Ketek (Telithromycin) - Indications and Dosage

DOSAGE AND ADMINISTRATION

The dose of KETEK tablets is 800 mg (2 tablets of 400 mg) taken orally once every 24 hours, for 7–10 days. KETEK tablets can be administered with or without food.

KETEK may be administered without dosage adjustment in the presence of hepatic impairment.

In the presence of severe renal impairment (CL_CR < 30 mL/min), including patients who need dialysis, the dose should be reduced to KETEK 600 mg once daily. In patients undergoing hemodialysis, KETEK should be given after the dialysis session on dialysis days. (See CLINICAL PHARMACOLOGY, Renal insufficiency.)

In the presence of severe renal impairment (CL_CR < 30 mL/min), with coexisting hepatic impairment, the dose should be reduced to KETEK 400 mg once daily. (See CLINICAL PHARMACOLOGY, Multiple insufficiency.)

HOW SUPPLIED

KETEK^® 400 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "H3647" on one side and "400" on the other side. These are packaged in bottles and blister cards (Ketek Pak™ and unit dose) as follows:

Bottles of 60                                                                         (NDC 0088-2225-41)
Ketek Pak™, 10-tablet cards (2 tablets per blister cavity)     (NDC 0088-2225-07)
Unit dose package of 100 (blister pack)                                (NDC 0088-2225-49)

KETEK^® 300 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "38AV" on one side and blank on the other side. These are packaged in bottles as follows:

Bottles of 20                                                                         (NDC 0088-2223-20)

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].