ABSTRACT
Availability of adequate and proper drug information helps in rational prescription of essential drugs. This can be obtained from various sources such as National Formularies; other sources such as Current Index of Medical Specialties, Monthly index of medical specialties and the information available with the regulators and drug package inserts (PI). In this study, we assessed the drug information of the drugs used for treatment of both type of lepra reactions. Five drugs used for treating Lepra reactions were analyzed for any variation (Qualitative) in information on various parameters as mentioned in commonly used drug information sources such as CIMS India, MIMS India, Central Drugs and Standards Control Organization (CDSCO) website and National Formulary of India (NFI). We observed some gross qualitative variation regarding drug information given in different commonly used sources. Variation exists in the quality of information available on indications, contraindications, dosage and completeness of the dosing schedule about drugs available in various sources. As management of Lepra reactions is crucial in achievement desirable outcome of treatment of leprosy, it is important that information regarding drugs used for such indications should be 100% uniform in all commonly used and available sources.
ABSTRACT
Multidrug-resistant tuberculosis (MDR-TB) is a global public health problem. It requires treatment with combination therapy consisting of four to six drugs including combinations of bactericidal and bacteriostatic drugs, usually for a period of 2 years. There is alarming rise in MDR and XDR-TB all over the world and better treatment options are needed to control the global MDR-TB and XDR-TB epidemic. Drugs which can shorten the treatment duration and which are free from serious adverse effects are urgently needed. Bedaquiline (TMC-207) is a newly FDA approved anti-TB drug, having unique mechanism of action i.e. causes inhibition of the proton pump activity of the ATP synthase in M. tuberculosis and targets the energy metabolism. It is found to active within macrophages, and is a promising agent in shortening the duration of anti- TB treatment. It is metabolized by CYP3A4, so interactions with inducers and inhibitors of this enzyme are expected. It has shown promising results in preclinical and clinical studies and it seems to be a good option for MDR and XDR-TB. Adverse effects reported in various studies were of mild nature except nausea which was the most commonly associated. Few cases of prolongation of QT intervals were reported, so it demands careful monitoring and use of bedaquiline as a reserve drug for patients in whom conventional regimens are not effective. Currently it is approved as part of combination therapy in adults of ≥18 year with pulmonary MDR-TB. Long term studies are needed to explore its full safety profile.