Universal reference book for medicines
Name of the preparation: PAS-FATOL H (PAS-FATOL N)

Active substance: aminosalicylic acid

Type: Anti-TB drug

Manufacturer: RIEMSER ARZNEIMITTEL (Germany) manufactured by THYMOORGAN PHARMAZIE (Germany) packed FATOL ARZNEIMITTEL subsidiary of RIEMSER ARZNEIMITTEL (Germany) promotion on the territory of the Russian Federation SVCHICH (Russia)
Lyophilizate for the preparation of a solution for infusions in powder form from white to light gray.
1 f.

sodium para-aminosalicylate 13.49 g,

which corresponds to the content of para-aminosalicylic acid 11.72 g

Na + 1.77 g

Vials of transparent glass with a capacity of 500 ml (type 1, hydrolytic class 1) in wrapping light-protective paper (10) complete with transflo (10 pcs.) - cardboard boxes (for hospitals).

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Anti-tuberculosis drug.
Aminosalicylic acid (para-aminosalicylic acid, PASK) has a bacteriostatic effect on Mycobacterium tuberculosis. 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 Mycobacterium tuberculosis.
Aminosalicylic acid 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.

Aminosalicylic acid is active only against Mycobacterium tuberculosis.
It acts on non-tuberculous mycobacteria.
PHARMACOKINETICS

Distribution

Binding to plasma proteins is 50-60%.

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

Metabolism and excretion

Metabolised in the liver and partially in the stomach.

80% of aminosalicylic acid is excreted in the urine, with more than 50% being excreted in the acetylated form.
The process of acetylation is not genetically determined (as is the case with isoniazid).
Aminosalicylic acid is excreted by glomerular filtration.

Features of the clinical pharmacology of aminosalicylic acid is the rapid formation in the acid medium of a toxic inactive metabolite and a short T 1/2 of blood plasma, which for an unbound drug is 1 h.

INDICATIONS

- tuberculosis of different localization (as part of complex therapy with other anti-TB drugs), most often with multiple drug resistance to other anti-tuberculosis drugs.

DOSING MODE

Adults and children over 14 years of age, the drug is prescribed in a dose of 10-15 g / day.

For preterm infants, infants, infants and children under 6 years of age, the daily dose is usually 200-300 mg / kg body weight.

The drug is administered IV infusion for 2-4 hours. To prepare the infusion solution, the drug is dissolved in 500 ml of water for injection.

If it is necessary to prolong the administration, it is recommended to maintain the electrolyte balance: the appointment of potassium salt inside or the addition of a certain amount of the appropriate potassium preparation for infusions in the infusion solution, based on the preliminary assessment of the potassium content in the blood plasma.

SIDE EFFECT

On the part of the digestive system: often - excessive salivation, nausea, vomiting, worsening or loss of appetite, abdominal pain, diarrhea, flatulence, constipation;rarely - a moderate transient increase in transaminase activity, sometimes accompanied by jaundice.
Approximately 25% of patients with an allergic reaction to PASC have liver damage, and in 10% of cases it can lead to liver failure and death.
Allergic reactions: fever, dermatitis such as urticaria or purpura, enanthema, asthmatic phenomena, pain in the joints, eosinophilia, rarely - agranulocytosis, leukopenia, thrombocytopenia, drug-induced hepatitis.
Allergic reactions may appear in a few days, although they mostly occur between 2-7 weeks of treatment (most often at 4-5 weeks). Occasionally, side effects such as severe allergic reactions (eg, Quincke's edema), swelling of the joints, fever caused by the administration of drugs, reactions similar to lupus erythematosus, accompanied by lesions of the spleen, liver, kidneys, digestive tract, bone marrow and nervous system for example, pain of radicular nature, meningism, multi-form exudative erythema in the form of Stevens-Johnson syndrome or Lyell syndrome).
From the hemopoietic system: rarely - an increase in prothrombin time, accompanied by bleeding, and in exceptional cases - hemorrhagic rash.

From the urinary system: from rare to frequent cases - a moderate transient microhematuria, albuminuria and cylindruria;
it is possible to increase the level of urea in the blood, indicating the presence of uremic reaction, especially in patients with impaired renal function and acidosis.
On the part of the endocrine system: often, especially with prolonged use in high doses, - deterioration of the thyroid gland, accompanied by the appearance of goiter.

From the side of metabolism: rarely expressed violations of the electrolyte balance, mainly hypokalemia when the drug is administered in high doses (especially in elderly patients with edema and hypertension, as well as in patients suffering from meningitis), normoglycemic or hyperglycemic glucosuria;
when administered in high doses, acidosis is possible due to the loss of cations (most often in children).
On the part of the respiratory system: in some cases - a temporary (including allergic) infiltration in the lungs (Leffler's syndrome).

From the side of the central nervous system: in some cases - the symptoms of paralysis, clonic-tonic convulsions, as well as psychosis.

Other: with prolonged use at maximum doses - superinfection.

CONTRAINDICATIONS

- impaired renal function;

- impaired liver function;

- heart failure in the stage of decompensation;

- Stomach ulcer and duodenal ulcer;

- epilepsy;

- enterocolitis in the phase of exacerbation;

- Myxedema in the phase of exacerbation;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

If you need to use the drug during pregnancy and lactation (breastfeeding), you should correlate the intended benefit to the mother and the potential risk to the fetus and the baby.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is contraindicated for use.
if the kidney function is impaired.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated for use.
with a violation of the liver.
SPECIAL INSTRUCTIONS

During treatment, it is necessary to regularly perform blood and urine tests, to monitor liver function.

To prevent crystalluria, measures should be taken to maintain the alkaline pH of the urine, especially if it has an acidic reaction.

In case of violations of the liver or kidney function, diabetes, ulcerative lesions of the gastrointestinal tract, the dose of the drug should be carefully set and the patient's condition should be monitored regularly during the treatment.

On the background of therapy, false-positive results are possible with non-enzymatic determination of glucose and urobilinogen in the urine.

Impact on the ability to drive vehicles and manage mechanisms

To date, there is no evidence of the undesirable effects of PASK on the ability to drive vehicles or work with machinery.

OVERDOSE

Symptoms: anaphylactic shock is possible.

Treatment: immediately stop the drug and begin anti-shock therapy (administration of antihistamines, corticosteroids, sympathomimetics, artificial respiration).

In case of poisoning, the drug should be discontinued, if necessary - hemodialysis.

DRUG INTERACTION

PASC disrupts the absorption of rifampicin, erythromycin and lincomycin.

PASK disrupts the absorption of vitamin B 12 , and as a result, anemia may develop.

The use of PASC concurrently with isoniazid or phenytoin leads to an increase in the duration of isoniazid or phenytoin in the blood plasma.

With the simultaneous use of PASC with salicylates, phenylbutazone or other anti-inflammatory drugs with an increased ability to bind proteins, leads to an increase in the concentration and increase in the duration of PAS in the blood plasma.

When using PASC simultaneously with diphenylhydramine leads to a decrease in the concentration of PASC in the blood plasma.

PASK inhibits folate absorption and may increase the toxicity of folate antagonists, such as methotrexate.

Pharmaceutical incompatibility

PASK should not be administered in a single solution with rifampicin and protionamide.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, protected from light, at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
Ready-to-use solution should be used immediately after its preparation.

The information is provided for your information, do not self-medicate, it is dangerous for your health.

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