Isopascus (Isopask)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAminosalicylic acid + IsoniazidAminosalicylic acid + Isoniazid
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  • Isopascus
    pills inwards 
    FARMASINTEZ, JSC (Irkutsk)     Russia
  • IAC-PAS Plus
    granules inwards 
    McLeodz Pharmaceuticals Co., Ltd.     India
    • Dosage form: & nbsptablets coated with enteric film coating
    Composition:

    Active substances:

    Sodium para-aminosalicylate 1.145 g;

    Isoniazid - 0.0333 g.

    Excipients:

    Core:

    Ethyl cellulose 0.0008 g; cellulose microcrystalline - 0.043 g; povidone medium-molecular (polyvinylpyrrolidone, medium molecular weight, collidon 25) - 0.061 g; carboxymethyl starch sodium (primogel) - 0.0489 g; magnesium hydroxylate (talc) 0.005 g; magnesium stearate - 0.005 g; Tween 80 (polysorbate 80) - 0.004 g.

    Shell:

    The final film shell is 0.140 g.

    Shell composition:

    Gipromellosis - 9.3%; ethyl cellulose 10 - 1.16%; diethyl phthalate 1.6%; Macrogol-6000 - 2.10%; triethyl citrate - 7,10%; titanium dioxide - 4,10%; talc - 17.46%; colliquot (methacrylic acid and ethyl acrylate copolymer [1: 1]) - 53.61%; dye sunset yellow aluminum varnish (17-19%) - 3.57%.

    Description:Tablets of the oval form of orange color.
    Pharmacotherapeutic group:Anti-tuberculosis drug combined
    ATX: & nbsp

    J.04.A.C.01   Isoniazid

    J.04.A.A.01   Aminosalicylic acid

    Pharmacodynamics:

    Sodium para-aminosalicylate has a bacteriostatic effect on Mycobacterium tuberculosis. The mechanism of action is associated with the 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.

    Sodium para-aminosalicylate acts on mycobacteria, which are in a state of active reproduction, and practically does not affect the mycobacteria at rest.

    Slightly affects the pathogen, located intracellularly.

    Sodium para-aminosalicylate is active only in relation to M. tuberculosis. Does not affect other non-tuberculous mycobacteria.

    Sodium para-aminosalicylate reduces the likelihood of bacterial resistance to streptomycin and isoniazid.

    Isoniazid acts bactericidal, inhibits the synthesis of mycolic acids, which are an important component of the cell wall of mycobacteria. It is especially active against rapidly multiplying microorganisms (including those located intracellularly).

    Pharmacokinetics:

    The drug is well absorbed when taken orally. The maximum concentration of active components with a single dose is noted after 1-2 hours. Well distributed throughout the body. Metabolised in the liver.In urine is defined as acetylated inactive metabolites. The total clearance depends on both the metabolic rate and the excretion of the kidneys. Small amounts are released through the intestine. Sodium para-aminosalicylate increases the concentration of isoniazid in the blood.

    Indications:

    Tuberculosis (various forms and localizations) with MDR, acutely progressive, widespread pulmonary tuberculosis.

    Contraindications:

    Hypersensitivity, epilepsy, including history, renal failure, hepatic insufficiency, hepatitis, liver cirrhosis, amyloidosis of internal organs, peptic ulcer of stomach and duodenum, enterocolitis (exacerbation), myxedema (uncompensated), decompensated chronic heart failure (including against a heart defect), thrombophlebitis, hypocoagulation, pregnancy, lactation, psoriasis.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    Inside, after eating, squeezed with water (150 ml). Calculation of the dose of isopaska is carried out according to the pacifier, depending on the weight of the patient's body. At a body weight of 30 kg 4 tablets are assigned, 40 kg - 6 tablets, 50 kg - 8 tablets, 60 kg - 10 tablets. Do not administer more than 10 tablets.

    Isopaska reception 2 times a day.

    Side effects:

    Decreased appetite, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, hepatomegaly, increased activity of "hepatic" transaminases, hyperbilirubinemia, proteinuria, hematuria, crystalluria. Rarely - thrombocytopenia, leukopenia (up to agranulocytosis), drug-induced hepatitis, B 12-deficient megaloblastic anemia. Allergic reactions - fever, dermatitis (urticaria, purpura, enanthema) eosinophilia, arthralgia, bronchospasm. With prolonged use in high doses - hypothyroidism, goiter, myxedema.

    Interaction:

    FROM caution should be combined with potentially neuro-, hepato- and nephrotoxic drugs because of the risk of side effects. Strengthens the action of coumarin and indandione, benzodiazepines, theophylline. Glucocorticosteroids accelerate metabolism in the liver and reduce active concentrations in the blood. It is not recommended to prescribe isopask with rifampicin and rifamputin, since the pas squeezes the absorption of these drugs.

    Special instructions:

    Used in combination with more active anti-tuberculosis drugs. When treatment is recommended to monitor the activity of "liver" transaminases.Decreased kidney function against tuberculous intoxication or specific damage is not a contraindication to the appointment. When there are signs of toxic hepatitis, the development of proteinuria and hematuria requires a temporary withdrawal of the drug.

    Form release / dosage:

    Tablets coated with enteric film coating, 1,145 g + 0,0333 g.

    Packaging:For 100, 372 or 500 tablets in a polymer bank.
    Storage conditions:

    At a temperature of no higher than 25 ° C, in a dry, dark place out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the time specified on the package.
    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-003130/08
    Date of registration:25.04.2008 / 06.09.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.10.2017
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