Label Changes for:
Clozaril (clozapine) Tablets
October 2011
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008 and October 2011
October 2011
WARNINGS
QT Interval Prolongation
- section added
PRECAUTIONS
Drug Interactions and Pharmacodynamic-Related Interactions
- ... QT prolongation
Pharmacokinetic-Related Interactions
- ... QT prolongation
DRUG INTERACTIONS
Post-marketing Clinical Experience
Cardiovascular system
- ... QT prolongation
| 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. Read about the new physician labeling format. |
November 2008
Sections Modified
PRECAUTIONS
- Drug Interactions
- Pharmacokinetic-Related Interactions
- Concomitant administration of drugs known to inhibit the activity of cytochrome P450 isozymes may increase the plasma levels of clozapine...
- citalopram (added to list of drugs)
- Concomitant administration of drugs known to inhibit the activity of cytochrome P450 isozymes may increase the plasma levels of clozapine...
- Pharmacokinetic-Related Interactions
ADVERSE REACTIONS
- Other Events Observed During the
Premarketing Evaluation of Clozaril (clozapine)- Metabolic and Nutritional Disorders (new subsection)
- hypercholesterolemia and hypertriglyceridemia
- Metabolic and Nutritional Disorders (new subsection)
For current prescribing information, contact Novartis Pharmaceuticals at 1-888-669-6682.
