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Protubvita is combination of three anti-TB drugs and vitamin B6 (pyridoxine). Isoniazid shows a bactericidal effect against actively replicating Mycobacterium tuberculosis. It exerts its action by inhibiting synthesis of mycolic acids, a component of Mycobacterium cell wall. The minimum inhibitory concentration (MIC) of isoniazid against M. tuberculosis is 0.025-0.05 mg/L. Isoniazid has a moderate activity against slow- and rapid-growing atypical mycobacteria. Pyrazinamide has a bactericidal effect at an acid pH and penetrates well into tuberculous lesions. It is highly potent for the treatment of caseation necrosis, caseous lymphadenitis, and tuberculoma. It is enzymatically converted into pyrazinoic acid, its active form. At acid pH, MIC of pyrazinamide is 20 mg/L in vitro. It is not active against non-tuberculous pathogens. Rifampicin is a broad spectrum antibiotic inhibiting the synthesis of DNA-dependent RNA-polymerase. It is highly potent against mycobacteria, including M. tuberculosis, and some Gram-positive microorganisms and is less active against Gram-negative microorganisms. It has no cross-resistance with other antibiotics and chemotherapeutic agents. Pyridoxine (vitamin B6) is an important compound for metabolism. It is essential for the normal function of the central and peripheral nervous system. TB-infection results in pyridoxine deficiencies. So, the daily dose of this vitamin increases up to 60 mg. There are no pharmacokinetically or microbiologically relevant drug-drug interactions when pyridoxine is co-administered with isoniazid and pyrazinamide. Pyridoxine reduces neurotoxicity induced by anti-TB drugs.

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JSC Pharmasyntez

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