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 may be increased to 400 mg (two tablets) once daily.

Children

In small numbers of children 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 children under 2 years of age.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole tablet 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 6 months.

Minimum treatment for recalcitrant dermatophyte infections is 4 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 are available containing 200 mg of ketoconazole, USP.

The 200 mg tablet is a white to off-white round tablet debossed with M above the score and 261 below the score on one side of the tablet and blank on the other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0842-1 200 mg 30 Tablets in a Blister Pack white to off-white 0378-0261

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light and moisture.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

www.mylan.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

PRINCIPAL DISPLAY PANEL — 200 mg

NDC 53808-0842-1

Ketoconazole
Tablets, USP
200 mg

Rx only 30 TABLETS

Each tablet contains:
Ketoconazole, USP 200 mg

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from moisture.

Usual Dosage: See accompanying
prescribing information.

Ketoconazole Tablets 200 mg Bottle Labels Ketoconazole Tablets 200 mg Bottle Labels
KETOCONAZOLE
ketoconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0842(NDC:0378-0261)
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;261
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0842-1 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075597 01/01/2013
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0842)

Revised: 09/2013 State of Florida DOH Central Pharmacy

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