PASK - instructions for use, dose, side effects, contraindications

Kernel: Microcrystalline cellulose 10 mg / 20 mg, magnesium hydroxycarbonate 10 mg / 20 mg, povidone medium-molecular 14 mg / 28 mg, stearic acid 1 mg / 2 mg, aerosil (silicon dioxide colloid) 2 mg / 4 mg, crospovidone ) 3 mg / 6 mg. Sheath: "Advantia Performens", firm "IPS", lot 390076HZ49, Switzerland 60 mg / 120 mg (Composition of the shell: methacrylic acid and ethyl acrylate copolymer 32.52 mg / 65.04 mg, macrogol 6000 (polyethylene glycol 6000) 1 , 5 mg / 3 mg, talc 15 mg / 30 mg, triethyl citrate 7.02 mg / 14.04 mg, titanium dioxide 3.96 mg (7.92 mg)

Description:tablets without risks (500 mg) and with a risk (1000 mg), film-coated, oval, white

Pharmacotherapeutic group:anti-tuberculosis drug

ATX: & nbsp

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

PASK® (sodium para-aminosalicylate) has bacteriostatic action against Mycobacterium tuberculosis. It reduces the likelihood of development 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. PASK 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. Active only with respect to Mycobacterium tuberculosis.

Pharmacokinetics:

Well absorbed when taken orally. Easily passes through the histohematological barriers and is distributed along the tissues. The maximum concentration in the blood serum, after ingestion of the dose of 4g is 75 μg / ml.

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

Indications:

PASK® It is used to treat various forms and localizations of tuberculosis in combination with other anti-tuberculosis drugs. More often PASK® prescribe to patients with multiple drug resistance to other anti-tuberculosis drugs.

Contraindications:

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

Carefully:Epilepsy

Pregnancy and lactation:

It is possible to use PASK® during pregnancy in the event that the expected benefit for the mother exceeds the potential risk to the fetus.

If you need to use PASK®, lactation should stop breastfeeding.

Dosing and Administration:

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 emaciated patients with a body weight of 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 - 10 g / day.

In an outpatient setting, the entire daily dose can be administered in a single dose.

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

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-deficient 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 antituberculous drugs. When combined with isoniazid increases its concentration in the blood. Violates the absorption of rifampicin, erythromycin and lincomycin. It interferes with the absorption of vitamin B12 (the risk of anemia increases).

Special instructions:

Apply in combination with anti-tuberculosis 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 an enteric coating containing an active ingredient of 500 mg or 1000 mg.

Packaging:

For 50, 100, 372 or 500 tablets (for hospitals) in a jar of polypropylene or low-density polyethylene with a lid of polypropylene or high-density polyethylene, or a can of polyethylene terephthalate with a screw cap. The space free from tablets is filled with cotton wool.

On the bank stick a label from paper label or writing on or a self-adhesive label. Banks, together with 15 instructions for use, are placed in a group container.

Storage conditions:

Store at a temperature not exceeding 25 ° C, in a dry, dark place out of the reach of children.

Shelf life:4 years.
Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007579/08

Date of registration:19.09.2008

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

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Information update date: & nbsp01.09.2014

Illustrated instructions

Instructions

PASK® (PASK®)