Adult Dosing

Treatment of active tuberculosis

• 15-20 mg/kg PO daily
• Start 250 mg PO daily x 1-2 days, followed by 250 mg twice daily x 1–2 days, with a gradual increase to 1 g daily divided tid-qid, use lowest effective dose
• Max dose: 1 g/day

Note:

• Ethionamide is not used as first line of therapy; it is a part of multi-drug regimen. Give with food

Pediatric Dosing

Treatment of active tuberculosis

• 2-15 yrs: 15-20 mg/kg/day PO in divided doses with food. Start with 250 mg PO daily for 1-2 days, then 250 mg twice daily for 1-2 days; Max: 750 mg/day
• >15 yrs: 500-750 mg PO daily in divided doses with food. Start: 250 mg PO daily for 1-2 days, then 250 mg twice daily for 1-2 days; Max: 750 mg/day

Note:

• Ethionamide is not used as first line of therapy; it is a part of multi-drug regimen. Give with food

• Treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, in combination with other another anti tuberculosis drug to which the M. tuberculosis is known to be susceptible

• Hypersensitivity to any ingredients of the product
• Severe hepatic impairment

• N/A

Renal Dose Adjustment (Based on CrCl)

• <10 mL/min: Reduce dose by 50%

Hepatic Dose Adjustment

• Severe impairment: Contraindicated

See Supplemental Patient Information

• Ethionamide should be used in conjunction with other antitubercular agents to avoid the development of resistance. It should be combined with one or two drugs to which the organism is known to be susceptible such as rifampin, ethambutol, pyrazinamide, cycloserine, kanamycin, streptomycin and isoniazid
• Patient should adhere to the regime until treatment is complete, in order to prevent the emergence of drug resistant organism
• When patient develop drug-resistant to organisms, additional consultation from experts is recommended
• Ethionamide may potentiate the adverse effects of the other antituberculous drugs, administered concomitantly
• Monitor LFTs at baseline, then every month, temporarily withhold the treatment if serum transaminases become elevated and then reintroduce sequentially to determine which drug is responsible for the hepatotoxicity
• Hypothyroidism, with or without goiter, has been reported with ethionamide therapy, monitor thyroid function test periodically
• Monitor creatinine, platelet count and glucose at baseline, then every month; perform ophthalmic examinations at baseline, then periodically

Cautions: Use cautiously in

• Hypothyroidism
• Diabetes mellitus

Supplemental Patient Information

• Advise patient to consult the physician if blurred vision or any loss of vision, with or without eye pain, occur during treatment
• Advise patients to avoid excessive ethanol ingestion as it may cause psychotic reaction

Pregnancy Category:C

Breastfeeding: Minimal information available regarding the use of ethionamide during breastfeeding. As mother of the infants, who showed developmental problem when exposed to ethionamide in breast milk, were also exposed to several other drugs during pregnancy and breastfeeding the problems cannot necessarily be attributed to ethionamide, It is not a reason to discontinue breastfeeding when ethionamide is required by the mother of an older infant, however an alternate drugs may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 February 2011). As per manufacture data, it should be administer only if the benefits outweigh the risks. Monitor adverse reaction.

• GI: GI disturbance, nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia and weight loss
• CNS: Psychotic disturbances, drowsiness, dizziness, restlessness, headache, postural hypotension
• HEPA: Increases in serum bilirubin, SGOT, SGPT, hepatitis, jaundice
• EENT: Visual change, blurred vision
• HEMA: Thrombocytopenia
• METABOLIC: Hypoglycemia, hypothyroidism
• DERM: Acne, rash, alopecia, photosensitivity
• GU: Gynecomastia, impotence
• MISC: Hypersensitivity reactions

• Antituberculosis agent; bacteriostatic or bactericidal in action, inhibits the synthesis of peptide in susceptible organisms
• Well absorbed following oral administration
• Extensively metabolized by liver to active metabolites and inactive metabolites
• Renally excreted (<1% unchanged)
• Half-life: 1.92 hrs

US Trade Name(s)

• Trecator

US Availability

Trecator

• TABS: 250 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Antimicrobials

Antituberculosis Agents

Nicotinic Acid Derivatives

Infectious Disease

Antituberculosis Agents

Nicotinic Acid Derivatives

Drug Name: Trecator 250 MG Oral Tablet

Ingredient(s): Ethionamide

Imprint: W;4117

Color(s): Orange

Shape: Round

Size (mm): 12.00

Score: 1

Inactive Ingredient(s): croscarmellose sodium / fd&c yellow no. 6 / magnesium stearate / cellulose, microcrystalline / polyethylene glycol / polyvinyl alcohol / povidone / silicon dioxide / talc / titanium dioxide

Drug Label Author:
Wyeth Pharmaceuticals Company

DEA Schedule:
Non-Scheduled