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 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 ( 1 ).

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 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; 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 Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.