Sodium para-aminosalicylate - instructions for use, dosage, adverse effects, contraindications

Sodium para-aminosalicylate (abbreviated as PASK) has a bacteriostatic effect against Mycobacterium tuberculosis. It reduces the likelihood of bacterial resistance to streptomycin and isoniazid, the mechanism of action is associated with inhibition of the synthesis of folic acid and with the suppression of the formation of mycobacterium, a component of the mycobacterial wall, which leads to a decrease in the capture of iron M. tuberculosis.

Sodium para-aminosalicylate acts on mycobacteria, which are in a state of active reproduction, and practically does not affect the mycobacteria at rest. Slightly affects the pathogen, located intracellularly.

Sodium para-aminosalicylate is active only in relation to M. tuberculosis.

Pharmacokinetics:

Well absorbed when taken orally. The maximum concentration in the blood serum, after ingestion of a dose of 4 g is 75 μg / ml.

Metabolised in the liver. Sodium para-aminosalicylate is excreted by glomerular filtration.80% of the drug is excreted in the urine, and more than 50% is excreted in the acetylated form. In the cerebrospinal fluid the drug penetrates only with inflammation of the meninges.

Indications:Sodium para-aminosalicylate (PASK) is indicated for the treatment of various forms and localizations of tuberculosis in combination with other anti-tuberculosis drugs. More often PASC is prescribed to patients with multiple drug resistance to other anti-TB drugs.

Contraindications:

- Individual intolerance to the drug;

- Severe kidney and liver disease;

- Heart failure in the stage of decompensation;

- Stomach ulcer and duodenal ulcer;

- Enterocolitis in the phase of exacerbation;

- Myxedema in the phase of exacerbation.

Pregnancy and lactation:

Possible use of the drug PASK in pregnancy in the event that the expected benefit for the mother exceeds the potential risk to the fetus.

If you need to use the drug PASK during lactation should stop breastfeeding.

Dosing and Administration:

Assign PASK inside in the form of granules - adults at 0.2 g / kg body weight (no more than 12.0 grams per day) for 2-3 doses;

children are prescribed 0.2 g / kg body weight (not more than 8.0 grams per day) for 2-3 doses.

Granules should be taken after meals, washed down with water.

In an outpatient setting, the entire daily dose can be given in a single dose, but with a bad tolerance, the daily dose is divided into 2 doses.

Side effects:

The most common side effects from the gastrointestinal tract are nausea, vomiting, worsening or loss of appetite, abdominal pain, diarrhea, or constipation.

Allergic reactions: fever, dermatitis such as urticaria or purpura, enantema, bronchospasm, joint pain, eosinophilia, rarely agranulocytosis, leukopenia, thrombocytopenia, drug-induced hepatitis.

Crystalluria can be prevented by maintaining a neutral or alkaline pH value of urine. With prolonged use in higher doses - hypothyroidism, goiter.

Interaction:

PASK increases the concentration of isoniazid in the blood.

PASC disrupts the absorption of rifampicin, erythromycin and lincomycin.

PASK disrupts the absorption of vitamin B₁₂, resulting in the development of anemia.

PASC can enhance the action of anticoagulants (coumarin or indanedione derivatives). Antacids do not interfere with the absorption of PASC.

Special instructions:

At the first sign indicating an allergic reaction, the drug should be immediately discontinued and desensitizing therapy should be performed.

During the treatment, it is necessary to systematically examine urine and blood and check the functional state of the liver.

Form release / dosage:

Granules coated with enteric coating, 800 mg / g.

Packaging:

By 3.8 g or 4 g or 5 g in a package heat-sealing of buffered or foil laminated. 1 or 10 bags together with instructions for use are placed in a pack of cardboard.

50 or 100 packets together with 10 instructions for use are placed in a cardboard box.

100 grams in a plastic bag, the package is sealed, placed together with the instructions for use and a measuring spoon for 4 grams in a pack of cardboard.

Packs and cardboard boxes are placed in a group package.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N001475 / 01

Date of registration:15.12.2008 / 19.05.2016

Expiration Date:Unlimited

The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Information update date: & nbsp25.05.2018

Illustrated instructions

Instructions

Sodium para-aminosalicylate (Sodium para-aminosalicylate)