Label Changes for:
Demerol (meperidine hydrochloride)
Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April and October 2011
- Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur
- DEMEROL is contraindicated in patients with severe respiratory insufficiency
- …or renal function; and toxic psychosis (see PRECAUTIONS, Special Risk Patients)
Interactions with Other CNS Depressants
- Drug-drug interactions may result in respiratory depression, hypotension, profound sedation, coma or death if...
Interactions with Mixed Agonist/Antagonist Opioid Analgesics
- added...may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors
Tolerance and Physical Dependence
- added...Meperidine has the potential to produce tolerance and drug dependence
- CNS Depressants: Concomittant use of CNS depressants with usual doses of Demerol may result in....
- Phenytoin: ...were increased, thus caution should be exercised when...
- Reducing the total daily dose of meperidine is recommended in elderly patients...
- Nervous System: Mood changes (e.g. euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, confusion, delirium, visual disturbances
- ... Prolonged meperidine use may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.
- ... If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk to the patient.
- Pruritus ... anaphylaxis, shock.