Trecator SC (ethionamide) is a second-line antituberculosis agent specifically formulated for the treatment of active pulmonary and extrapulmonary tuberculosis when first-line therapies are ineffective or not tolerated. As a critical component of multidrug regimens, it targets Mycobacterium tuberculosis through a unique mechanism of action, inhibiting mycolic acid synthesis essential for bacterial cell wall integrity. This medication is reserved for cases of drug-resistant TB or when patients exhibit contraindications to primary treatments, underscoring its specialized role in complex clinical scenarios. Proper administration under strict medical supervision is imperative to maximize therapeutic outcomes and minimize resistance development.

Features

• Contains ethionamide as the active pharmaceutical ingredient
• Available in 250 mg film-coated tablets for precise dosing
• Manufactured under current Good Manufacturing Practices (cGMP)
• Requires prescription and medical supervision for use
• Compatible with most second-line anti-TB drug regimens
• Stable at room temperature with appropriate storage conditions

Benefits

• Effectively targets drug-resistant strains of Mycobacterium tuberculosis when first-line treatments fail
• Disrupts bacterial cell wall synthesis through inhibition of mycolic acid production
• Provides critical therapeutic option for both pulmonary and extrapulmonary tuberculosis infections
• Enables tailored combination therapy approaches for complex TB cases
• Helps prevent disease progression and transmission in resistant infections
• Supports completion of TB eradication protocols when standard medications are contraindicated

Common use

Trecator SC is primarily indicated for the treatment of active tuberculosis in combination with other antituberculosis drugs. It is specifically employed when patients cannot tolerate first-line medications or when infection involves drug-resistant strains of Mycobacterium tuberculosis. The medication finds application in both pulmonary tuberculosis and various forms of extrapulmonary tuberculosis, including lymphatic, genitourinary, and skeletal system infections. Clinical use is typically reserved for cases where susceptibility testing confirms ethionamide sensitivity or when treatment options are limited due to resistance patterns.

Dosage and direction

The recommended adult dosage is 15-20 mg/kg/day, typically administered as 250 mg to 1 g daily, divided into 3-4 equal doses. Dosing should be initiated at lower levels and gradually increased to minimize gastrointestinal adverse effects. The maximum daily dose should not exceed 1 g. Administration with food may improve tolerance to gastrointestinal side effects. Pediatric dosing is based on 15-20 mg/kg/day in divided doses, not to exceed 1 g daily. Treatment duration typically continues for 12-24 months depending on disease severity and treatment response, always in combination with other antituberculosis medications as determined by susceptibility testing.

Precautions

Hepatic function should be monitored regularly throughout therapy, as ethionamide may cause hepatotoxicity. Baseline and periodic liver enzyme tests are recommended. Patients should be advised that neurotoxic effects, including peripheral neuropathy, may occur and supplementation with pyridoxine (vitamin B6) is often prescribed prophylactically. Regular ophthalmologic examinations are advised due to potential visual disturbances. Use with caution in patients with diabetes mellitus, as ethionamide may interfere with diabetes control. Alcohol consumption should be avoided during treatment due to increased risk of hepatotoxicity and central nervous system effects.

Contraindications

Trecator SC is contraindicated in patients with known hypersensitivity to ethionamide or any component of the formulation. Severe hepatic impairment or active liver disease represents an absolute contraindication due to the drug’s hepatotoxic potential. The medication should not be used in patients with severe malnutrition or porphyria. Concomitant use with certain psychotropic medications that lower seizure threshold is contraindicated. Pregnancy represents a relative contraindication unless the potential benefit justifies the potential risk to the fetus, as animal studies have demonstrated teratogenic effects.

Possible side effect

Gastrointestinal disturbances are most frequently reported, including nausea (approximately 50% of patients), vomiting, abdominal pain, diarrhea, and metallic taste. Neurological effects may include peripheral neuropathy, dizziness, headache, and rarely, seizures. Psychiatric manifestations such as depression, anxiety, and hallucinations have been documented. Hepatotoxicity ranging from elevated transaminases to clinical hepatitis occurs in approximately 5% of patients. Endocrinological effects include hypothyroidism, gynecomastia, and menstrual irregularities. Dermatological reactions including photosensitivity, acne, and alopecia may occur. Visual disturbances and optic neuritis represent rare but serious adverse effects.

Drug interaction

Concurrent administration with cycloserine may increase neurotoxic effects. Ethionamide may potentiate the effects of antidiabetic medications, requiring adjustment of hypoglycemic therapy. concomitant use with other hepatotoxic drugs, including isoniazid, pyrazinamide, and rifampin, increases the risk of liver damage. The medication may reduce the effectiveness of oral contraceptives, necessitating alternative contraceptive methods. Alcohol consumption significantly increases the risk of hepatotoxicity and central nervous system depression. Interaction with phenytoin may alter seizure threshold and require dosage adjustments.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling of doses to make up for missed doses is not recommended. Patients should maintain a consistent dosing schedule to ensure therapeutic drug levels are maintained. If multiple doses are missed, medical consultation is advised to assess potential impact on treatment efficacy and possible need for regimen adjustment.

Overdose

Symptoms of overdose may include severe nausea and vomiting, dizziness, headache, and possible neurotoxic effects including seizures. Hepatotoxicity may be exacerbated with excessive doses. There is no specific antidote for ethionamide overdose. Management consists of immediate gastric lavage if ingestion was recent, followed by supportive and symptomatic treatment. Activated charcoal may be administered if presented within one hour of ingestion. Hospitalization for observation and monitoring of hepatic and neurological status is recommended. Hemodialysis is not effective for ethionamide removal due to high protein binding.

Storage

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). Protect from light and moisture. Keep the container tightly closed when not in use. Do not store in bathroom areas where humidity levels may fluctuate. Keep out of reach of children and pets. Do not use beyond the expiration date printed on packaging. Properly dispose of any unused medication according to local regulations for pharmaceutical waste.

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 specific dosage recommendations and treatment duration. Patients should not alter their medication regimen without medical supervision. While every effort has been made to ensure accuracy, medical knowledge evolves and the most current prescribing information should always be consulted.

Reviews

Clinical studies demonstrate Trecator SC’s efficacy in multidrug-resistant tuberculosis treatment when used as part of appropriately designed regimens. The 2019 WHO guidelines on drug-resistant tuberculosis treatment recognize ethionamide as an important component of longer regimens for multidrug-resistant TB. Treatment success rates of 65-75% have been reported in studies combining ethionamide with other second-line drugs, though outcomes vary based on resistance patterns and patient adherence. Specialist physicians note that while side effects can be challenging, dose titration and supportive medications often enable successful treatment completion. The medication’s role continues to evolve with emerging data on shorter regimens for drug-resistant TB.