Composition, form of production and packaging
Tablets covered with an enteric-coated pink coat with a brownish hue, oval, biconvex; on a break - white with a creamy shade of color.
1 tab.
sodium para-aminosalicylate 1 g
Excipients: sorbitol, povidone (kollidon 90F), calcium stearate, talc, citric acid.
Composition of the shell: ready-made mixture "ACRYL-IZ" (copolymer of methacrylic acid with ethyl acrylate (1: 1), titanium dioxide, talc, triethyl citrate, silicon dioxide colloidal anhydrous, sodium bicarbonate, sodium lauryl sulfate), iron oxide, red oxide, iron oxide , simethicone emulsion 30%.
500 pcs. - Polymer containers.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Has a bacteriostatic effect on Mycobacterium tuberculosis. Aminosalicylic acid competes with para-aminobenzoic 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. C max in blood plasma after taking a dose of 4 g is 75 mcg / 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 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 with 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 h. Excretion is reduced in patients with impaired liver function.
INDICATIONS
- tuberculosis (various forms and localizations) in complex therapy.
DOSING MODE
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 EFFECT
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 - deficiency megaloblastic anemia.
Allergic reactions - fever, dermatitis (urticaria, purpura, enanthema), eosinophilia, arthralgia, bronchospasm.
With prolonged use in high doses - hypothyroidism, goiter, myxedema.
CONTRAINDICATIONS
hypersensitivity;
- kidney failure;
- liver failure;
- Hepatitis;
- cirrhosis of the liver;
- amyloidosis of internal organs;
- Stomach ulcer and duodenal ulcer;
- enterocolitis (exacerbation);
- Myxedema (uncompensated);
- nephrite;
- decompensated chronic heart failure (including on a background of heart disease);
- thrombophlebitis;
- hypocoagulation;
- Pregnancy;
- lactation;
- Children under 3 years old.
With caution in epilepsy.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in case of liver failure.
APPLICATION FOR CHILDREN
Children are prescribed at a rate of 0.2 g / kg / day in 3-4 divided doses, the maximum dose is 10 g / day.
The drug is contraindicated for children under 3 years.
SPECIAL INSTRUCTIONS
Used in combination with antituberculous drugs. In the treatment it is recommended to monitor the activity of hepatic 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.
DRUG INTERACTION
Compatible with other antituberculous drugs. When combined with isoniazid increases its concentration in the blood. Violates the absorption of rifampicin, erythromycin and lincomycin. Violates the absorption of vitamin B 12 (increases the risk of anemia).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children
Shelf life 3 years. Do not use after expiry date.
