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NDC 67877-0454-30

Itraconazole 100 mg/1 CAPSULE, COATED PELLETS

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NDC
67877-0454-30
Generic Name
Itraconazole
Brand Name
Itraconazole
Strength
100 mg/1
Dosage Form
CAPSULE, COATED PELLETS
Route
ORAL
Package Size
—
Labeler
Ascend Laboratories, LLC

FDA Drug Information

Indications & Usage

INDICATIONS & USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other…

Important Warnings

WARNINGS Hepatic Effects: Itraconazole capsules has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, tre…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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