Trecator SC: Targeted Tuberculosis Treatment with Ethionamide
| Product dosage: 250 mg | |||
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Synonyms | |||
Trecator SC (ethionamide) is an essential second-line antimycobacterial agent indicated for the treatment of active tuberculosis (TB), specifically when first-line regimens are ineffective or not tolerated. As a nicotinamide derivative, it exerts bacteriostatic activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids, critical components of the mycobacterial cell wall. Its role is pivotal within combination therapy protocols to prevent resistance development and ensure comprehensive microbial eradication. This medication is reserved for cases of drug-resistant TB or when patients exhibit significant adverse reactions to primary agents, underscoring its specialized application under strict clinical supervision.
Features
- Contains ethionamide as the active pharmaceutical ingredient
- Available in 250 mg film-coated tablets for precise dosing
- Designed for oral administration with or without food, though taking with meals may improve gastrointestinal tolerance
- Manufactured under current Good Manufacturing Practices (cGMP) ensuring pharmaceutical quality and batch consistency
- Requires prescription and is typically dispensed with directly observed therapy (DOT) protocols in many treatment settings
Benefits
- Provides a critical therapeutic option for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) cases
- Works synergistically with other second-line antitubercular agents to enhance treatment efficacy and reduce the risk of further resistance
- Oral formulation supports outpatient treatment adherence and reduces need for prolonged hospitalization
- Demonstrated ability to achieve bactericidal concentrations in tubercular lesions, including cavities
- Helps shorten overall treatment duration when incorporated into optimized regimen designs
- Contributes to global TB control efforts by salvaging treatment in complex resistance scenarios
Common use
Trecator SC is primarily used as part of a combination regimen for pulmonary and extrapulmonary tuberculosis when resistance to isoniazid and/or rifampin has been confirmed or is strongly suspected. It is indicated for both adult and pediatric patients (though careful dose adjustment is required in children) as part of individualized treatment plans developed by TB specialists. Its use is typically guided by drug susceptibility testing results and previous treatment history. The medication may also be employed in cases of genuine intolerance to first-line agents, though this requires thorough benefit-risk assessment given its side effect profile.
Dosage and direction
Dosage must be individualized based on patient weight, concomitant medications, and clinical response. For adults: 15-20 mg/kg/day (typically 500-1000 mg daily) in divided doses, usually 2-3 times daily. For children: 15-20 mg/kg/day in divided doses 2-3 times daily, not to exceed 1 g/day. Administration with food may minimize gastrointestinal upset. Tablets should be swallowed whole with water; they should not be crushed or chewed. Dosage escalation (starting with 250 mg daily and increasing gradually over 3-5 days) may improve tolerance. Treatment duration typically ranges from 12-24 months depending on resistance pattern and treatment response, always as part of combination therapy.
Precautions
Hepatic function should be monitored before initiation and regularly during therapy due to risk of hepatotoxicity. Baseline visual acuity testing is recommended, with periodic follow-up, as optic neuritis has been reported. Endocrinological monitoring is advised as ethionamide may cause hypothyroidism, especially in patients with preexisting thyroid disorders. Use with caution in patients with diabetes mellitus due to potential for hypoglycemia. Psychiatric symptoms should be monitored, particularly in patients with history of mental health disorders. Pregnancy category C: use only if potential benefit justifies potential risk to fetus. Not recommended during breastfeeding.
Contraindications
Hypersensitivity to ethionamide or any component of the formulation. Severe hepatic impairment (Child-Pugh Class C). Concurrent use with certain psychotropic medications that lower seizure threshold. Not recommended as monotherapy under any circumstances due to rapid development of resistance. Should not be used in patients with acute porphyria.
Possible side effect
Gastrointestinal disturbances are most common: nausea (30-50%), vomiting (10-30%), abdominal pain, diarrhea, metallic taste, excessive salivation. Hepatotoxicity (5-10%) ranging from transient transaminase elevations to clinical hepatitis. Neurological effects: dizziness, headache, peripheral neuropathy, optic neuritis, psychiatric disturbances (depression, anxiety, psychosis). Endocrinological: hypothyroidism, gynecomastia. Dermatological: rash, photosensitivity, acne. Miscellaneous: arthralgia, hypoglycemia, orthostatic hypotension.
Drug interaction
Enhanced hepatotoxicity risk with other hepatotoxic drugs (especially other antitubercular medications). May potentiate effects of oral hypoglycemics and insulin requiring dose adjustment. Concurrent use with cycloserine may increase neurotoxic effects. Alcohol consumption may increase risk of seizures and psychosis. May reduce efficacy of oral contraceptives; alternative contraception recommended. Interaction with phenytoin may require monitoring of phenytoin levels. Concomitant use with disulfiram may cause psychotic reactions.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. Consistent adherence is critical to prevent development of resistance; patients should maintain a dosing diary and utilize medication reminders. Any pattern of missed doses should be discussed immediately with the healthcare provider to assess potential impact on treatment efficacy.
Overdose
Symptoms may include severe gastrointestinal distress (nausea, vomiting), neurological symptoms (dizziness, confusion, seizures), and potential hepatotoxicity. There is no specific antidote. Management is supportive and symptomatic: gastric lavage if presented early, activated charcoal if appropriate, and aggressive symptomatic treatment. Hospitalization is recommended for observation and monitoring of hepatic and neurological status. Hemodialysis is not likely to be effective due to high protein binding. Contact poison control center immediately for guidance.
Storage
Store at controlled room temperature (20-25°C or 68-77°F). Keep container tightly closed and protect from moisture and light. Keep out of reach of children and pets. Do not use after expiration date printed on packaging. Do not transfer tablets to other containers as this may affect stability. Proper disposal of unused medication is essential to prevent accidental ingestion or environmental contamination.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be consulted for complete information regarding indications, dosage, warnings, and precautions. Never initiate, adjust, or discontinue medication without professional medical supervision.
Reviews
“Trecator SC remains an indispensable component of our MDR-TB treatment arsenal. While its side effect profile demands careful management, its efficacy against resistant strains justifies its continued use in optimized regimens.” - Infectious Disease Specialist, TB Reference Center
“In our cohort of XDR-TB patients, ethionamide-containing regimens achieved culture conversion in 68% of cases where other options had failed. The gastrointestinal side effects are challenging but manageable with dose titration and antiemetics.” - Clinical Research, National TB Institute
“Despite newer agents, ethionamide maintains relevance in specific resistance patterns. Our program uses therapeutic drug monitoring to optimize dosing and minimize toxicity, significantly improving tolerability.” - PharmD, TB Specialty Pharmacy