KETALAR (ketamine hydrochloride) 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, and to supplement low-potency agents, such as nitrous oxide.
The initial dose of KETALAR administered intravenously may range from 1 mg/kg to 4.5 mg/kg. The average amount required to produce 5 to 10 minutes of surgical anesthesia within 30 seconds following injection is 2 mg/kg. Administer KETALAR slowly (i.e., over a period of 60 seconds). Do not intravenously inject the 100 mg/mL concentration of KETALAR without proper dilution. Dilute KETALAR with an equal volume of either Sterile Water for injection, USP, 0.9% Sodium Chloride Injection, USP (Normal Saline), or 5% Dextrose in Water. Use immediately after dilution.
The initial dose of KETALAR administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 9 to 13 mg/kg usually produces surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.
KETALAR injection is a clear, colorless, sterile solution available in multiple-dose vials containing either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride). It can come in the following: 200 mg/20 mL (10 mg/mL), 500 mg/10 mL (50 mg/mL), 500 mg/5 mL (100 mg/mL).
Warnings and precautions for KETALAR include: hemodynamic instability, emergence delirium reactions, respiratory depression, drug-induced liver injury, increase in cerebrospinal fluid pressure. Avoid KETALAR administration as a sole anesthetic agent during procedures of the pharynx, larynx, or bronchial tree, including mechanical stimulation of the pharynx.
Concomitant administration of KETALAR and theophylline or aminophylline may lower the seizure threshold. Sympathomimetics and vasopressin may enhance the sympathomimetic effects of ketamine. Concomitant use of ketamine with opioid analgesics, benzodiazepines, or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
KETALAR contains ketamine, a Schedule III controlled substance under the Controlled Substance Act. Thus, abuse and dependence may be possible.
KETALAR injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.