PASK-Acry - instructions for use, dose, side effects, contraindications

Shell composition: a ready-made mixture "ACRYL-IZ" (a copolymer of methacrylic acid with ethyl acrylate 1:1, titanium dioxide, talc, triethyl citrate, silicon dioxide colloidal anhydrous, sodium hydrogen carbonate, sodium lauryl sulfate), iron oxide red oxide, iron oxide yellow oxide, simethicone emulsion 30%.

Description:

The tablets, covered with a film intestine-soluble coating, pink with a brownish hue of color, oval, biconvex. At the break of a white tablet with a creamy shade of color.

Pharmacotherapeutic group:anti-tuberculosis drug

ATX: & nbsp

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

Has a bacteriostatic effect on Mycobacterium tuberculosis. Aminosalicylic acid competes with paraaminobenzoic acid and suppresses the synthesis of folate in mycobacteria tuberculosis. The drug is active against multiplying mycobacteria, practically does not affect bacteria that are at rest or located intracellularly. Reduces the likelihood of development of resistance of mycobacteria to streptomycin and isoniazid.

Pharmacokinetics:

Absorption is high. The maximum concentration in the blood plasma after taking a dose of 4 g is 75 μg / ml.Metabolised in the liver. Easily penetrates through the histogematic barriers and is distributed in tissues. High concentrations of the drug are found in the lungs, kidneys and liver. Moderately penetrates into cerebrospinal fluid only during inflammation shells, in this case aminosalicylic acid concentration in the cerebrospinal fluid of 10 - 50% concentration of drug in blood plasma. It is excreted mainly with urine (80 % of the drug is excreted within 10 hours), with 50% in the form of an acetylated derivative. The half-life is 0.5 h. Excretion is reduced in patients with impaired liver function.

Indications:

Tuberculosis (various forms and localizations) in complex therapy.

Contraindications:

Hypersensitivity, renal failure, liver failure, hepatitis, cirrhosis; amyloidosis of internal organs, peptic ulcer and 12 duodenal ulcer, enterocolitis (exacerbation), myxedema (uncompensated), nephritis, decompensated chronic heart failure (including in the face of heart disease), thrombophlebitis, hypocoagulation, pregnancy, lactation, children under 3 years.

Carefully:

Epilepsy.

Dosing and Administration:

Inside, 0.5-1 hour after meals, washed down with boiled water.

Adults - 9-12 g / day (3-4 g 3 times a day), for malnourished patients with a body weight of less than 50 kg - 6 g / day.

Children are prescribed at a rate of 0.2 g / kg / day in 3-4 divided doses, the maximum dose is 10 g / day.

In an outpatient setting, the entire daily dose can be administered in a single dose.

Side effects:

Decreased appetite, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, hepatomegaly, increased activity of "liver" 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:

Compatible with other antituberculous drugs. When combined with isoniazid increases its concentration in the blood. Violates the absorption of rifampicin, erythromycin and lincomycin. It interferes with the absorption of vitamin B12 (the risk of anemia increases).

Special instructions:

Used in combination with antituberculous 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. The development of proteinuria and hematuria require a temporary discontinuation of the drug.

Form release / dosage:

Tablets, coated with enteric coating, 1 g.

Packaging:

For 50 or 100 tablets in a jar of polypropylene (polyethylene).

Each bank along with instructions for use in a pack of cardboard.

For 500 tablets in a bag of polyethylene film. A polyethylene bag together with instructions for use in a container made of polypropylene (polyethylene) (for hospital).

Storage conditions:

List B. In a dry, the dark 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 expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N002565 / 01

Date of registration:21.05.2008

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp10.06.2010

Illustrated instructions

Instructions

PASK-Acry® (PASK-Akri®)