Ethionamide

Ethionamide is a prescription medication used for the treatment of active tuberculosis in patients with Mycobacterium tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs.

• Ethionamide is available under the following different brand names: Trecator

Common side effects of Ethionamide include:

• nausea
• vomiting
• diarrhea
• abdominal or stomach pain
• increased salivation
• metallic taste in the mouth
• loss of appetite
• sores in the mouth
• unusual fatigue or weakness
• headache
• dizziness
• tremors (shaking)
• rash

Serious side effects of Ethionamide include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• numbness, tingling, or burning pain in the hands or feet
• confusion; unusual thoughts or behavior
• eye pain, blurred vision, double vision
• a light-headed feeling
• seizures (convulsions)
• upper stomach pain, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes)

Rare side effects of Ethionamide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 250 mg

Tuberculosis, active

Adult dosage

• 15-20 mg/kg/day orally
• Initiate dose at 250 mg/day for 1-2 days; then increase to 250 mg twice daily for 1-2 days with gradual increases to highest tolerated dose; 750 mg/day average dose
• Not to exceed 1000 mg/day in 3-4 divided doses

Pediatric dosage

• 10-20 mg/kg/day divided two times a day/three times a day orally, or
• 15 mg/kg orally once a day
• No more than 1000 mg/day in 3-4 divided doses

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Ethionamide has severe interactions with no other drugs.
• Ethionamide has serious interactions with no other drugs.
• Ethionamide has moderate interactions with the following drugs:
  • cycloserine
  • isoniazid
  • sodium picosulfate/magnesium oxide/anhydrous citric acid
• Ethionamide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to ethionamide
• Severe hepatic dysfunction

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ethionamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ethionamide?”

Cautions

• Use caution in diabetes mellitus, thyroid disease, hepatic impairment
• HIV patients may have malabsorption syndrome
• Ethionamide when used as monotherapy in the treatment of tuberculosis results in the rapid development of resistance; give suitable companion drug or drugs based on the result of susceptibility testing; therapy may be initiated before receiving the result of susceptibility tests as deemed appropriate by a physician; administer with at least one, sometimes two, other drugs to which organism is known to be susceptible
• Cases of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, reported with the use of combinations of antituberculosis drugs including Ethionamide; if symptoms or signs of SCARs develop, discontinue suspect drug(s) immediately and institute appropriate therapy
• Prescribing a drug in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and may increase the risk for the development of drug-resistant bacteria
• Ethionamide may potentiate adverse effects of other antituberculosis drugs administered concomitantly
• Perform ophthalmologic examinations (including ophthalmoscopy) before and periodically during therapy
• Excessive ethanol ingestion should be avoided; psychotic reactions reported

Pregnancy and Lactation

• There are no adequate and well-controlled studies on the drug’s use in pregnant women
• Effect of therapy on labor and delivery in pregnant women is unknown
• Lactation
  • Because no information is available on the excretion of ethionamide in human milk, therapy should be administered to nursing mothers only if the benefits outweigh the risks; newborns who are breastfed by mothers receiving ethionamide should be monitored for adverse effects