Universal reference book for medicines
Product name: SODIUM PARA-AMINOSALICYLATE (SODIUM PARA-AMINOSALICYLATE)

Active ingredient: aminosalicylate sodium

Type: Anti-TB drug

Producer: ZiO-Zdorovye (Russia)
Composition, form of production and packaging
Tablets, covered with enteric coating
1 tab.

sodium para-aminosalicylate 1 g

50 pcs.
- polymer cans (1) - packs of cardboard.
100 pieces.
- polymer cans (1) - packs of cardboard.
500 pcs.
- polyethylene bags (1) - polymer containers.
1000 pcs.
- polyethylene bags (1) - polymer containers.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

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.Binding to proteins - 50-60%. Metabolised in the liver and partially in the stomach. T 1/2 - 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 anti-tuberculosis drugs.

DOSING MODE

The drug is taken inside 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 EFFECT

On the part of the digestive system: decreased or loss of appetite, increased salivation, nausea, vomiting, flatulence, abdominal pain, diarrhea, or constipation;increased activity of hepatic transaminases, hyperbilirubinemia, jaundice;
rarely - drug-induced hepatitis (including fatal).
On the part of the organs of 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 (urticaria, purpura, enanthema, exfoliative dermatitis, a syndrome resembling 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.
CONTRAINDICATIONS

renal / hepatic insufficiency;

Decompensated chronic heart failure;

- Stomach ulcer and duodenal ulcer;

- epilepsy;

- enterocolitis (exacerbation);

- Myxedema (exacerbation);

- lactation period;

- children under 12 years;

- Hypersensitivity to aminosalicylic acid and its salts and to the excipients of the drug.

With caution: pregnancy, moderately expressed hepatic insufficiency, deficiency of glucose-6-phosphate dehydrogenase, compensated hypothyroidism.

PREGNANCY AND LACTATION

With caution apply the drug during pregnancy.

Contraindicated during lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Decreased kidney function against tuberculous intoxication or specific damage is not a contraindication to the appointment.

Contraindicated in renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in liver failure.

Carefully:
moderately expressed hepatic insufficiency. In the treatment it is recommended to monitor the activity of hepatic transaminases.
APPLICATION FOR CHILDREN

Contraindicated in children under 12 years.

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

SPECIAL INSTRUCTIONS

Used in combination with more active 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.

OVERDOSE

Symptoms: may increase dose-related side effects.

Treatment: withdrawal of the drug, symptomatic therapy.

DRUG 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 B 12- deficient 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 agents), 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.

TERMS OF RELEASE FROM PHARMACY

For hospitals.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 2 years. Do not use after expiration date
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