Trecator SC: Targeted Tuberculosis Treatment for Resistant Strains
| Product dosage: 250 mg | |||
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Synonyms | |||
Trecator SC (ethionamide) is a second-line antimycobacterial agent specifically formulated for the treatment of active tuberculosis when first-line therapies prove ineffective or intolerable. This bacteriostatic antibiotic works by inhibiting the synthesis of mycolic acids, essential components of the mycobacterial cell wall, thereby halting bacterial replication. It is indicated for use in multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) regimens, always administered in combination with other antitubercular drugs to prevent resistance development. Clinical use requires careful monitoring due to its side effect profile and potential interactions.
Features
- Contains 250 mg ethionamide per scored tablet
- Bacteriostatic action against Mycobacterium tuberculosis
- Inhibits mycolic acid synthesis through disruption of the enoyl-acyl carrier protein reductase (InhA)
- Bioavailability approximately 80–90% when taken orally
- Crosses the blood-brain barrier, making it suitable for tuberculous meningitis
- Metabolized primarily in the liver
- Excreted mainly renally
Benefits
- Provides a critical therapeutic option when first-line TB drugs (isoniazid, rifampin) fail or cannot be used
- Effective against certain drug-resistant strains of tuberculosis when used in combination therapy
- Oral administration facilitates outpatient treatment and improves adherence compared to injectable second-line agents
- Demonstrated efficacy in both pulmonary and extrapulmonary tuberculosis, including CNS involvement
- Allows for tailored regimen design in complex MDR-TB and XDR-TB cases under expert guidance
- Contributes to reduced community transmission of drug-resistant TB through successful treatment
Common use
Trecator SC is primarily used as part of a combination regimen for multidrug-resistant tuberculosis (MDR-TB), defined as resistance to at least isoniazid and rifampin. It may also be incorporated into regimens for extensively drug-resistant tuberculosis (XDR-TB) or when patients cannot tolerate first-line agents due to adverse effects. Treatment always occurs under direct supervision of a physician experienced in managing drug-resistant tuberculosis, typically in consultation with public health authorities. Therapy duration typically ranges from 18–24 months depending on regimen composition and clinical response.
Dosage and direction
Adults: 15–20 mg/kg/day orally, usually divided into 2–3 daily doses. Maximum daily dose should not exceed 1 g. Dosing often starts at 250 mg once daily, gradually increasing to minimize gastrointestinal intolerance.
Pediatric patients: 15–20 mg/kg/day in divided doses, not to exceed 1 g/day.
Administration with food may reduce gastrointestinal upset. Tablets may be crushed and mixed with food or liquid if swallowing is difficult. Dosage must be adjusted in patients with severe hepatic impairment. Always administer as part of a combination regimen with at least three other drugs to which the mycobacterium is susceptible.
Precautions
- Hepatic function should be monitored before initiation and regularly during therapy due to risk of hepatotoxicity
- Periodic ophthalmologic examinations recommended as ethionamide may cause optic neuritis
- Blood glucose should be monitored as ethionamide may cause hypoglycemia
- Use with caution in patients with diabetes mellitus, thyroid disorders, or porphyria
- Psychiatric symptoms including depression, psychosis, and hallucinations may occur
- Peripheral neuropathy may develop; pyridoxine (vitamin B6) supplementation is recommended
- Pregnancy Category C: Use only if potential benefit justifies potential risk to fetus
Contraindications
- Hypersensitivity to ethionamide or any component of the formulation
- Severe hepatic impairment or active hepatitis
- Combination with cycloserine in patients with history of epilepsy or psychiatric disorders
- Use as monotherapy for any form of tuberculosis
- History of severe hypersensitivity reactions to related compounds (isoniazid, pyrazinamide)
Possible side effects
Common (≥1%): Gastrointestinal disturbances (nausea, vomiting, abdominal pain, metallic taste), dizziness, psychiatric symptoms (depression, anxiety), peripheral neuropathy, visual disturbances, hypersalivation.
Less common (<1%): Hepatotoxicity (elevated transaminases, jaundice), orthostatic hypotension, gynecomastia, impotence, menstrual irregularities, acne, photosensitivity, hypoglycemia, hypothyroidism, alopecia.
Rare: Severe hepatitis, optic neuritis, seizures, toxic epidermal necrolysis.
Drug interaction
- Alcohol: Increased risk of hepatotoxicity and CNS effects
- Cycloserine: Increased risk of CNS toxicity and seizures
- Isoniazid: Increased risk of hepatotoxicity and peripheral neuropathy
- Rifampin: May decrease ethionamide concentrations
- Oral hypoglycemics/Insulin: Enhanced hypoglycemic effect
- Phenytoin: Possible increased phenytoin levels
- Disulfiram: Potential for psychotic reactions
- Vitamin B6 (pyridoxine): May help prevent neuropathy
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed one. Maintain regular dosing schedule to ensure consistent therapeutic levels. Inform healthcare provider of missed doses, particularly in directly observed therapy (DOT) programs.
Overdose
Symptoms may include severe nausea, vomiting, dizziness, hypotension, hypoglycemia, and CNS depression. There is no specific antidote. Treatment is supportive and symptomatic, including gastric lavage if presented early, maintenance of blood pressure, correction of hypoglycemia, and monitoring of hepatic function. Hemodialysis may be of limited benefit due to high protein binding.
Storage
Store at controlled room temperature (20–25°C or 68–77°F). Protect from light and moisture. Keep in original container with lid tightly closed. Keep out of reach of children and pets. Do not use after expiration date printed on packaging.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances. Dosage and administration may vary based on specific clinical situation, resistance patterns, and treatment guidelines. Always follow the prescribed regimen and report any adverse effects to your healthcare provider promptly.
Reviews
“Trecator SC remains an essential component of our MDR-TB armamentarium despite its side effect profile. When used appropriately in combination regimens with careful monitoring, it contributes significantly to treatment success in complex cases.” — Infectious Disease Specialist, TB Reference Center
“While gastrointestinal side effects are challenging, dose escalation and administration with food improve tolerance. The drug’s ability to penetrate the CNS makes it invaluable for tuberculous meningitis with resistant organisms.” — Clinical Pharmacist, TB Program
“Managing ethionamide therapy requires vigilance for both hepatic and neuropsychiatric effects, but it fills a critical gap in MDR-TB treatment when fluoroquinolones or injectables cannot be used.” — Pulmonologist, Multidrug-Resistant TB Clinic