Trecator (Ethionamide) - Summary

TRECATOR 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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NEWS HIGHLIGHTS

Media Articles Related to Trecator (Ethionamide)

Arthritis Drug Raises Risk of Tuberculosis
Source: MedicineNet Ankylosing Spondylitis Specialty [2009.07.10]
Title: Arthritis Drug Raises Risk of Tuberculosis
Category: Health News
Created: 7/10/2009 7:00:00 AM
Last Editorial Review: 7/10/2009

Tuberculosis
Source: MedicineNet Erythema Nodosum Specialty [2008.01.17]
Title: Tuberculosis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 1/17/2008

Extensively Drug-Resistant Tuberculosis (XDR TB)
Source: MedicineNet ICU Psychosis Specialty [2007.05.30]
Title: Extensively Drug-Resistant Tuberculosis (XDR TB)
Category: Diseases and Conditions
Created: 5/30/2007
Last Editorial Review: 5/30/2007

Opinions: Fighting TB; Currency Transaction Tax
Source: Health News from Medical News Today [2009.11.19]
Innovation, Coordination Needed To 'Bring TB Research Into The 21st Century' Though tuberculosis "is one of the world's leading killers … few citizens, scientists and policymakers are demanding more attention to TB research, treatment and prevention.

Global Fund Approves $2.4B For Ninth Round Grants
Source: HIV / AIDS News From Medical News Today [2009.11.16]
During its recent board meeting in Addis Ababa, Ethiopia, the Global Fund to Fight AIDS, Tuberculosis and Malaria approved $2.4 billion for the three diseases, PlusNews reports. The money is for the fund's "ninth round of grants, bringing the total amount of approved funding since its inception in 2001 to $18.4 billion," according to the publication.

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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.

Radiometric vs. agar proportion methods for assessing ethionamide resistance and its clinical effects in multidrug-resistant tuberculosis. [2009.07]
SETTING: Three centres for the treatment of multidrug-resistant tuberculosis (MDR-TB) in Istanbul, Turkey: Heybeliada Centre for Chest Diseases and Thoracic Surgery, Sureyyapasa Centre for Chest Diseases and Thoracic Surgery and Yedikule Centre for Chest Diseases and Thoracic Surgery. OBJECTIVE: To evaluate the presence of ethionamide (ETH) resistance and its effect on time to sputum smear negativity in MDR-TB patients who had not previously received second-line anti-tuberculosis drugs... CONCLUSION: Not only ETH resistance but also age and radiologically advanced disease adversely affected time to sputum conversion.

Synthetic EthR inhibitors boost antituberculous activity of ethionamide. [2009.05]
The side effects associated with tuberculosis therapy bring with them the risk of noncompliance and subsequent drug resistance... This provides proof of concept that inhibiting EthR improves the therapeutic index of thiocarbamide derivatives, which should prompt reconsideration of their use as first-line drugs.

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Clinical Trials Related to Trecator (Ethionamide)

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.

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