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Trecator (Ethionamide) - Summary



Trecator® (ethionamide tablets, USP) is used in the treatment of tuberculosis.

Trecator-SC (ethionamide) is primarily indicated for the treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs. Its use alone in the treatment of tuberculosis results in the rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility tests. If the susceptibility tests indicate that the patient's organism is resistant to one of the first-line antituberculosis drugs (i.e., isoniazid or rifampin) yet susceptible to ethionamide, ethionamide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to be susceptible.6 If the tuberculosis is resistant to both isoniazid and rifampin, yet susceptible to ethionamide, ethionamide should be accompanied by at least two other drugs to which the M. tuberculosis isolate is known to be susceptible.6

Patient nonadherence to prescribed treatment can result in treatment failure and in the development of drug-resistant tuberculosis, which can be life-threatening and lead to other serious health risks. It is, therefore, essential that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended for all patients receiving treatment for tuberculosis. Patients in whom drug-resistant M. tuberculosis organisms are isolated should be managed in consultation with an expert in the treatment of drug-resistant tuberculosis.

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Media Articles Related to Trecator (Ethionamide)

Tuberculosis (TB)
Source: MedicineNet Aches, Pain, Fever Specialty [2017.09.20]
Title: Tuberculosis (TB)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/20/2017 12:00:00 AM

Tuberculosis Skin Test (PPD Skin Test)
Source: MedicineNet Immunizations Specialty [2017.09.05]
Title: Tuberculosis Skin Test (PPD Skin Test)
Category: Procedures and Tests
Created: 1/13/2004 12:00:00 AM
Last Editorial Review: 9/5/2017 12:00:00 AM

Tuberculosis (TB) Treatment and Vaccine
Source: MedicineNet isoniazid, INH Specialty [2017.04.06]
Title: Tuberculosis (TB) Treatment and Vaccine
Category: Doctor's & Expert's views on Symptoms
Created: 10/30/2014 12:00:00 AM
Last Editorial Review: 4/6/2017 12:00:00 AM

Tuberculosis Diagnosis
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2017.03.29]
Title: Tuberculosis Diagnosis
Category: Doctor's & Expert's views on Symptoms
Created: 7/24/2013 12:00:00 AM
Last Editorial Review: 3/29/2017 12:00:00 AM

What Are the Symptoms and Signs of Tuberculosis (TB)?
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2017.03.29]
Title: What Are the Symptoms and Signs of Tuberculosis (TB)?
Category: Doctor's & Expert's views on Symptoms
Created: 10/29/2014 12:00:00 AM
Last Editorial Review: 3/29/2017 12:00:00 AM

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Published Studies Related to Trecator (Ethionamide)

A clinical trial of ethionamide and prothionamide for treatment of lepromatous leprosy. [2006.03]
In 1982-1984 we conducted a six-month clinical trial in 50 previously untreated lepromatous leprosy patients randomly assigned to directly observed monotherapy with one of two thioamides, ethionamide or prothionamide, each given six times a week at doses of either 250 mg or 500 mg... leprae in this study was found to be similar to that obtained previously with dapsone and clofazimine, but less than was obtained with rifampin, minocycline, clarithromycin, pefloxacin, and ofloxacin.

Pharmacokinetics of ethionamide administered under fasting conditions or with orange juice, food, or antacids. [2001.03]
This study was conducted in order to (i) determine the effect of food, orange juice, or antacids on the absorption of a single oral 500-mg dose of ethionamide (ETA) in healthy volunteers, including an assessment of bioequivalence, and (ii) determine ETA population pharmacokinetic (PK) parameters...

Pharmacokinetic evaluation of ethionamide suppositories. [1991]
The absorption and elimination of ethionamide (ETA) after oral tablets and rectal suppositories were determined in 12 healthy, adult male volunteers. A randomized, double-blind, double-dummy, crossover design was used... Higher doses of ETA and serum concentration monitoring are recommended whenever the suppositories are used.

Pharmacokinetics and tissue distribution studies of orally administered nanoparticles encapsulated ethionamide used as potential drug delivery system in management of multi-drug resistant tuberculosis. [2011.01]
Sustained release nanoformulations of second line anti-tubercular drugs can help in reducing their dosing frequency and improve patient's compliance in multi-drug resistant tuberculosis (MDR TB). The objective of the current study was to investigate the pharmacokinetics and tissues distribution of ethionamide encapsulated in poly (DL-lactide-co-glycolide) (PLGA) nanoparticles...

Ethionamide cross- and co-resistance in children with isoniazid-resistant tuberculosis. [2009.11]
BACKGROUND: Ethionamide (ETH) is a structural analogue of isoniazid (INH). Both are pro-drugs requiring activation by separate and common enzyme pathways, which could lead to co- and/or cross-resistance. OBJECTIVE: To characterise paediatric INH-resistant mycobacterial isolates to investigate the presence of ETH resistance and mutations in the katG gene and the inhA promoter region... CONCLUSION: We found a high level of cross- and co-resistance with ETH among INH-resistant M. tuberculosis isolates from children in this geographic area.

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Clinical Trials Related to Trecator (Ethionamide)

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis [Not yet recruiting]
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional empiric injection-based regimen of 21-24 months treatment. The secondary aim is to determine if other treatment-related outcomes including adverse events, adherence to treatment, culture conversion, and cure/completion are significantly different in the intervention and conventional arms.

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients. [Completed]
To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.

Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) [Recruiting]
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207 and its primary metabolite M2.

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Page last updated: 2017-09-20

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