 10 g). In exhausted adult patients (with a body weight of less than 50 kg), as well as with poor tolerance, the drug is used in a dose of 6 g per day.

    With concomitant diseases of the gastrointestinal tract, the maximum daily dose is 4-6 g.

    In conditions of outpatient treatment, the entire daily dose can be used for one dose (in case of good tolerability).

    The number of courses and the total duration of treatment are determined individually.
    Side effects:

    From the digestive system: decreased or loss of appetite, increased salivation, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, heartburn; increased activity of "hepatic" transaminases, hyperbilirubinemia, jaundice; drug-induced hepatitis (including fatal), hepatomegaly, partially pronounced malabsorption syndrome, bleeding peptic ulcers.

    From the hematopoiesis: thrombocytopenia, neutropenia, lengthening prothrombin time, accompanied by bleeding and hemorrhagic purpura, lymphocytosis, leukopenia (up to agranulocytosis), B 12-deficient megaloblastic anemia, hemolytic anemia with a positive Coombs breakdown.

    From the genitourinary system: proteinuria, hematuria, crystalluria, glucosuria, an increase in urea concentration in the blood plasma.

    Allergic reactions: rash (hives, purpura, enanthema, exfoliative dermatitis, a syndrome reminiscent of infectious mononucleosis or lymphoma), Quincke's edema, fever, bronchospasm, arthralgia, eosinophilia, Stevens-Johnson syndrome, Lyell's syndrome. anaphylactic shock, itching, erythema.

    Other: fever, arthralgia, sore throat, unusual bleeding and bruising, swelling of the joints, lupus-like syndrome, accompanied by lesions of the spleen, liver, kidneys, digestive tract, bone marrow and nervous system (eg, radicular pain, meningism); with prolonged use in high doses - Hypothyroidism, goiter (with or without myxedema); pericarditis, hypoglycemia, hyperglycemia, hypokalemia, optic neuritis, encephalopathy, psychosis, seizures,symptoms of paralysis, Leffler's syndrome (eosinophilic pneumonia, migratory pulmonary infiltrate), vasculitis, a decrease in prothrombin content, superinfection.

    Overdose:

    Symptoms: it is possible to increase dose-dependent side effects.

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

    Aminosalicylic acid disrupts the absorption of rifampicin. erythromycin and lincomycin. If it is necessary to use together with rifampicin, you should divide the time of taking the drugs.

    When combined with isoniazid increases its concentration in the blood plasma due to competition for common metabolic pathways.

    Simultaneous use with phenytoin may lead to an increase in the concentration of phenytoin in the blood plasma and the appearance of its toxicity.

    It interferes with the assimilation of cyanocobalamin (vitamin B12), which can lead to the development of B12 deficiency anemia. Thus, when treating patients with aminosalicylic acid for more than 1 month, vitamin B12 therapy is necessary.

    Antacids do not interfere with drug absorption. If necessary, they should be taken separately (between preparations of the drugs should be 2 hours).

    Reduces the concentration of digoxin in the blood by 40%. Digoxin dose adjustment may be required.

    Assimilates the effect of indirect anticoagulants - coumarin and indanedione derivatives (correction of the dose of indirect anticoagulants is required). It may be necessary to correct the doses of indirect anticoagulants.

    When using iodine-containing thyroid hormones, their analogs and antagonists (including antithyroid agents), it should be taken into account that the concentration of thyroxine and thyroid-stimulating hormone in the blood changes with aminosalicylic acid.

    The use of the drug together with diphenhydramine leads to a decrease in the concentration of aminosalicylic acid in the blood plasma.

    Probenecid reduces the excretion of aminosalicylic acid, increasing its concentration in the plasma.

    Simultaneous use with ethionamide increases the risk of hepatotoxicity.

    Ammonium chloride increases the risk of developing crystalluria.

    The use of the drug together with salicylates, phenylbutazone or other anti-inflammatory drugs with increased ability to bind to plasma proteins, leads to an increase in the concentration and increase in the duration of aminosalicylic acid in the blood plasma.

    Special instructions:

    Used in combination with other anti-tuberculosis drugs. At the first signs indicating an allergic reaction, the drug should be stopped immediately and symptomatic therapy should be given.

    During the treatment, it is necessary to systematically examine urine and blood and monitor liver function (activity of "liver" transaminases).

    Decreased kidney function against tuberculous intoxication or a specific lesion is not a contraindication to the appointment of aminosalicylic acid. The development of proteinuria and hematuria requires a temporary discontinuation of the drug.

    In the presence of symptoms of impaired liver function, such as increased activity of "hepatic" transaminases. jaundice, fever, drug therapy should be discontinued and conduct a study of the functional state of the liver.

    Possible detection in the stool of insoluble soft shells of granules.

    It is necessary to maintain the pH of the urine neutral or alkaline to prevent crystalluria. In patients with diabetes it is necessary to monitor the concentration of glucose in the blood plasma.

    Effect on the ability to drive transp. cf. and fur:

    There is still evidence that aminosalicylic acid has any adverse effect on a patient's ability to engage in potentially hazardous activities requiring increased attention and speed of mental and motor reactions, was not. When there are side effects from the central nervous system, care must be taken when driving vehicles and engaging in other potentially hazardous activities.

    Form release / dosage:

    Slow release granules for oral administration 4 g.

    Packaging:For 6.5 g of the drug in a package of aluminum foil; the packet is sealed. For 30 packages with 30 instructions for use are placed in a cardboard box (for hospitals).
    Storage conditions:

    In the dark place at a temperature of no higher than 25 0 FROM.

    Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:For hospitals
    Registration number:LP-004246
    Date of registration:17.04.2017
    Expiration Date:17.04.2022
    The owner of the registration certificate:Virend International, Inc.Virend International, Inc. Russia
    Manufacturer: & nbsp
    Representation: & nbspVirend International, Inc.Virend International, Inc.Russia
    Information update date: & nbsp12.05.2017
    Illustrated instructions
      Instructions
      Up