Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemodynamic Instability [see Warnings and Precautions ( 5.1 )] Emergence Reactions [see Warnings and Precautions ( 5.2 )] Respiratory Depression [see Warnings and Precautions ( 5.3 )] Pediatric Neurotoxicity [see Warnings and Precautions ( 5.5 )] Drug-Induced Liver Injury [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of KETALAR were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular disorders : Elevated blood pressure, heart rate, and cardiac index;
decreases in blood pressure and heart rate;
arrhythmias;
cardiac decompensation (in patients with suspected catecholamine depletion).
Eye disorders : Diplopia, nystagmus, elevation in intraocular pressure.
Gastrointestinal disorders : Anorexia, nausea, vomiting;
hepatobiliary dysfunction, biliary duct dilatation, biliary duct stricture and/or stenosis with or without evidence of biliary obstruction;
secondary sclerosing cholangitis [see Warnings and Precautions ( 5.6 )].
5 WARNINGS AND PRECAUTIONS Hemodynamic Instability: Monitor vital signs and cardiac function during KETALAR administration.
( 5.1 ) Emergence Reactions: Postoperative confusional states may occur during the recovery period.
Reduce by minimizing verbal, tactile, and visual stimulation of the patient.
( 5.2 ) Risk of Respiratory Depression: May occur with overdosage or too rapid a rate of administration.
Maintain adequate oxygenation and ventilation.
Like all medications, Ketalar can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: