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

Description:White with yellow-brown shade of granules having an average diameter of 1.5 mm and by weight containing an average of 60% aminosalicylic acid.

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, the mechanism of action is associated with the 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.

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. Aminosalicylic acid is active only with respect to M.tuberculosis. Does not affect other non-tuberculosis mycobacteria.

Features of the clinical pharmacology of aminosalicylic acid is the rapid formation of a toxic inactive metabolite in an acid medium and a short period half-life in serum, which is one hour for unbound medication. Since the granules of the PASER preparation are protected by an enteric-soluble membrane, their absorption does not begin until they reach the small intestine.

Pharmacokinetics:

Well absorbed when taken orally. When healthy volunteers received 4 grams of the drug with food, the time to reach a therapeutic concentration of 6 hours (varied from 1.5 to 24 hours); the average maximum concentration is 20 μg / ml, varying in the range from 9 to 35 μg / ml; concentration of 2 μg / ml is saved on average 7.9 (from 5 to 9 hours); the concentration of 1 μg / ml is maintained on average 8.8 hours (from 6 to 11.5 hours). Metabolised in the liver and partially in the stomach. 80% of aminosalicylic acid is excreted in urine, and more than 50% is excreted in acetylated form. The process of acetylation is not genetically determined, as is the case with isoniazid. Aminosalicylic acid is derived by glomerular filtration.

In the cerebrospinal fluid the drug penetrates only with inflammation of the meninges.

About 50 - 60% of aminosalicylic acid binds to proteins.

Indications:

Aminosalicylic acid is indicated for the treatment of various forms and localizations of tuberculosis in combination with other antituberculous drugs. Most often it is prescribed to patients with multiple drug resistance to other anti-tuberculosis drugs.

Contraindications:

-Individual intolerance of the drug;

-Heavy kidney and liver diseases;

- Cardiac insufficiency in the stage of decompensation;

- Stomach ulcer and duodenal ulcer;

-Epilepsy;

- Enterocolitis in the phase of exacerbation;

-Miksedema in the phase of aggravation.

Pregnancy and lactation:

Possible use of the drug PAZER during 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 PAZER during lactation should stop breastfeeding.

Dosing and Administration:

Assign PAZER inside in the form of granules - adults 9-12 g per day (3-4 g Zraza per day).

Children are prescribed 0.2 g / kg body weight per day in 3-4 doses (daily dose no more than South).

Granules should be taken after meals, washed down with acid solutions (juices: orange, tomato, apple.)

Granules do not chew!

Side effects:

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

Allergic reactions: fever, dermatitis such as urticaria or purpura, enanthema, asthmatic phenomena, joint swelling, 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:

PAZER increases the concentration of isoniazid in the blood.

PASER breaks the suction rifampicin erythromycin and lincomycin.

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

Antacids do not interfere with the absorption of the drug PAZER.

Special instructions:

At the first sign, indicating an allergic reaction, taking all medications should be immediately stopped and desensitizing therapy performed.

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

Edit Warnings

Soft shells of granules can be seen in the stool.

Form release / dosage:

Granules of sustained release for oral administration.

Packaging:For 6.48 g of the drug in a bag of aluminum foil; the bag is sealed. For 30 bags with 1 instruction for use put in a cardboard box.

Storage conditions:

Store at temperatures below 15 ° C (can be stored in the refrigerator or freezer) in places inaccessible to children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014464 / 01-2002

Date of registration:18.02.2009

The owner of the registration certificate:Jacobus Pharmaceutical Company Inc.Jacobus Pharmaceutical Company Inc. USA

Manufacturer: & nbsp

JACOBUS PHARMACEUTICAL COMPANY, Inc. USA

Representation: & nbspSharan Pharma, LLCSharan Pharma, LLC

Information update date: & nbsp20.01.2014

Illustrated instructions

Instructions

Pasers (Paser)