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medicalmeds.eu Medicines Antituberculous remedy. Monopass

Monopass

Препарат Монопас. ОАО "Фармасинтез" Россия


Producer: JSC Pharmasintez Russia

Code of automatic telephone exchange: J04AA01

Release form: Firm dosage forms. Granules.

Indications to use: Tuberculosis.


General characteristics. Structure:

Active ingredient: 600,0 mg of sodium of para-aminosalicylate of a dihydrate on 1 g of a dosage form.

Antitubercular lekartsvenny drug.




Pharmacological properties:

Pharmacodynamics. Sodium para-aminosalicylate possesses bacteriostatic action concerning Mycobacterium tuberculosis. It reduces probability of development of bacterial resistance to streptomycin and an isoniazid, the mechanism of action is connected with oppression of synthesis of folic acid and with suppression of formation of a mikobaktin, component of a mikobakterialny wall that leads to reduction of capture of M. tuberculosis iron. Sodium para-aminosalicylate affects the mycobacteria which are in a condition of active reproduction and practically does not act on a mycobacterium in a rest stage. Poorly influences on the activator which is located intracellularly. It is active only concerning Mycobacterium tuberculosis.

Pharmacokinetics. It is well soaked up at intake. Easily passes through gistogematichesky barriers and it is distributed on fabrics. The maximum concentration in blood serum after intake of a dose of 4 g makes 75 mkg/ml. It is metabolized in a liver. Sodium para-aminosalicylate is removed by means of glomerular filtering. 80% of drug are excreted with urine, and more than 50% are removed in an acetylized form. Drug gets into cerebrospinal fluid only at an inflammation of a meninx.


Indications to use:

Sodium para-aminosalicylate is applied to treatment of various forms and localizations of tuberculosis in a complex with other antitubercular drugs. More often than sodium para-aminosalicylate is appointed to patients with multiple medicinal resistance to other antitubercular drugs.


Route of administration and doses:

Appoint sodium para-aminosalicylate inside of adult 2.0 g / 10 kg (7-14 g of active agent). Bags 4.0 grams on 2 bags 1-3 times, bags 6.7 grams on 1 bag 2-3 times a day. To children – on 0.2 g/kg a day in 3-4 receptions (a daily dose no more than 8 g of active agent): bags on 4.0 grams on 1-2 bags 1-2 times a day, bags 6.7 grams on 1 bag 1-2 times a day. Accept through 0,5-1ch after food, wash down with water. The exhausted adult patient (weighing body less than 50 kg), and also at bad portability no more than 6 g a day give drug in a dose. The daily dose is established taking into account the body weight of the patient, to accept in 2-3 receptions. In out-patient practice it is possible to appoint all daily dose in 1 reception.


Features of use:

It is necessary to be careful at patients with moderately expressed digestive tract pathology. At the first signs indicating allergic reaction, administration of drug has to be the desensibilizing therapy is immediately stopped and is carried out. In the course of treatment it is necessary to investigate systematically urine and blood and to check a functional condition of a liver.


Side effects:

The most frequent side effects from digestive tract are nausea, vomiting, deterioration or loss of appetite, an abdominal pain, a diarrhea or a lock. Allergic reactions: fever, dermatitis like small tortoiseshell or a purpura, an enantema, a bronchospasm, joint pains, an eosinophilia, seldom an agranulocytosis, a leukopenia, thrombocytopenia, medicamentous hepatitis. The crystalluria can be prevented by maintenance of the neutral or alkaline PH level of urine. At long reception in the highest doses a hypothyroidism, a craw, a diabetes mellitus.


Interaction with other medicines:

Sodium para-aminosalicylate increases concentration of an isoniazid in blood. Sodium para-aminosalicylate breaks absorption of rifampicin, erythromycin and lincomycin. Sodium of steam-aminosalttstlat breaks digestion of B12 vitamin owing to what development of anemia is possible. Sodium para-aminosalicylate can strengthen effect of anticoagulants (derivatives of coumarin or an indandion). Antiacid means do not break para-aminosalicylate sodium drug absorption.


Contraindications:

Individual intolerance of drug; serious illness of kidneys and liver; heart failure in a decompensation stage; peptic ulcer of a stomach and duodenum; a coloenteritis in an aggravation phase; a myxedema in an aggravation phase; thrombophlebitises; disturbance of coagulability of blood; pregnancy and period of a lactation. Para-aminosalicylate sodium drug use at pregnancy in that case when the expected advantage for mother exceeds potential risk for a fruit is possible. In need of para-aminosalicylate sodium drug use in the period of a lactation it is necessary to stop breastfeeding.



Storage conditions:

In the dry place, not available to children, at a temperature not above 25 °C.


Issue conditions:

According to the recipe


Packaging:

The granules covered with a kishechnorastvorimy cover. On 4 g or 6,7 g in the bag thermowelded from a buflen or the foil laminated. On 1 or 10 bags together with the application instruction place in a pack from a cardboard. On 50 or 100 bags (for hospitals) together with 10 application instructions in a box from a cardboard. On 100 g in a package from a film polyethylene. The package is hermetically soldered and together with the application instruction and a measured spoon on 4 and 6,7 g placed in a pack from a cardboard.



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