Label Changes for:
Sporanox (itraconazole) Oral Solution, 10 mg/mL
March 2009
Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
Summary View
Sections Modified
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Sections Modified
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Summary of Changes to Contraindications and Warnings
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BOXED WARNING
CONTRAINDICATIONS
- Congestive Heart Failure
- Drug Interactions
WARNINGS
- Cardiac Dysrhythmias
- Cardiac Disease
- Treatment of Severely Neutropenic Patients
PRECAUTIONS
- Hearing Loss
- Transient or permanent hearing loss has been reported .....
- Information for Patients
- Instruct patients that hearing loss can occur...
- Drug Interactions Table additions
- ...disopyramide..(including nisoldipine)..levacetylmethadol (levomethadyl), ergot alkaloids, halofantrine..budesonide,
dexamethasone, fluticasone..warfarin, cilostazol, eletriptan, fentanyl...
- Antiarrhythmics
- The class IA antiarrhythmic disopyramide has the potential to increase the QT interval...
- ...via inhibition of P glycoprotein.
- Calcium Channel Blockers
- ...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
- Other
- Levacetylmethadol (levomethadyl) is known to prolong the QT...
- Elevated concentrations of ergot alkaloids can cause ergotism...
- Halofantrine has the potential to prolong the QT interval...
- Sporanox may..."glucocorticosteroids such as budesonide, dexamethasone, fluticasone and"...
- Cilostazol and eletriptan are CYP3A4 metabolized...
- Fentanyl plasma concentrations could...
- Pregnancy:Teratogenic Effects, Pregnancy Category C
- During post-marketing experience, cases of congenital abnormalities have been reported.
- Geriatric Use (new section)
- Renal Impairment (new section)
- Hepatic Impairment (new section)
ADVERSE REACTIONS
- Postmarketing Experience
- Revised and table updated
- Transient or permanent hearing loss
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BOXED WARNING
- Drug Interactions
- Coadministration of "levacetylmethadol (levomethadyl)" addition
- ..sudden death have occurred in patients using "levacetylmethadol (levomethadyl)"...
CONTRAINDICATIONS
- Congestive Heart Failure (new section)
- Drug Interactions
- nisoldipine
- levacetylmethadol
(levomethadyl)
- Ergot alkaloids metabolized...
WARNINGS
- Cardiac Dysrhythmias
- levacetylmethadol (levomethadyl)
- Cardiac Disease
- Itraconazole has been shown to have a negative inotropic effect.
- Sporanox has been associated with reports of congestive heart failure. In post-marketing...
- Calcium channel blockers can have negative inotropic effects
- Treatment of Severely Neutropenic Patients (new section)
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