Ethomid Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Ethionamide

Indications/Uses

In combination w/ other anti-TB agents in the treatment of clinical TB. 2nd-line anti-TB agent for the treatment of drug-resistant TB caused by Mycobacterium tuberculosis known or presumed to be susceptible to the drug, especially when INH &/or rifampin cannot be used because of resistance &/or intolerance.

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Dosage/Direction for Use

Adult In combination w/ other anti-TB agents for active TB 15-20 mg/kg daily as single or in divided doses. Initial dose: 250 mg daily w/ gradual titration to optimal dosage based on patient tolerance. Max: 1 g/day. Ped 10-20 mg/kg daily in 2 or 3 divided doses or 15 mg/kg once daily. Renal impairment (CrCl <30 mL/min) & those undergoing hemodialysis Reduced dose of 250-500 mg daily. Duration: 6 mth (2 mth initial intensive phase & 4-7 mth continuation phase).

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Overdosage

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Administration

Adult: May be taken with or without food. Ped: Should be taken with food.

Contraindications

Hypersensitivity. Severe hepatic impairment.

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Special Precautions

Hypersensitivity reactions including rash, photosensitivity, thrombocytopenia & purpura. Temporarily discontinue treatment if serum transaminases become elevated. Reintroduce ethionamide & concomitant anti-TB drugs sequentially to determine which drug is responsible for hepatotoxicity. Determine serum AST (SGOT) & ALT (SGPT) conc prior to & at mthly intervals; blood glucose conc prior to & periodically during treatment. Periodically monitor thyroid function tests (eg, at baseline & at mthly intervals). Rapid development of resistance if used alone. Diabetic patients should be particularly alert for hypoglycaemic episodes. Avoid in patients w/ severe hepatic impairment. Caution in patients w/ less severe hepatic impairment. Pregnancy. Lactation; monitor infant for adverse effects.

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Use In Pregnancy & Lactation

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Adverse Reactions

Psychotic disturbances (including mental depression), drowsiness, dizziness, restlessness, headache, postural hypotension; nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia, wt loss; transient increases in serum bilirubin, AST, ALT, hepatitis (w/ or w/o jaundice); rash, photosensitivity, thrombocytopenia, purpura; hypoglycemia, gynecomastia, impotence, acne.

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Drug Interactions

Psychotic reaction w/ excessive alcohol. Increased serum conc of INH. May potentiate the adverse effects of other anti-TB agents. Additive adverse nervous system effects w/ cycloserine & INH.

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Storage

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Description

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Action

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MIMS Class

Anti-TB Agents

ATC Classification

J04AD03 - ethionamide ; Belongs to the class of thiocarbamide derivatives. Used in the systemic treatment of tuberculosis.

Thai FDA Category

Presentation/Packing

Form

Ethomid FC tab 250 mg

Packing/Price

1 × 10's

Ethomid

ethionamide

Manufacturer:

Macleods Pharmaceuticals

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare