Pyrazinamide-Acry - instructions for use, dose, side effects, contraindications

Composition:One tablet contains:
active substance: pyrazinamide in terms of 100% substance - 500 mg and
Excipients: potato starch, stearic acid, sodium carboxymethyl starch (sodium starch glycolate).

Description:Tablets are white or almost white in color, flat-cylindrical, with a facet and a risk.

Pharmacotherapeutic group:Anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K.01 Pyrazinamide

Pharmacodynamics:Anti-tuberculosis drug. It acts on intracellularly located mycobacteria, it penetrates well into the centers of tuberculous lesion. More effective in an acidic environment.
Depending on the dose, it has a bactericidal or bacteriostatic effect.
In the course of treatment, the development of resistance is possible, the probability of which decreases when combined with other antituberculous drugs.

Pharmacokinetics:Quickly and completely absorbed in the gastrointestinal tract. The connection with plasma proteins is 10 - 20%. The maximum concentration of the drug in the blood plasma is reached in 1-2 hours. It penetrates well into tissues and organs. Metabolised in the liver, where an active metabolite, pyrazinic acid, is first formed, which is then converted into an inactive metabolite, 5-hydroxypyrazinic acid.
The half-life of the drug is 8-9 hours. It is excreted by the kidneys: in unchanged form - 3%, in the form of pyrazinic acid - 33%, in the form of other metabolites - 36%, Removed during hemodialysis.

Indications:Tuberculosis.

Contraindications:Hypersensitivity, pregnancy, lactation, children under 3 years.

Carefully:Hyperuricemia, gout, hepatic insufficiency.

Dosing and Administration:Inside, during or after a meal, once a day, preferably at breakfast with a small amount of water, at a daily dose of 20-30 mg / kg (with a body weight of less than 50 kg -1.5 g, more than 50 kg - 2 grams ). Can be administered at 90 mg / kg 1 time per week, or 2-2.5 g 3 times a week, or 3-3.5 g 2 times a week. The maximum daily dose is 2.5 g. The course of treatment is 3 months or more.
In case of unsatisfactory tolerability, the drug is prescribed in 2-3 doses.
In elderly and senile patients, the daily dose should not exceed 15 mg / kg. In these cases, the drug should be administered every other day.
Children - 15-20 mg / kg once a day; the maximum daily dose is 1.5 g.
Pyrazinamide is used in combination with aminoglycosides (streptomycin or kanamycin at a dose of 15 mg / kg), isoniazid (10 mg / kg), rifampicin (10 mg / kg).

Side effects:On the part of the digestive system: nausea, vomiting, diarrhea, "metallic" taste in the mouth, impaired liver function (decreased appetite, liver tenderness, hepatomegaly, jaundice, yellow atrophy of the liver); exacerbation of peptic ulcer.
From the central nervous system: dizziness, headache, sleep disorders, increased excitability, depression; in some cases - hallucinations, convulsions, confusion.
On the part of the hematopoiesis and hemostasis system: thrombocytopenia, sideroblastic anemia, erythrocyte vacuolization, porphyria, hypercoagulation, splenomegaly.
From the musculoskeletal system: arthralgia, myalgia.
From the side of the urinary system: dysuria, interstitial nephritis.
Allergic reactions: skin rash, hives.
Other: hyperthermia, acne, hyperuricemia, exacerbation of gout, photosensitivity, increased serum iron concentration.

Overdose:Symptoms of an overdose: nausea, vomiting, abdominal pain, jaundice, increased liver enzymes, acute pulmonary edema, impaired consciousness, coma, convulsions, respiratory failure, hyperglycemia, metabolic ketoacidosis.
Treatment: gastric lavage with the introduction of activated carbon, forced diuresis, general measures to maintain vital functions, hemodialysis.

Interaction:Compatible with other antituberculous drugs: in chronic destructive forms pyrazinamide it is recommended to combine with rifampicin or ethambutol (better tolerability than when combined with rifampicin, but weaker effect).
The likelihood of developing a hepatotoxic effect increases when combined with rifampicin.
When used simultaneously with drugs that block tubular secretion, it is possible to reduce their excretion and enhance toxic reactions. Strengthens the anti-tuberculosis effect of ofloxacin and lomefloxacin.

Special instructions:With prolonged treatment, it is necessary to monitor the activity of alanine aminotransferase (ALT) and the concentration of uric acid in the blood once a month.
In patients with diabetes, the risk of hypoglycemia increases.

Form release / dosage:Tablets 500 mg.

Packaging:10 tablets per contour cell pack.
For 10 contour packs with instructions for use in a pack of cardboard.
For 1000 tablets per package of polyethylene film. The polyethylene bag together with the instruction for use is placed in a container of polypropylene (polyethylene) (for in-patient department).

Storage conditions:List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N002354 / 01

Date of registration:15.12.2008

Date of cancellation:2018-02-16

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp18.02.2018

Illustrated instructions

Instructions

Pyrazinamide-Acry® (Pyrazinamidum-Akri)