Ketoconazole (Page 3 of 3)

OVERDOSAGE

In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.

DOSAGE AND ADMINISTRATION

Adults

The recommended starting dose of Ketoconazole Tablets is a single daily administration of 200 mg (one tablet). In very serious infections or if clinical responsiveness is insufficient within the expected time, the dose of Ketoconazole Tablets may be increased to 400 mg (two tablets) once daily.

Pediatric Patients

In small numbers of pediatric patients over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole Tablets have not been studied in pediatric patients under 2 years of age.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. Treatment should be continued until tests indicate that active fungal infection has subsided. Inadequate periods of treatment may yield poor response and lead to early recurrence of clinical symptoms. Minimum treatment for candidiasis is one or two weeks. Patients with chronic mucocutaneous candidiasis usually require maintenance therapy. Minimum treatment for the other indicated systemic mycoses is six months.

Minimum treatment for recalcitrant dermatophyte infections is four weeks in cases involving glabrous skin. Palmar and plantar infections may respond more slowly. Apparent cures may subsequently recur after discontinuation of therapy in some cases.

HOW SUPPLIED

Ketoconazole Tablets USP 200 mg are available as white to off-white, round, scored tablets, imprinted “KET” over bisect “200″ on one side, and “APO” on the other side; supplied in bottles of 30 tablets (NDC 60505-0092-2), bottles of 100 tablets (NDC 60505-0092-0) and bottles of 1000 tablets (NDC 60505-0092-1).

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .

Dispense in a tight, light-resistant container as defined in the USP.


APOTEX INC.
KETOCONAZOLE TABLETS USP
200 mg

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326

Revised: July 2004

Rev. 0

PRINCIPAL DISPLAY PANEL — 200mg

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-0092-2

Ketoconazole Tablet

200 mg

Rx

30 bottle count

Ketoconazoletablet30tablets
(click image for full-size original)
KETOCONAZOLE
ketoconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0092
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
METHYLCELLULOSE (15 CPS)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code KET;200;APO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0092-2 30 TABLET in 1 BOTTLE None
2 NDC:60505-0092-0 100 TABLET in 1 BOTTLE None
3 NDC:60505-0092-1 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075912 01/10/2002
Labeler — Apotex Corp (845263701)
Registrant — Apotex Inc (209429182)
Establishment
Name Address ID/FEI Operations
Apotex Inc 205576023 manufacture (60505-0092), analysis (60505-0092)

Revised: 10/2012 Apotex Corp

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