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Ethionamide is authorised in the world under the following brand names: Aethionamidum, Aetina, Aetiva, Amidazin, Amidazine, Atina, Bayer 5312, Ethimide, Ethina, Etimid, Etiocidan, Etionid, Etionizin, Etionizina, Etionizine, Fatoliamid, Iridocin, Iridozin, Isothin, Isotiamida, Itiocide, Nicotion, Nisotin, Nizotin, Rigenicid, Sertinon, Teberus, Thianid, Thianide, Thioamide, Thiomid, Thioniden, Tianid, Tio-Mid, Tiomid, Trecator, Trecator-SC, Trekator, Trescatyl, Trescazide, Tubenamide, Tubermin, Tuberoid, Tuberoson.

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Ethionamide is a synthetic, isonicotinic acid-derivative antituberculosis agent.



Active Tuberculosis

Ethionamide is used in conjunction with other antituberculosis agents in the treatment of clinical tuberculosis.

The American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) currently recommend several possible multiple-drug regimens for the treatment of culture-positive pulmonary tuberculosis. These regimens have a minimum duration of 6 months (26 weeks), and consist of an initial intensive phase (2 months) and a continuation phase (usually either 4 or 7 months).


Ethionamide is considered a second-line antituberculosis agent for use in these regimens. The drug usually is used in the treatment of drug-resistant tuberculosis caused by Mycobacterium tuberculosis known or presumed to be susceptible to the drug, especially when isoniazid and/or rifampin cannot be used because of resistance and/or intolerance. If ethionamide is added as a new drug to a regimen in patients experiencing treatment failure who have proven or suspected drug-resistant tuberculosis, at least 2, preferably 3, new drugs known or expected to be active against the resistant strain should be added at the same time.

After results of in vitro susceptibility testing are available, the regimen can be adjusted accordingly. For information on general principles used in the treatment of tuberculosis, see the Antituberculosis Agents General Statement 8:16.04.

Other Mycobacterial Infections

Ethionamide has been used in conjunction with other antituberculosis or anti-infective agents in the treatment of Mycobacterium avium complex (MAC) infections. Some clinicians suggest that ethionamide be included in one alternative multiple-drug regimen for the treatment of MAC pulmonary infections in patients whose disease has failed to respond to therapy with a macrolide-containing regimen (e.g., clarithromycin or azithromycin, rifabutin or rifampin, and ethambutol). In such patients, subsequent therapy is complicated, may be associated with a high incidence of adverse effects, and should be undertaken only under the guidance of clinicians experienced in handling these patients.

Although ethionamide has been used in the treatment of multibacillary leprosy and previously was recommended as an alternative agent for use in multiple-drug regimens in patients who would not accept or could not tolerate clofazimine, the World Health Organization (WHO) no longer recommends use of ethionamide for the treatment of leprosy because severe hepatotoxicity has been associated with use of the drug.

The WHO and most clinicians currently recommend that multibacillary leprosy be treated with a multiple-drug regimen that includes rifampin, dapsone, and clofazimine, and that paucibacillary leprosy be treated with a multiple-drug regimen that includes rifampin and dapsone. If an alternative agent is needed for these regimens in patients who will not accept or cannot tolerate clofazimine or in patients who cannot receive rifampin because of adverse effects, intercurrent disease (e.g., chronic hepatitis), or infection with rifampin-resistant M. leprae, the WHO and other clinicians generally recommend use of ofloxacin and minocycline.


Ethionamide is administered orally.

If the drug is given as a single daily dose, the dose should be given at the time of day that the patient finds most suitable in order to avoid or minimize GI intolerance, which usually is at mealtimes.


Active Tuberculosis

In the treatment of clinical tuberculosis, ethionamide should not be given alone. The drug is considered a second-line agent for use in daily multiple-drug regimens for the treatment of active tuberculosis. Data are not available to date regarding use of ethionamide in intermittent multiple-drug regimens used in the treatment of tuberculosis. Therapy for tuberculosis should be continued long enough to prevent relapse. The minimum duration of treatment currently recommended for patients with culture-positive pulmonary tuberculosis is 6 months (26 weeks), and recommended regimens consist of an initial intensive phase (2 months) and a continuation phase (usually either 4 or 7 months). However, completion of treatment is determined more accurately by the total number of doses and is not based solely on the duration of therapy.

Adult Dosage

The manufacturer states that the usual adult dosage of ethionamide for use in conjunction with other antituberculosis agents for the treatment of tuberculosis is 15-20 mg/kg (up to 1 g) daily. The drug may be administered once daily or, if GI intolerance occurs, in divided doses. The manufacturer states that initiation of therapy with a dosage of 250 mg daily, with gradual titration to optimal dosage as tolerated by the patient, also may be beneficial. A regimen consisting of ethionamide 250 mg daily for 1-2 days, followed by 250 mg twice daily for 1-2 days with a subsequent increase to 1 g daily in 3 or 4 divided doses, has been used.

The American Thoracic Society (ATS), US Centers for Disease Control (CDC), and Infectious Diseases Society of America (IDSA) state that the usual dosage of ethionamide for use in conjunction with other antituberculosis agents in adults and children 15 years of age or older is 15-20 mg/kg (up to 1 g) daily; a dosage of 500-750 mg daily usually is recommended given as a single daily dose or in 2 divided doses.

Pediatric Dosage

The manufacturer states that optimum dosage for children has not been established. However, the ATS, CDC, IDSA, and American Academy of Pediatrics (AAP) recommend a pediatric dosage of 15-20 mg/kg (up to 1 g) daily given in 2 or 3 divided doses. Limited evidence suggests that an ethionamide dosage of 20 mg/kg daily given as a single dose in children is more likely to produce CSF concentrations exceeding the minimum inhibitory concentration of 2.5 mcg/mL for Mycobacterium tuberculosis.


GI Effects

GI disturbances are the most frequent adverse effects of ethionamide. Adverse GI effects of the drug include nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia, and weight loss. Adverse GI effects appear to be dose related, with approximately 50% of patients being unable to tolerate a single dose of 1 g. Adverse GI effects may be minimized by decreasing the dosage, changing the time of drug administration, or administering concomitant antiemetic therapy. Some patients tolerate ethionamide best when it is administered in a single dose at bedtime; others tolerate the drug best when it is administered in equally divided doses with meals. Nausea and vomiting may be severe enough to necessitate discontinuance of ethionamide.

Nervous System and Special Senses Effects

Psychotic disturbances, mental depression, restlessness, drowsiness, dizziness, headache, postural hypotension, and asthenia occur occasionally with ethionamide. Rarely, peripheral neuritis, paresthesia, seizures, tremors, a pellagra-like syndrome, hallucinations, diplopia, optic neuritis, blurred vision, and olfactory disturbances have been reported. Neurotoxic effects may be prevented or relieved by the concomitant administration of pyridoxine hydrochloride.

Hepatic Effects

Transient increases in serum bilirubin, AST (SGOT), and ALT (SGPT) concentrations have been reported in patients receiving ethionamide. Hepatitis (with or without jaundice) has also been reported, especially in patients with diabetes mellitus. Hepatotoxicity generally is reversible on discontinuance of the drug.

Other Adverse Effects

Hypersensitivity reactions including rash, photosensitivity, thrombocytopenia, and purpura have been reported rarely with ethionamide. Goiter, with and without hypothyroidism, has also been associated rarely with ethionamide therapy. Hypoglycemia, gynecomastia, impotence, menorrhagia, joint pain, acute rheumatic symptoms, and acne have also occurred. The management of patients with diabetes mellitus may become more difficult in those receiving ethionamide.

Precautions and Contraindications

Ethionamide is contraindicated in patients with severe hepatic impairment and in patients who are hypersensitive to the drug.

Serum AST (SGOT) and ALT (SGPT) concentrations should be determined prior to and every 4 weeks during ethionamide therapy. If serum aminotransferases (transaminases) become elevated during therapy with ethionamide, ethionamide and the concomitant antituberculosis drugs may be discontinued temporarily until the laboratory abnormalities resolve. Ethionamide and concomitant antituberculosis drugs should then be reintroduced sequentially to determine which drug(s) are responsible for the hepatotoxicity.

Ophthalmologic examinations (including ophthalmoscopy) should be performed prior to and periodically during therapy with ethionamide. Patients should be advised to consult their clinician if blurred vision or any loss of vision, with or without ocular pain, occurs during ethionamide therapy.

Blood glucose determinations should be performed prior to and periodically during therapy with ethionamide. In particular, diabetic patients should be alert for episodes of hypoglycemia.

Periodic monitoring of thyroid function tests is recommended as hypothyroidism, with or without goiter, has been reported during ethionamide therapy.

Pediatric Precautions

Limited information is available on the use of ethionamide in neonates, infants, and children. The manufacturer states that the drug should not be used in children younger than 12 years of age except when the infection being treated is definitely resistant to first-line therapy and systemic dissemination of the disease or other life-threatening complications of tuberculosis are judged to be imminent.

Pregnancy and Lactation

Safe use of ethionamide during pregnancy has not been established. The drug has caused teratogenic effects in rabbits and rats when administered in high doses. There are no adequate and controlled studies to date using ethionamide in pregnant women, and the manufacturer states that the drug should not be used in women who are or may become pregnant unless the clinicians considers the drug essential to treatment. The American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) state that ethionamide should not be used during pregnancy since it crosses the placenta and is teratogenic in animals.

The effect of ethionamide on labor and delivery in pregnant women is unknown.

Because it is not known whether ethionamide is distributed into human milk, ethionamide should be administered to nursing mothers only if the benefits of therapy outweigh the potential risks to the infant. The manufacturer states that if ethionamide is administered during breastfeeding, the infant should be monitored for adverse effects.

Drug Interactions

Antituberculosis Agents

Serum concentrations of isoniazid reportedly may increase temporarily during concomitant ethionamide therapy. There is some evidence that adverse nervous system effects of ethionamide, cycloserine, and isoniazid may be additive; seizures have been reported in patients receiving concomitant therapy with ethionamide and cycloserine. Therefore, ethionamide should be used with caution in patients receiving cycloserine or isoniazid.

Excessive ingestion of alcoholic beverages should be avoided in patients taking ethionamide because of a reported psychotic reaction associated with this situation.

Mechanism of Action

Ethionamide may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. The exact mechanism of action of ethionamide has not been fully elucidated, but the drug appears to inhibit peptide synthesis in susceptible organisms.


Ethionamide is a highly specific agent and is active only against organisms of the genus Mycobacterium. Ethionamide is active in vitro and in vivo against M. tuberculosis, M. bovis, M. kansasii, and some strains of M. avium and M. intracellulare. The drug is also active against M. leprae in experimental leprosy in mice. In vitro, the minimum inhibitory concentration (MIC) of ethionamide for most susceptible mycobacteria is 0.6-10 mcg/mL.


Natural and acquired resistance to ethionamide have been demonstrated in vitro and in vivo in strains of M. tuberculosis. Resistant strains of initially susceptible M. tuberculosis develop rapidly if ethionamide is used alone in the treatment of clinical tuberculosis. When ethionamide is combined with other antituberculosis agents in the treatment of the disease, emergence of resistant strains may be delayed or prevented. There is no evidence of cross-resistance between ethionamide and other antituberculosis agents currently available in the US.

Strains of M. leprae resistant to ethionamide have been reported rarely.



Approximately 80% of an oral dose of ethionamide is rapidly absorbed from the GI tract. Following a single 1-g oral dose in adults, peak plasma concentrations of ethionamide averaging 20 mcg/mL are attained within 3 hours; plasma concentrations of the drug average 3 mcg/mL at 9 hours and less than 1 mcg/mL at 24 hours. Following a single 250-mg oral dose in healthy adults, peak plasma concentrations of ethionamide of about 2 mcg/mL generally were attained at 2 hours. Serum ethionamide concentrations 2 hours after doses of 250-500 mg of the drug generally average 1-5 mcg/mL.


Ethionamide is widely distributed into body tissues and fluids; concentrations in plasma and various organs are approximately equal. The drug is about 30% bound to plasma proteins. The concentration of ethionamide in CSF is reported to be equal to concurrent plasma concentrations of the drug in patients with normal or inflamed meninges. In a study in children with tuberculous meningitis, peak concentrations of ethionamide in CSF generally occurred 1.5-2.5 hours after oral doses of 15 or 20 mg/kg but showed considerable interindividual and intraindividual variation. Ethionamide readily crosses the placenta. It is not known if ethionamide is distributed into milk.


The plasma half-life of ethionamide is approximately 2-3 hours.

Ethionamide is extensively metabolized to active and inactive metabolites, probably in the liver. The major active metabolite is the sulfoxide, which may be converted back to ethionamide in vivo. Within 24 hours, 1-5% of an oral dose of ethionamide is excreted in urine as active drug and metabolites; the remainder is excreted in urine as inactive metabolites.

Chemistry and Stability


Ethionamide is a synthetic, isonicotinic acid-derivative antituberculosis agent. The drug occurs as a bright yellow, crystalline powder with a faint to moderate sulfide-like odor and is slightly soluble in water and sparingly soluble in alcohol.


Ethionamide tablets should be stored in well-closed containers at 20-25┬░C.



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Synonyms of Ethionamide:

ET, ETH, Ethinamide, Ethionamid Prothionamid, Ethionamidum [INN-Latin], Ethioniamide, Ethylisothiamide, Ethyonomide, Etionamid, Etionamida [INN-Spanish], Etionamide [DCIT], Etioniamid, ETP

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Therapeutic classes of Ethionamide:

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