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

Composition:1 tablet contains:
Active substance: pyrazinamide 500.00 mg;
Excipients: core: lactose 17.00 mg, microcrystalline cellulose 20.00 mg, colloidal silicon dioxide 9.00 mg, crospovidone 15.00 mg, croscarmellose 15.00 mg, copolyvidone 9.25 mg, hydroxypropylmethylcellulose 8.75 mg, magnesium stearate 6.00 mg;
shell: hypromellose (hydroxypropylmethylcellulose) 3.43 mg, titanium dioxide 1.52 mg, macrogol 6000 (polyethylene glycol 6000) 1.72 mg.

Description:White round biconvex tablets with a notch on one side.

Pharmacotherapeutic group:Anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K.01 Pyrazinamide

Pharmacodynamics:Has a bacteriostatic or bactericidal effect depending on the concentration and sensitivity of the microorganism. More active on tuberculostatic activity than PASK, although inferior to isoniazid, streptomycin, rifampicin. It operates on mycobacteria, resistant to other anti-tuberculosis drugs of the II series. The drug penetrates well into the centers of tuberculous lesion. Its activity does not decrease in the acidic environment of caseous masses, and therefore it is often prescribed for caseous lymphadenitis, tuberculomas and caseous-pneumonic processes.

Pharmacokinetics:Pyrazinamide well absorbed from the digestive tract. After oral administration of a dose of 500 mg to adults, the peak concentration of pyrazamide in blood plasma within 9-12 μg / ml is achieved within 2 hours, 7 μg / ml after 8 hours and 2 μg / ml after 24 hours. Pyrazinamide penetrates the tissues and body fluids, including the liver, lungs, cerebrospinal fluid. Approximately 50% binds to plasma proteins. The half-life is 9-10 hours in those patients whose liver and kidney function are not impaired. Within 24 hours, about 70% of the oral dose is excreted by the kidneys.About 4-14% of the dose is released unchanged. The residues are excreted as metabolites.

Indications:Apply the drug with a therapeutic purpose for the appointment of a doctor for tuberculosis.
In combination with other anti-tuberculosis drugs are prescribed in the following cases:
- pulmonary tuberculosis;
- tuberculous meningitis;
- tuberculosis of bones;
urogenital tuberculosis.

Contraindications:- individual intolerance;
- liver disease;
- gout;
- Hyperuricemia;
- Pregnancy, lactation.

Dosing and Administration:The drug is used inside during or after a meal, once a day, preferably at breakfast with a little water.
Adults appoint 25-30 mg / kg body weight, which corresponds to those with a body weight of less than 50 kg - 1.5 g and for individuals with a body weight of more than 50 kg - 2 g.
The maximum daily dose is 2.5 g.
In case of unsatisfactory portability Pyrazinamide appoint 2-3 reception.
In elderly and elderly people, the daily dose of pyrazinamide should not exceed 15 mg / kg of body weight. In these cases, the drug should be administered every other day.
Children are prescribed 15-20 mg / kg once a day (maximum to 1.5 g per day).
Pyrazinamide is used in combination with aminoglycosides (streptomycin or kanamycin in a dose of 15 mg / kg), isoniazid (10 mg / kg), rifampicin (10 mg / kg).
The course of treatment is 3 months.

Side effects:From the gastrointestinal tract: nausea, vomiting, diarrhea, lack of appetite, unpleasant metallic taste in the mouth, epigastric pain. Violation of the function of the liver.
From the central nervous system: with prolonged use - headache, dizziness, increased excitability, depression, sleep disturbance, weakness; in some cases - confusion, hallucinations, convulsions;
There are allergic reactions, arthralgia, hyperureukemia, exacerbation of gout, photosensitivity. There is evidence of a delay in the body under the influence of pyrazinamide, uric acid, and possibly the appearance of arthritic pain in the joints. Therefore, it is advisable to monitor the activity of hepatic transaminases and the content of uric acid in the blood regularly (at least once a month).
With prolonged use may have toxic effects on the liver.

Interaction:Pyrazinamide are combined with other antituberculosis drugs.In particular, with chronic destructive forms it is recommended to combine it with rifampicin (pronounced effect) or ethambutol (better tolerability). The likelihood of developing a hepatoxic effect of the drug is increased when combined with rifampicin. Possible development of hypoglycemia in patients with diabetes. With simultaneous application with probenecid, a decrease in excretion and, consequently, an increase in toxic reactions is possible.

Form release / dosage:Tablets coated with a coating containing 500 mg of pyrazinamide.

Packaging:For 100 tablets in a container of white color from polypropylene with a white lid of low density polyethylene with a ring of the first opening, the empty space is filled with foam rubber sealant, a label is attached to the container. A container of 100 tablets together with the instruction for use is placed in a cardboard box.
For 1000 tablets in a brown PVC container with a protective membrane of low-density polyethylene and a screw cap of black color from Bakelite with a PVC substrate, the empty space is filled with foam rubber sealant, the instructions for use are placed on top of it, a label is attached to the container.10, 16, 20, 30, 40 containers (1000 tablets each) are placed in a cardboard box (for hospitals).

Storage conditions:List B.
Store at a temperature not exceeding + 25 ° С.
Protect from moisture and light.
Keep out of the reach of children.

Shelf life:4 years.
Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:П N014965 / 01-2003

Date of registration:08.05.2009

The owner of the registration certificate:Rimzer Artsynaimitel, AGRimzer Artsynaimitel, AG Germany

Manufacturer: & nbsp

FATOL ARZNEIMITTEL subsidiary of RIEMSER ARZNEIMITTEL, AG Germany

Information update date: & nbsp30.07.2015

Illustrated instructions

Instructions

Pirafat (Pyrafat)