Monopas - instructions for use, doses, side effects, contraindications

Core: microcrystalline cellulose - 186.5 mg, sucrose (sugar) - 84.5 mg, povidone-K25 (medium molecular weight polyvinylpyrrolidone, collidon 25) - 39.0 mg,

Sheath: cellacephate (acetylphthalyl cellulose) 50.0 mg, shellac 26.0 mg, macrogol 6000 (polyethylene glycol 6000) 1.0 mg, castor oil 63 mg, paraffin liquid (vaseline oil) 5.2 mg, magnesium hydrosilicate ( talc) -1.0 mg, iron dye red oxide-0.5 mg.

Description:

Granules coated with enteric-coated shell, from red to red-brown color, round shape.

Pharmacotherapeutic group:Anti-tuberculosis drug

ATX: & nbsp

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

Aminosalicylic acid has a bacteriostatic effect against Mycobacterium tuberculosis. It reduces the likelihood of bacterial resistance to streptomycin and isoniazid. Mechanism of action: aminosalicylic acid competes with para-aminobenzoic acid (PABA) and suppresses the synthesis of folic acid in mycobacteria tuberculosis, inhibits the formation of mycobacterium, a component of the mycobacterial wall, which leads to a decrease in the capture of iron M. tuberculosis.

Aminosalicylic acid acts on the mycobacteria that are in the active state propagation, and virtually no effect on Mycobacterium in the resting stage.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 oral administration of a dose of 4 g is 75 μg / ml.

Metabolised in the liver. Aminosalicylic acid is derived by glomerular filtration. 80 % The drug is excreted in the urine, with more than 50% excreted in the acetylated form. AT spinal fluid drug penetrates only with inflammation of the meninges.

Indications:

Aminosalicylic acid is used to treat various forms and localizations of tuberculosis in combination with other anti-tuberculosis drugs. More often aminosalicylic acid prescribe 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; peptic ulcer of the stomach and duodenum; enterocolitis in the exacerbation phase; Myxedema in the phase of exacerbation;thrombophlebitis; impaired blood clotting; lactation period.

Carefully:

Renal and / or liver failure; in the anamnesis - gastric bleeding.

Pregnancy and lactation:

Possible use of aminosalicylic acid during pregnancy in that case, when the expected benefit for the mother exceeds the potential risk to the fetus.

If you need to use aminosalicylic acid during lactation, breastfeeding should be stopped.

Dosing and Administration:

Inside, 0.5-1 hour after meals, washed down with water or milk, alkaline mineral water, a weak (0.5-2%) sodium bicarbonate solution.

Adults - 9-12 g / day in 2-3 sessions; for malnourished patients with a body weight of less than 50 kg - 6 g / day.

Children appoint at the rate of 0.2 g / kg / day in 1-2 divided doses, not more than 8 g / day.

In conditions of outpatient treatment, the whole daily dose can be prescribed for one dose (in case of good tolerability).

Side effects:

Decreased appetite, excessive salivation, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, hyperbilirubinemia, increased activity of "hepatic" transaminases, proteinuria, hematuria, crystalluria.

Rarely - thrombocytopenia, leukopenia (up to agranulocytosis), drug-induced hepatitis, incl. with lethal outcome, in 12-deficient megaloblastic anemia.

Allergic reactions - fever, dermatitis (urticaria, purpura, enanthema), eosinophilia, arthralgia, bronchospasm.

With prolonged use in high doses - hypothyroidism, goiter, myxedema.

Interaction:

Aminosalicylic acid increases the concentration of isoniazid in the blood. Aminosalicylic acid disturbs the absorption of rifampicin, erythromycin and lincomycin.

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

Aminosalicylic acid can enhance the effect of anticoagulants (coumarin or indanedione derivatives).

Antacids do not interfere with the absorption of aminosalicylic acid.

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:

Granules coated with enteric coating 600 mg / g.

Packaging:

4 g; 5 g; 5.34 g; 5.52 g; 6.67 g; 6.7 g; 8.34 g or 9.2 grams in a bag heat-sealable from boufflen or foil laminated. 1 or 10 bags together with instructions for use in a pack of cardboard.

For 25, 50 or 100 bags (for hospitals) together with 10 instructions for use in a cardboard box.

100 grams per package of polyethylene film. The package is hermetically sealed and, together with the instruction for use and a measuring spoon made of polypropylene, is placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Shelf life:

3 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002473/10

Date of registration:26.03.2010 / 24.10.2016

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: & nbsp02.06.2018

Illustrated instructions

Instructions

Monopas® (Monopas®)