TRECATOR Dosage & Rx Info | Uses, Side Effects

Trecator Generic Name & Formulations

Legal Class

General Description

Ethionamide 250mg; tabs.

How Supplied

Tabs—100

Manufacturer

Pfizer Inc.

Generic Availability

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.

Trecator Indications

Indications

Adjunct in tuberculosis, when INH and rifampin are not appropriate.

Trecator Dosage and Administration

Adult

Give with meals to minimize GI upset. Initially 250mg/day in 1–4 divided doses; titrate to highest tolerated dose (see full labeling). Usual range: 15–20mg/kg daily; max 1g/day.

Children

Give with meals to minimize GI upset. 10–20mg/kg in 2–3 divided doses, or 15mg/kg once daily.

Trecator Contraindications

Contraindications

Severe hepatic impairment.

Trecator Boxed Warnings

Not Applicable

Trecator Warnings/Precautions

Warnings/Precautions

Confirm presence of susceptible bacterial infection before initiating therapy. Re-titrate when switching from Trecator SC sugar-coated tabs. Give with pyridoxine. Discontinue if severe cutaneous adverse reactions develop; treat appropriately. Diabetes. Do baseline and periodic blood glucose levels, eye exams (including ophthalmoscopy). Monitor thyroid function. Obtain SGOT and SGPT before and monthly; suspend if levels increase. Pregnancy: not recommended. Nursing mothers.

Trecator Pharmacokinetics

Absorption

Time to reach mean (SD) maximum plasma concentration after administration: 1.02 (0.55) hours. Maximum mean (SD) plasma concentration: 2.16 (0.61).

Distribution

Rapidly and widely distributed into body tissues and fluids. Plasma protein bound: ~30%. Mean (SD) apparent oral volume of distribution: 93.5 (19.2) L.

Metabolism

Hepatic.

Elimination

Mean (SD) Half-life: 1.92 (0.27) hours.

Trecator Interactions

Interactions

Avoid alcohol. Potentiates other antituberculars. Convulsions with cycloserine.

Trecator Adverse Reactions

Adverse Reactions

GI upset, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia, liver dysfunction, psychosis, drowsiness, dizziness, restlessness, headache, postural hypotension, hypoglycemia, gynecomastia, impotence, acne; rarely; peripheral/optic neuritis, visual disturbances, pellagra, thrombocytopenia, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).

Trecator Clinical Trials

See Literature

Trecator Note

Notes

Trecator tablets have been reformulated from a sugar-coated tablet to a film-coated tablet which may result in higher peak levels.

Trecator Patient Counseling