Medicinal reference book geotar. Pask-akri: instructions for use International non-proprietary name

Dosage form: enteric coated tablets Compound:

One tablet contains:

active substance - sodium aminosalicylate dihydrate - 1 g;

Excipients : sorbitol, povidone (Kollidon 90 F), calcium stearate, talc, citric acid.

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

Description:

Tablets, film-coated, enteric-coated, pink with a brownish tint, oval, biconvex. On a break of a tablet of white color with a creamy shade.

Pharmacotherapeutic group:anti-tuberculosis drug ATX:

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

Has a bacteriostatic effect on Mycobacterium tuberculosis. Aminosalicylic acid competes with para-aminobenzoic acid and inhibits folate synthesis in Mycobacterium tuberculosis. The drug is active against multiplying mycobacteria, has practically no effect on bacteria that are at rest or located intracellularly. Reduces the likelihood of developing resistance of mycobacteria to streptomycin and isoniazid.

Pharmacokinetics:

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

Indications:

Tuberculosis ( various forms and localization) in complex therapy.

Contraindications:

Hypersensitivity, renal failure, liver failure, hepatitis, cirrhosis of the liver; amyloidosis internal organs, peptic ulcer stomach and duodenum, enterocolitis (exacerbation), myxedema (uncompensated), nephritis, decompensated CHF (including on the background of heart disease), thrombophlebitis, hypocoagulation, pregnancy, lactation, childhood up to 3 years.

Carefully:

Epilepsy.

Dosage and administration:

Inside, 0.5-1 hour after eating, drinking boiled water.

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

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

In the conditions of outpatient treatment, you can prescribe the entire daily dose in one 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, B12-deficiency 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 anti-TB drugs medicines. When combined with isoniazid, it increases its concentration in the blood. Violates the absorption of rifampicin, erythromycin and lincomycin. Violates the absorption of vitamin B12 (increases the risk of anemia).

special instructions:

Used in combination with anti-tuberculosis drugs.

A decrease in kidney function against the background of tuberculous intoxication or a specific lesion is not a contraindication to the appointment. The development of proteinuria and hematuria require temporary discontinuation of the drug.

Release form / dosage:

Enteric-coated tablets, 1 g

Package:

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

Each bank together with the application instruction in a pack from a cardboard.

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

Storage conditions:

List B. In a dry, dark place, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Best before date:

3 years. Do not use after the expiration date.

One tablet contains:

active substance - sodium aminosalicylate dihydrate - 1000 mg;

excipients: sorbitol, povidone (Kollidon 90 F), calcium stearate, talc, citric acid.

The composition of the shell: a ready-made mixture of "ACRYL-IZ" pink, a copolymer of methacrylic acid with ethyl acrylate 1: 1, titanium dioxide (E 171), talc, triethyl citrate, colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, iron dye red oxide (E 172 ), iron dye yellow oxide (E 172), simethicone emulsion 30%.

Description

Tablets, film-coated, enteric-coated, pink with a brownish tint, oval, biconvex. On a break of a tablet of white color with a creamy shade.

Pharmacotherapeutic group

Anti-tuberculosis drugs. Aminosalicylic acid and its derivatives. Aminosalicylic acid.

ATX code J04AA01

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

Absorption is high. The maximum concentration in blood plasma after taking a dose of 4 g is 75 mcg / ml. Metabolized in the liver. Easily penetrates through histohematic barriers and is distributed in tissues. High concentrations of the drug are found in the lungs, kidneys and liver. Moderately penetrates into the cerebrospinal fluid only when the membranes are inflamed, in this case the concentration of aminosalicylic acid in the cerebrospinal fluid is 10-50% of the concentration of the drug in the blood plasma. It is excreted mainly in the 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 hours. Excretion is reduced in patients with impaired liver function.

Pharmacodynamics

Aminosalicylic acid has a bacteriostatic effect against Mycobacterium tuberculosis.

Mechanism of action: aminosalicylic acid competes with para-aminobenzoic acid (PABA) and inhibits the synthesis of folic acid in mycobacterium tuberculosis, inhibits the formation of mycobactin, a component of the mycobacterial wall, which leads to a decrease in the uptake of iron by Mycobacterium tuberculosis. Aminosalicylic acid acts on mycobacteria that are in a state of active reproduction, and has practically no effect on mycobacteria in the resting stage. Weakly affects the pathogen, located intracellularly. It is active only against Mycobacterium tuberculosis, does not affect other non-tuberculous mycobacteria.

Reduces the likelihood of developing bacterial resistance to streptomycin and isoniazid.

In addition to antibacterial activity, the drug has a desensitizing and anti-inflammatory effect, somewhat changes the nature of tissue reactions to damage and promotes partial resorption of caseous masses.

Indications for use

Tuberculosis (various forms and localizations) in complex therapy.

Dosage and administration

Inside, 0.5-1 hour after eating, drinking boiled water, alkaline mineral water.

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

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

In the conditions of outpatient treatment, you can prescribe the entire daily dose in one dose.

Side effects"type="checkbox">

Side effects

Decreased appetite, nausea, vomiting, flatulence, abdominal pain, diarrhea, or constipation

Hepatomegaly, increased activity of "liver" transaminases, hyperbilirubinemia; proteinuria, hematuria, crystalluria

Thrombocytopenia, leukopenia (up to agranulocytosis), drug-induced hepatitis, B12-deficiency megaloblastic anemia

Allergic reactions: fever, dermatitis (urticaria, purpura, enanthema), eosinophilia, arthralgia, bronchospasm

With prolonged use in high doses - hypothyroidism, goiter, myxedema

Contraindications

Hypersensitivity

Renal and liver failure

Hepatitis, cirrhosis of the liver

Amyloidosis of internal organs

Peptic ulcer of the stomach and duodenum, enterocolitis (exacerbation)

Myxedema (uncompensated)

Nephritis decompensated CHF (including on the background of heart disease)

Thrombophlebitis, hypocoagulation

Epilepsy

Pregnancy and lactation

Children's age up to 3 years

Drug Interactions"type="checkbox">

Drug Interactions

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

special instructions

Used in combination with anti-tuberculosis drugs.

Features of the effect of the drug on the ability to drive vehicle or potentially dangerous mechanisms

Given the side effects of the drug, care must be taken when performing these activities.

Overdose

Symptoms: possible increase in side effects.

Treatment: drug withdrawal, symptomatic therapy.

Application for violations of liver function

The drug is contraindicated in liver failure.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Release form, composition and packaging

Enteric coated tablets pink with a brownish tint, oval, biconvex; on a break - white with a creamy shade of color.

Excipients: sorbitol, povidone (kollidone 90F), calcium stearate, talc, citric acid.

Shell composition: ready mix "ACRYL-IZ" (copolymer of methacrylic acid with ethyl acrylate (1:1), titanium dioxide, talc, triethyl citrate, anhydrous colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate), iron dye red oxide, iron dye yellow oxide, simethicone emulsion thirty%.

100 pieces. - polymeric containers.
500 pcs. - polymeric containers.

Clinico-pharmacological group: Anti-tuberculosis drug Pharmaco-therapeutic group: Anti-tuberculosis drug

Terms and conditions of storage

List B. In a dry, dark place, at a temperature not exceeding 25 ° C. Keep out of the reach of children

Shelf life 3 years. Do not use after the expiration date.

Contraindications for use

Hypersensitivity;

kidney failure;

Liver failure;

Hepatitis;

Cirrhosis of the liver;

Amyloidosis of internal organs;

peptic ulcer and duodenum;

Enterocolitis (exacerbation);

Myxedema (uncompensated);

Decompensated chronic heart failure (including against the background of heart disease);

thrombophlebitis;

hypocoagulation;

Pregnancy;

Lactation;

Children's age up to 3 years.

Carefully with epilepsy.

Indications

Tuberculosis (various forms and localizations) in complex therapy.

ICD-10 codes

Dosage form

Registration certificate holder:

Chemical-pharmaceutical plant AKRIKHIN, JSC(Russia)

Pharmacokinetics

Absorption is high. C max in plasma after taking a dose of 4 g is 75 μg / ml. Metabolized in the liver. Easily penetrates through histohematic barriers and is distributed in tissues. High concentrations of the drug are found in the lungs, kidneys and liver. Moderately penetrates into the cerebrospinal fluid only with inflammation of the membranes, in this case, the concentration of aminosalicylic acid in the cerebrospinal fluid is 10-50% of the concentration of the drug in the blood plasma. It is excreted mainly in the urine (80% of the drug is excreted within 10 hours), with 50% in the form of an acetylated derivative. T 1/2 is 0.5 hours. Excretion is reduced in patients with impaired liver function.

Application for violations of kidney function

The drug is contraindicated in renal failure.

Dosing regimen

Inside, 0.5-1 hour after eating, drinking boiled water.

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

children

In the conditions of outpatient treatment, you can prescribe the entire daily dose in one dose.

special instructions

Used in combination with anti-tuberculosis drugs. During treatment, it is recommended to control the activity of hepatic transaminases.

Use in children

children appoint at the rate of 0.2 g / kg / day in 3-4 doses, the maximum dose is 10 g / day.

The drug is contraindicated in children under 3 years of age.

Side effect

Decreased appetite, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, hepatomegaly, increased liver transaminases, hyperbilirubinemia; proteinuria, hematuria, crystalluria. Rarely- thrombocytopenia, leukopenia (up to agranulocytosis), drug-induced hepatitis, B 12 deficiency megaloblastic anemia.

allergic reactions- fever, dermatitis (urticaria, purpura, enanthema), eosinophilia, arthralgia, bronchospasm.

At long-term use at high doses- hypothyroidism, goiter, myxedema.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

drug interaction

Producer: JSC "Chemical-Pharmaceutical Plant "AKRIKHIN" Russia

ATC code: J04AA01

Farm group:

Release form: Solid dosage forms. Tablets.

General characteristics. Compound:

Active substance: 1 g sodium aminosalicylate dihydrate.

Excipients: sorbitol, povidone (Kollidon 90 F), calcium stearate, talc, citric acid.

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

Pharmacological properties:

Pharmacodynamics.It has a bacteriostatic effect on Mycobacterium tuberculosis. Aminosalicylic acid competes with para-aminobenzoic acid and inhibits folate synthesis in mycobacteria. The drug is active against multiplying mycobacteria, has practically no effect on bacteria that are at rest or located intracellularly. Reduces the likelihood of developing resistance of mycobacteria to streptomycin and isoniazid.

Pharmacokinetics.Absorption is high. The maximum concentration in blood plasma after taking a dose of 4 g is 75 mcg / ml. Metabolized in the liver. Easily penetrates through histohematic barriers and is distributed in tissues. High concentrations of the drug are found in the lungs, kidneys and liver.

Moderately penetrates into the cerebrospinal fluid only with inflammation of the membranes, in this case, the concentration of aminosalicylic acid in the cerebrospinal fluid is 10-50% of the concentration of the drug in the blood plasma. It is excreted mainly in the 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 hours. Excretion is reduced in patients with impaired liver function.

Indications for use:

Tuberculosis (various forms and localizations) in complex therapy.

Dosage and administration:

Inside, 0.5-1 hour after eating, drinking boiled water.Adults - 9-12 g / day (3-4 g 3 times a day), for malnourished patients weighing less than 50 kg - 6 g / day.

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

In the conditions of outpatient treatment, you can prescribe the entire daily dose in one dose.

Application Features:

Used in combination with anti-tuberculosis drugs.

Decreased renal function against the background or a specific lesion is not a contraindication to the appointment. Development and require temporary discontinuation of the drug.

Side effects:

Decreased appetite, abdominal pain, or constipation, increased activity of "liver" transaminases, hyperbilirubinemia; proteinuria, hematuria, crystalluria.

Allergic reactions - fever, (urticaria, purpura, enanthema),.

With prolonged use in high doses -, goiter,.

Interaction with other drugs:

Compatible with other antituberculous drugs.

When combined with isoniazid, it increases its concentration in the blood.

Violates the absorption of rifampicin, erythromycin and lincomycin.

Violates the absorption of vitamin B12 (increases the risk of anemia).

anti-tuberculosis drug

Active substance

Release form, composition and packaging

Enteric coated tablets pink with a brownish tint, oval, biconvex; on a break - white with a creamy shade of color.

Excipients: sorbitol, (kollidon 90F), calcium stearate, talc, citric acid.

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

500 pcs. - polymeric containers.

pharmachologic effect

It has a bacteriostatic effect on Mycobacterium tuberculosis. competes with para-aminobenzoic acid and inhibits folate synthesis in Mycobacterium tuberculosis. The drug is active against multiplying mycobacteria, has practically no effect on bacteria that are at rest or located intracellularly. Reduces the likelihood of developing resistance of mycobacteria to and isoniazid.

Pharmacokinetics

Absorption is high. C max in plasma after taking a dose of 4 g is 75 μg / ml. Metabolized in the liver. Easily penetrates through histohematic barriers and is distributed in tissues. High concentrations of the drug are found in the lungs, kidneys and liver. Moderately penetrates into the cerebrospinal fluid only with inflammation of the membranes, in this case, the concentration of aminosalicylic acid in the cerebrospinal fluid is 10-50% of the concentration of the drug in the blood. It is excreted mainly in the urine (80% of the drug is excreted within 10 hours), with 50% in the form of an acetylated derivative. T 1/2 is 0.5 hours. 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 of the liver;

- amyloidosis of internal organs;

- peptic ulcer of the stomach and duodenum;

- enterocolitis (exacerbation);

- myxedema (uncompensated);

- jade;

- decompensated chronic insufficiency(including against the background of heart disease);

- thrombophlebitis;

- hypocoagulation;

- pregnancy;

- lactation;

- children's age up to 3 years.

Carefully with epilepsy.

Dosage

Inside, 0.5-1 hour after eating, drinking boiled water.

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

children appoint at the rate of 0.2 g / kg / day in 3-4 doses, the maximum dose is 10 g / day.

In the conditions of outpatient treatment, you can prescribe the entire daily dose in one dose.

Side effects

allergic reactions- fever, dermatitis (urticaria, purpura, enanthema), eosinophilia, arthralgia, bronchospasm.

At long-term use at high doses- hypothyroidism, goiter, myxedema.

drug interaction

special instructions

Used in combination with anti-tuberculosis drugs. During treatment, it is recommended to control the activity of hepatic transaminases.