Composition, form of production and packaging
The tablets covered with a cover of white color, round, biconcave, with a notch on one side.
pyrazinamide 500 mg
Excipients: lactose 17 mg, microcrystalline cellulose 20 mg, colloidal colloidal silicon 9 mg, crospovidone 15 mg, croscarmellose 15 mg, copolyvidone 9.25 mg, hydroxypropyl methylcellulose 8.75 mg, magnesium stearate 6 mg.
Sheath composition: hypromellose (hydroxypropylmethylcellulose) - 3.43 mg, titanium dioxide - 1.52 mg, macrogol 6000 (polyethylene glycol 6000) - 1.72 mg.
100 pieces. - polypropylene containers (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
[I] - Instruction on medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on 27.07.2000
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.
Pyrazinamide is well absorbed from the digestive tract. After oral administration of a dose of 500 mg in adult C max pyrazinamide in blood plasma within 9-12 Ојg / ml is achieved within 2 hours, 7 Ојg / ml after 8 hours and 2 Ојg / ml after 24 hours. Pyrazinamide penetrates into tissues and body fluids, including the liver, lungs, cerebrospinal fluid. Approximately 50% bind to plasma proteins, T 1/2 is 9-10 hours in those patients whose liver and kidney function are not impaired. Within 24 hours about 70% of the ingested dose is excreted by the kidneys. About 4-14% of the dose is released unchanged. The residues are excreted as metabolites.
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;
The drug is used inside during or after a meal, once a day, preferably during 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, Pirafat is prescribed in 2-3 sessions.
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 prescribed 15-20 mg / kg 1 time / day (maximum - up to 1.5 grams per day).
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).
The course of treatment - 3 months.
On the part of the digestive system: nausea, vomiting, diarrhea, lack of appetite, unpleasant metallic taste in the mouth, epigastric pain, violations of the liver function.
From the side of the central nervous system: with prolonged use - headache, dizziness, increased excitability, depression, sleep disturbance, weakness; in some cases - confusion, hallucinations, convulsions.
Possible: allergic reactions, arthralgia, hyperureukemia, exacerbation of gout, photosensitivity. There is evidence of a delay in the body under the influence of pyrazinamide of 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.
- individual intolerance;
- liver disease;
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in liver diseases.
APPLICATION FOR CHILDREN
Children are prescribed 15-20 mg / kg once a day (maximum to 1.5 g per day).
APPLICATION IN ELDERLY PATIENTS
In elderly and senile patients, 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.
Pyrazinamide is combined with other anti-tuberculosis 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 hepatotoxic 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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Protect from moisture and light. Keep out of the reach of children
Shelf life - 4 years.
Do not use after the expiration date printed on the package.