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Rifampicin-isoniazid induced fatal fulminant hepatitis during treatment of latent tuberculosis: A case report and literature review
Khan Fahmi,Rasoul Fatima
Indian Journal of Critical Care Medicine , 2010,
Abstract: A 42-year-old Indian man received 450 mg rifampicin (RIF) and 150 mg isoniazid (INH) daily after being diagnosed of a latent tuberculosis infection. Baseline serum aminotransferase and total bilirubin levels were within normal limits. On day 31 of treatment, the patient experienced epigastric discomfort and general malaise and one week later he developed nausea and episodic vomiting. The patient missed his first scheduled clinic appointment and he continued taking RIF-INH despite his symptoms. He visited the tuberculosis clinic on day 47 of treatment where he was found to be jaundiced and his liver enzymes were elevated. RIF-INH was stopped and the patient was admitted to our hospital as a case of RIF-INH induced hepatitis. On the 7th day of hospitalization, the patient developed consciousness disturbance with flapping tremor and high ammonia level. The patient was diagnosed with fulminant hepatic failure and transferred immediately to the medical intensive care unit, where he died 4 days later.
Effect of two different superdisintegrants on combinaion dispersible tablets of isoniazid and rifampicin for oral treatment of tuberculosis  [cached]
Vikesh Shukla,F.V. Manvi
International Journal of Drug Delivery , 2011,
Abstract: Oral route of administration have wide acceptance up to 50-60% to total drug forms. Fast disintegrating drug delivery system has number of advantage such as faster onset of action, attractive elegance, ease of administration. In this study, an attempt has been made to study direct compression method, for formulation of fast disintegrating tablets of Isoniazid and Rifampicin, an anti-tubercular drug in view of enhancing bioavailability. These formulations have sufficient hardness and can be manufactured by commonly used equipment. Prior to formulation the pre-compression parameters were characterized for flow properties and prepared formulations were evaluated for physico-chemical parameters, X-ray powder crystallography, SEM and in-vivo bioavailability. All four formulations possessed good disintegration properties with total disintegration time of 25 to 40 seconds. The effects of different superdisintegrants and process variables on drug release profile and disintegration property were evaluated and results revealed the better drug release with different superdisintegrants such as Ac-di sol and Polyplastadone XL. All formulations are rapidly disintegrated in oral cavity as well as all formulations possess good anti-tubercular properties. SEM Showed the mechanical strength of the formulations affected the morphological changes after compression. Hence, it is evident from this study that fast dispersible tablets could be a promising delivery system for Isoniazid, Rifampicin and their combination with good mouth feel and improved drug availability with better patient compliance. Keywords: Isoniazid; Rifampicin; Superdisintegrants; Direct compression method; Bioavailability.
High Isoniazid Resistance Rates in Rifampicin Susceptible Mycobacterium tuberculosis Pulmonary Isolates from Pakistan  [PDF]
Naima Fasih, Yasraba Rafiq, Kausar Jabeen, Rumina Hasan
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0050551
Abstract: Background Rapid new diagnostic methods (including Xpert MTB/RIF assay) use rifampicin resistance as a surrogate marker for multidrug resistant tuberculosis. Patients infected with rifampicin susceptible strains are prescribed first line anti-tuberculosis therapy. The roll out of such methods raises a concern that strains with resistance to other first line anti-tuberculosis drugs including isoniazid will be missed and inappropriate treatment given. To evaluate implications of using such methods review of resistance data from high burden settings such as ours is essential. Objective To determine resistance to first line anti-tuberculosis drugs amongst rifampicin susceptible pulmonary Mycobacterium tuberculosis (MTB) isolates from Pakistan. Materials and Methods Data of pulmonary Mycobacterium tuberculosis strains isolated in Aga Khan University Hospital (AKUH) laboratory (2009–2011) was retrospectively analyzed. Antimicrobial susceptibility profile of rifampicin susceptible isolates was evaluated for resistance to isoniazid, pyrazinamide, ethambutol, and streptomycin. Results Pulmonary specimens submitted to AKUH from 2009 to 2011 yielded 7738 strains of Mycobacterium tuberculosis. These included 54% (n 4183) rifampicin susceptible and 46% (n: 3555) rifampicin resistant strains. Analysis of rifampicin susceptible strains showed resistance to at least one of the first line drugs in 27% (n:1133) of isolates. Overall isoniazid resistance was 15.5% (n: 649), with an isoniazid mono-resistance rate of 4% (n: 174). Combined resistance to isoniazid, pyrazinamide, and ethambutol was noted in 1% (n: 40), while resistance to isoniazid, pyrazinamide, ethambutol, and streptomycin was observed in 1.7% (n: 70) of strains. Conclusions Our data suggests that techniques (including Xpert MTB/RIF assay) relying on rifampicin susceptibility as an indicator for initiating first line therapy will not detect patients infected with MTB strains resistant to other first line drugs (including isoniazid). The roll out of these techniques must therefore be accompanied by strict monitoring ensuring early resistance detection to increase chances of improved patient outcomes.
High frequency of resistance to the drugs isoniazid and rifampicin among tuberculosis cases in the city of Cabo de Santo Agostinho, an urban area in Northeastern Brazil
Baliza, Marcilio;Bach, Artur Henrique;Queiroz, Gabriel Lobo de;Melo, Inês Cardoso;Carneiro, Maria Madileuza;Albuquerque, Maria de Fátima Pessoa Milit?o de;Suffys, Philip;Rodrigues, Laura;Ximenes, Ricardo;Lucena-Silva, Norma;
Revista da Sociedade Brasileira de Medicina Tropical , 2008, DOI: 10.1590/S0037-86822008000100003
Abstract: the objective of the present study was to investigate the frequency and risk factors for developing multidrug-resistant tuberculosis in cabo de santo agostinho, pe. this was a prospective study conducted from 2000 to 2003, in which suspected cases were investigated using bacilloscopy and culturing. out of 232 confirmed cases of tuberculosis, culturing and antibiotic susceptibility tests were performed on 174. thirty-five of the 174 cultures showed resistance to all drugs. the frequencies of primary and acquired resistance to any drug were 14% and 50% respectively, while the frequencies of primary and acquired multidrug resistance were 8.3% and 40%. previous tuberculosis treatment and abandonment of treatment were risk factors for drug resistance. the high levels of primary and acquired resistance to the combination of isoniazid and rifampicin contributed towards the difficulties in controlling tuberculosis transmission in the city.
Combined drug medium with isoniazid and rifampicin for identification of multi-drug resistant Mycobacterium tuberculosis  [cached]
Nalini S,Lakshmi R,Devika K,Ravikumar D
Indian Journal of Medical Microbiology , 2010,
Abstract: A low-cost method of detecting multi-drug resistant Mycobacterium tuberculosis (MDR-TB) with the possibility of quick adoption in a resource limited setting is urgently required. We conducted a study combining isoniazid and rifampicin in a single LJ medium, to detect MDR-TB strains. Combined and individual drug media showed 100% concordance for the detection of MDR-TB and susceptible strains by proportion method. Considering the results, combined isoniazid and rifampicin containing medium could be considered for use in settings where the sole detection of MDR-TB strains is justified.
Evaluation of Biochip System in Determining Isoniazid and Rifampicin Resistances of Mycobacterium Tuberculosis in Sputum Samples  [PDF]
Wei Lu, Cheng Chen, Yan Shao, Jinyan Shi, Chongqiao Zhong, Dandan Yang, Honghuan Song, Guoli Li, Xiaoyan Ding, Hong Peng, Linyang Zhu, Yang Zhou, Limei Zhu
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0052953
Abstract: Objective To evaluate a biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples in a Chinese population. Methods We assembled 907 sputum smeared positive specimens of tuberculosis patients in total. Each sample would be separated into two parts for culture and biochip assay simultaneously. And those cultured positive and having full drug resistance results would be used as reference. The McNemar χ2 test was adopted for evaluating the paired 2×2 table. Results Compared with drug sensitivity test, the agreement rates of the two methods in detecting rifampicin and isoniazid resistances were 93.37% and 94.49%, respectively. The sensitivity and specificity of biochip in detecting isoniazid were 74.31% and 96.92%, respectively. Meanwhile, the sensitivity and specificity for rifampicin were 79.76% and 96.53%, respectively. For multi-drug resistance, the sensitivity and specificity were 64.62% and 97.75%, respectively. Conclusions The biochip system is a rapid and accurate method for drug resistant tuberculosis diagnosis using sputum samples directly, especially for rifampicin resistance detection.
Do We Need to Detect Isoniazid Resistance in Addition to Rifampicin Resistance in Diagnostic Tests for Tuberculosis?  [PDF]
Claudia M. Denkinger, Madhukar Pai, David W. Dowdy
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0084197
Abstract: Background Multidrug-resistant tuberculosis (MDR-TB) is resistant to both rifampicin (RIF) and isoniazid (INH). Whereas many TB diagnostics detect RIF-resistance, few detect INH-monoresistance, which is common and may increase risk of acquired MDR-TB. Whether inclusion of INH-resistance in a first-line rapid test for TB would have an important impact on MDR-TB rates remains uncertain. Methods We developed a transmission model to evaluate three tests in a population similar to that of India: a rapid molecular test for TB, the same test plus RIF-resistance detection (“TB+RIF”), and detection of RIF and INH-resistance (“TB+RIF/INH”). Our primary outcome was the prevalence of INH-resistant and MDR-TB at ten years. Results Compared to the TB test alone and assuming treatment of all diagnosed MDR cases, the TB+RIF test reduced the prevalence of MDR-TB among all TB cases from 5.5% to 3.8% (30.6% reduction, 95% uncertainty range, UR: 17–54%). Despite using liberal assumptions about the impact of INH-monoresistance on treatment outcomes and MDR-TB acquisition, expansion from TB+RIF to TB+RIF/INH lowered this prevalence only from 3.8% to 3.6% further (4% reduction, 95% UR: 3–7%) and INH-monoresistant TB from 15.8% to 15.1% (4% reduction, 95% UR: (-8)-19%). Conclusion When added to a rapid test for TB plus RIF-resistance, detection of INH-resistance has minimal impact on transmission of TB, MDR-TB, and INH-monoresistant TB.
Development and validation of an electroanalytical methodology for determination of isoniazid and rifampicin content in pharmaceutical formulations
Leandro, Katia Christina;Carvalho, Juliana Machado de;Giovanelli, Luiz Fernando;Moreira, Josino Costa;
Brazilian Journal of Pharmaceutical Sciences , 2009, DOI: 10.1590/S1984-82502009000200019
Abstract: tuberculosis remains a major public health problem, especially in developing countries. brazil presents the largest number of cases in latin america and is among the 22 countries considered priorities by the world health organization (who). the rio de janeiro state has the largest number of cases registered in the country. the treatment of patients, commonly, makes use of the drugs isoniazid and rifampicin for six months. this study aimed to develop and validate an electroanalytical methodology, using the technique of differential pulse voltammetry for the determination of these drugs in the associated form, in order to evaluate the quality of medicines distributed in the state of rio de janeiro. the potential reduction for the isoniazid and rifampicin were -1.10 and -0.90 v. the developed and validated electroanalytical method presented a linear range of 0.25 to 1.25 mg/l to isoniazid, limits of detection and quantification of 0.05 and 0.14 mg/l, and recovery of 98.2 ± 0.4%; a tracking linear of 0.40 to 2.00 mg/l for rifampicin, with limits of detection and quantification of 0.07 and 0.19 mg/l and recovery of 95.8 ± 0.6%. six lots of medicines from two pharmaceutical companies were analyzed. only one of the samples showed unsatisfactory levels of rifampicin.
Evaluation of rapid MTT tube method for detection of drug susceptibility of mycobacterium tuberculosis to rifampicin and isoniazid
Raut U,Narang P,Mendiratta D,Narang R
Indian Journal of Medical Microbiology , 2008,
Abstract: Purpose: To evaluate MTT method for detection of drug resistance to rifampicin and isoniazid in M.tuberculosis . This method utilises the ability of viable mycobacterial cells to reduce MTT( 3-4,5-dimethylthiazol-2-yl-2, 5-diphenyl tetrazolium bromide). Methods: The method was standardised with known resistant and sensitive strains of M.tuberculosis and was then extended to 50 clinical isolates. An inoculum of 10 7 cfu/mL was prepared in Middlebrook 7H9 medium supplemented with oleic acid, albumin, dextrose and catalase. For each drug three tubes were used, one with INH(0.2μg/mL) or RIF(1μg/mL), another as inoculum control and third as blank control. These were incubated at 37°C for four and seven days respectively for RIF and INH after which MTT assay was performed. Results were read visually and by colorimeter at 570 nm. Relative optical density unit (RODU) of 0.2 was taken as cut off. Results were compared with drug sensitivity obtained by proportion method using LJ medium. Results: For rifampicin, concordance with proportion method was 90% by visual and 94% by RODU. Sensitivity and specificity was 86.8% and 100% respectively by visual method and 95.2% and 87.5% respectively by RODU. For Isoniazid, concordance was 94% and sensitivity and specificity was 94.7 and 91.7% respectively by both visual and RODU. Conclusions: MTT assay proved to be rapid and cheap method for performing drug sensitivity of M.tuberculosis
Contribution of Efflux to the Emergence of Isoniazid and Multidrug Resistance in Mycobacterium tuberculosis  [PDF]
Diana Machado, Isabel Couto, Jo?o Perdig?o, Liliana Rodrigues, Isabel Portugal, Pedro Baptista, Bruno Veigas, Leonard Amaral, Miguel Viveiros
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0034538
Abstract: Multidrug resistant (MDR) tuberculosis is caused by Mycobacterium tuberculosis resistant to isoniazid and rifampicin, the two most effective drugs used in tuberculosis therapy. Here, we investigated the mechanism by which resistance towards isoniazid develops and how overexpression of efflux pumps favors accumulation of mutations in isoniazid targets, thus establishing a MDR phenotype. The study was based on the in vitro induction of an isoniazid resistant phenotype by prolonged serial exposure of M. tuberculosis strains to the critical concentration of isoniazid employed for determination of drug susceptibility testing in clinical isolates. Results show that susceptible and rifampicin monoresistant strains exposed to this concentration become resistant to isoniazid after three weeks; and that resistance observed for the majority of these strains could be reduced by means of efflux pumps inhibitors. RT-qPCR assessment of efflux pump genes expression showed overexpression of all tested genes. Enhanced real-time efflux of ethidium bromide, a common efflux pump substrate, was also observed, showing a clear relation between overexpression of the genes and increased efflux pump function. Further exposure to isoniazid resulted in the selection and stabilization of spontaneous mutations and deletions in the katG gene along with sustained increased efflux activity. Together, results demonstrate the relevance of efflux pumps as one of the factors of isoniazid resistance in M. tuberculosis. These results support the hypothesis that activity of efflux pumps allows the maintenance of an isoniazid resistant population in a sub-optimally treated patient from which isoniazid genetically resistant mutants emerge. Therefore, the use of inhibitors of efflux should be considered in the development of new therapeutic strategies for preventing the emergence of MDR-TB during treatment.
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