1 INDICATIONS AND USAGE Ketamine Hydrochloride Injection is indicated: • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.

• for the induction of anesthesia prior to the administration of other general anesthetic agents.

• as a supplement to other anesthetic agents.

Ketamine Hydrochloride Injection is a general anesthetic indicated: • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation ( 1 ) • for the induction of anesthesia prior to the administration of other general anesthetic agents ( 1 ) • as a supplement to other anesthetic agents.

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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 Ketamine Hydrochloride Injection 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 with or without evidence of biliary obstruction has been reported with recurrent use (e.g., misuse/abuse or medically supervised unapproved indications).

Administration site disorders : Local pain and exanthema at the injection site.

Immune system disorders : Anaphylaxis.

Neurologic disorders : Emergence reactions (post-operative delirium), [see Warnings and Precautions (5.2) ] .

During administration, enhanced muscle tone and spasms (resembling a partial motor or generalized motor seizure).

Psychiatric disorders : Adverse psychiatric events have occurred and/or persisted days to weeks after ketamine exposure.

Renal and urinary disorders : In individuals with history of chronic ketamine use or abuse, lower urinary tract and bladder symptoms including dysuria, increased urinary frequency, urgency, urge incontinence, and hematuria have been reported [see Dosage and Administration (2.1) ] .

In addition, diagnostic studies performed to assess the cause of these symptoms have reported cystitis (including cystitis non-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) as well as hydronephrosis and reduced bladder capacity.

Respiratory disorders : Respiratory depression and apnea following rapid intravenous administration of high doses of ketamine hydrochloride injection; laryngospasm, and airway obstruction.

Skin and subcutaneous tissue disorders : Transient erythema and/or morbilliform rash.

The most common adverse reactions are emergence reactions and elevated blood pressure and pulse.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.

at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.