TRECATOR- ethionamide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHIONAMIDE (UNII: OAY8ORS3CQ) (ETHIONAMIDE - UNII:OAY8ORS3CQ)

Available from:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

ETHIONAMIDE

Composition:

ETHIONAMIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trecator is primarily indicated for the treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs. Its use alone in the treatment of tuberculosis results in the rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility tests. If the susceptibility tests indicate that the patient's organism is resistant to one of the first-line anti-tuberculosis drugs (i.e., isoniazid or rifampin) yet susceptible to ethionamide, ethionamide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to be susceptible.3 If the tuberculosis is resistant to both isoniazid and rifampin, yet susceptible to ethionamide, ethionamide should be accompanied by at least two other drugs to which the M. tuberculosis isolate is known to be susceptible.3 To reduce the development of drug-resista

Product summary:

Trecator® (ethionamide tablets, USP) are supplied in bottles of 100 tablets as follows: 250 mg, orange film-coated tablet marked "W" on one side and "4117" on reverse side, NDC 0008-4117-01. Store at controlled room temperature 20 ° to 25 °C (68 ° to 77 °F). Dispense in a tight container.

Authorization status:

New Drug Application

Summary of Product characteristics

TRECATOR- ETHIONAMIDE TABLET, FILM COATED
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
----------
TRECATOR
(ETHIONAMIDE TABLETS, USP)
TABLETS
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Trecator and other antibacterial drugs, Trecator should be used only
to treat infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Trecator
(ethionamide tablets, USP) is used in the treatment of tuberculosis.
The
chemical name for ethionamide is 2-ethylthioisonicotinamide with the
following structural
formula:
C8H10N2S M.W. 166.24
Ethionamide is a yellow crystalline, nonhygroscopic compound with a
faint to moderate
sulfide odor and a melting point of 162°C. It is practically
insoluble in water and ether,
but soluble in methanol and ethanol. It has a partition coefficient
(octanol/water) Log P
value of 0.3699. Trecator tablets contain 250 mg of ethionamide. The
inactive
ingredients present are croscarmellose sodium, FD&C Yellow #6,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
povidone, silicon dioxide,
talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
ABSORPTION
Ethionamide is essentially completely absorbed following oral
administration and is not
subjected to any appreciable first pass metabolism. Ethionamide
tablets may be
administered without regard to the timing of meals.
The pharmacokinetic parameters of ethionamide following single
oral-dose administration
of 250 mg of Trecator film-coated tablets under fasted conditions to
40 healthy adult
volunteers are provided in Table 1.
®
®
TABLE 1: MEAN (SD) PHARMACOKINETIC PARAMETERS FOR
ETHIONAMIDE FOLLOWING SINGLE-DOSE ADMINISTRATION OF 250 MG
TRECATOR FILM-COATED TABLETS TO HEALTHY ADULT VOLUNTEERS
C
(ΜG/ML)
T
(HRS)
AUC
(ΜG∙HR/ML)
Film-Coated Tablet
2.16
(0.61)
1.02
(0.55)
7.67
(1.69)
Trecator tablets have been reformulated from a sugar-coated tablet to
a film-coated
tablet. The C
for the film-coated tablets (2.16 µg/mL) was significantly higher