In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.
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.
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.
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.
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
PRINCIPAL DISPLAY PANEL — 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
Protect from moisture.
Usual Dosage: See accompanying
| KETOCONAZOLE |
|Labeler — State of Florida DOH Central Pharmacy (829348114)|
|State of Florida DOH Central Pharmacy||829348114||repack (53808-0842)|
Revised: 09/2013 State of Florida DOH Central Pharmacy
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