Label Changes for:
Sporanox (itraconazole) Injection, 10 mg/mL
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT 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 of Changes to Contraindications and Warnings
- Hearing Loss
- Transient or permanent hearing loss has been reported .....
- Information for Patients
- Instruct patients that hearing loss can occur...
- Concomitant administration of digoxin...added "via inhibition of P-glycoprotein"
- Drug Interactions/Calcium Channel Blockers
- added...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
- Drug Interactions/Other
- Fentanyl plasma concentrations could be increased or prolonged by concomitant use of Sporanox and may cause potentially fatal respiratory depression
- Geriatric Use
- Transient or permanent hearing loss has been reported...
- Renal Impairment (new)
- Hepatic Impairment (new)
- Post-marketing Experience (replaced with table)
- Adverse drug reactions that have been identified during post-approval use of Sporanox (all formulations) are listed ...
PATIENT PACKAGE INSERT
- Who Should Not Take Sporanox and What Are The Possible Side Effects Of Sporanox section
- Cardiac Disease
- Sporanox has been associated with reports of congestive heart failure. In post-marketing...
- Calcium channel blockers can have negative inotropic effects