Sodium para-aminosalicylate - instructions for use, dose, side effects, contraindications

Excipientslactose monohydrate 53.25 mg, povidone K-30 11.00 mg, aerosil 300 (silicon dioxide colloid) 11.00 mg, crospovidone 11.00 mg, calcium stearate 8.80 mg, citric acid monohydrate 4.95 mg.

Shell: film coating (methacrylic acid and ethyl acrylate copolymer [1: 1] 44,000 mg, talc 40.975 mg, titanium dioxide 16.500 mg, triethyl citrate 5.280 mg, silicon dioxide colloid 1.375 mg, sodium hydrogen carbonate 1.320 mg, sodium lauryl sulfate 0.550 mg) 110 mg.

Description:

Biconvex, oval tablets covered with enteric coating, white or almost white with a creamy hue of color, on the cross-section the nucleus is from white to light brown in color.

Pharmacotherapeutic group:Anti-tuberculosis drug

ATX: & nbsp

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

The antituberculous agent is the sodium salt of aminosalicylic acid. Para-aminosalicylic acid and its sodium salt have bacteriostatic activity against mycobacteria of tuberculosis and belong to the main anti-tuberculosis drugs.

Pharmacokinetics:

When administered orally, sodium para-aminosalicylate is well absorbed and enters the blood serum and tissues of the internal organs. Absorption is high; moderately penetrates into the cerebrospinal fluid (only with inflammation of the membranes). Easily penetrates through the histogematic barriers and is distributed in tissues. Communication with proteins 50-60%. Metabolised in the liver and partially in the stomach. T1 / 2 - 0.5-1 h.80% is excreted by the kidneys by glomerular filtration (50% in the form of an acetylated derivative). The total clearance depends on both the metabolic rate and the excretion of the kidneys.

Indications:

Tuberculosis (various forms and localizations) in combination with other antituberculous drugs.

Contraindications:

Renal / hepatic insufficiency, decompensated CHF, peptic ulcer and duodenal ulcer, epilepsy, enterocolitis (exacerbation), myxedema (exacerbation), lactation period, hypersensitivity to aminosalicylic acid and its salts and to drug auxiliaries, lactase deficiency, intolerance to galactose, glucose-galactose malabsorption.

Children up to 12 years old.

Carefully:

Pregnancy, moderately expressed hepatic insufficiency, deficiency of glucose-6-phosphate dehydrogenase, compensated hypothyroidism.

Dosing and Administration:

The drug is taken orally within 1 / 2-1 hour after meals, washed down with milk, alkaline mineral water, 0.5-2% sodium bicarbonate solution.

Adults - 9-12 g / day in 3-4 hours; a malnourished adult patient (with a body weight of less than 50 kg) - 6 g / day in 3-4 doses.

For children - 0.2 g / kg / day in 3-4 hours, the maximum dose of 10 g / day.

Side effects:

From the digestive system: decreased or loss of appetite, increased salivation, nausea, vomiting, flatulence, abdominal pain, diarrhea, or constipation; rise activity of "liver" transaminases, hyperbilirubinemia, jaundice; rarely - drug-induced hepatitis (including fatal).

From the hematopoiesis: rarely - thrombocytopenia, leukopenia (up to agranulocytosis), B 12-deficiency anemia, hemolytic anemia with a positive breakdown of Coombs.

From the genitourinary system: proteinuria, hematuria, crystalluria.

Allergic reactions: Rash (hives, purpura, enanthema, exfoliative dermatitis, a syndrome that resembles an infectious mononucleosis or lymphoma), fever, bronchospasm, arthralgia, eosinophilia.

Other: in large doses - antithyroid effect; with prolonged use - zobogenous effect, drug hypothyrosis, myxedema; pericarditis, hypoglycemia, optic neuritis, encephalopathy, Leffler's syndrome (eosinophilic pneumonia, migratory pulmonary infiltrate), vasculitis, decreased prothrombin.

Overdose:

Symptoms: may increase dose-related side effects.

Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

Compatible with other antituberculous drugs.

Slows the emergence of resistance to isoniazid and streptomycin.

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

Violates the absorption of rifampicin, erythromycin and lincomycin.

Disrupts the assimilation of cyanocobalamin (possible development of 12-deficiency anemia).

Antacids do not interfere with drug absorption.

Strengthens the effect of indirect anticoagulants - derivatives of coumarin and indanedione (correction of the dose of anticoagulants is required).

When using iodine-containing hormones of the thyroid gland, their analogs and antagonists (including antithyroid drugs), it should be taken into account that the concentration of T4 and TSH in the blood changes in the background of PABA.

Ammonium chloride increases the risk of developing crystalluria.

Simultaneous administration with ethionamide increases the risk of hepatotoxicity.

Diphenhydramine reduces the effectiveness of aminosalicylic acid.

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

Special instructions:

Used in combination with more active 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, 1000 mg.

Packaging:

For 500 tablets per package of polyethylene film. The plastic bag together with the instruction for use is packed in a polymer jar with a screw cap. 8 cans are placed in a group package.

Storage conditions:

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:For hospitals

Registration number:LSR-008139/10

Date of registration:16.08.2010 / 26.11.2015

Expiration Date:Unlimited

The owner of the registration certificate:HEALTH OF CNT, CJSC HEALTH OF CNT, CJSC Russia

Manufacturer: & nbsp

RAFARMA, JSC Russia

Information update date: & nbsp25.05.2018

Illustrated instructions

Instructions

Sodium para-aminosalicylate (Sodium para-aminosalicylate)