"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...
Ketamine hydrochloride (ketamine hcl) injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride (ketamine hcl) injection is best suited for short procedures but it can be used, with additional doses, for longer procedures.
Ketamine hydrochloride (ketamine hcl) injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.
Ketamine hydrochloride (ketamine hcl) injection is indicated to supplement low-potency agents, such as nitrous oxide.
Specific areas of application are described in the CLINICAL PHARMACOLOGY section.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Note: Barbiturates and ketamine, being chemically incompatible because of precipitate formation, should notbe injected from the same syringe.
If the ketamine dose is augmented with diazepam, the two drugs must be given separately. Do not mix ketamine hydrochloride (ketamine hcl) and diazepam in syringe or infusion flask. For additional information on the use of diazepam, refer to the WARNINGS and DOSAGE AND ADMINISTRATION sections of the diazepam insert.
- While vomiting has been reported following ketamine administration, some airway protection may be afforded because of active laryngeal-pharyngeal reflexes. However, since aspiration may occur with ketamine and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration must be considered. Ketamine is recommended for use in the patient whose stomach is not empty when, in the judgement of the practitioner, the benefits of the drug outweigh the possible risks.
- Atropine, scopolamine, or another drying agent should be given at an appropriate interval prior to induction.
Onset and Duration
Because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration.
The onset of action of ketamine is rapid; an intravenous dose of 2 mg/kg (1 mg/lb) of body weight usually produces surgical anesthesia within 30 seconds after injection, with the anesthetic effect usually lasting five to ten minutes. If a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia without producing significant cumulative effects.
Intramuscular doses, from experience primarily in children, in a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually last- ing 12 to 25 minutes.
As with other general anesthetic agents, the individual response to ketamine is somewhat varied depending on the dose, route of administration, and age of patient, so that dosage recommendation cannot be absolutely fixed. The drug should be titrated against the patient's requirements.
Intravenous Route: The initial dose of ketamine administered intravenously may range from 1 mg/kg to 4.5 mg/kg (0.5 to 2 mg/lb). The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg (1 mg/lb).
Alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous ketamine at a rate of 0.5 mg/kg/min may be used for induction of anesthesia. In addition, diazepam in 2 mg to 5 mg doses, administered in a separate syringe over 60 seconds, may be used. In most cases, 15 mg of intravenous diazepam or lesswill suffice. The incidence of psychological manifestations during emergence, particularly dream- like observations and emergence delirium, may be reduced by this induction dosage program.
Note: The 100 mg/mL concentration of ketamine should not be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.
Rate of Administration: It is recommended that ketamine be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.
Intramuscular Route: The initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg (3 to 6 mg/lb). A dose of 10 mg/kg (5 mg/lb) will usually produce 12 to 25 minutes of surgical anesthesia.
Maintenance of Anesthesia
The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic agent is employed.
Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic.
It should be recognized that the larger the total dose of ketamine administered, the longer will be the time to complete recovery.
Adult patients induced with ketamine augmented with intravenous diazepam may be maintained on ketamine given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute, augmented with diazepam 2 to 5 mg administered intravenously as needed. In many cases 20 mg or less of intravenous diazepam total for combined induction and maintenance will suffice. However, slightly more diazepam may be required depending on the nature and duration of the operation, physical status of the patient, and other factors. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this mainte- nance dosage program.
Dilution: To prepare a dilute solution containing 1 mg of ketamine per mL, aseptically transfer 10 mL (50 mg per mL vial) to 500 mL of Dextrose Injection, 5% or Sodium Chloride Injection, 0.9% and mix well. The resultant solution will contain 1 mg of ketamine per mL.
The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine hydrochloride (ketamine hcl) injection. If fluid restriction is required, ketamine hydrochloride (ketamine hcl) injection can be added to a 250 mL infusion as described above to provide a ketamine concentration of 2 mg/mL.
Ketamine is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.
Ketamine Hydrochloride (ketamine hcl) Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base.
NDC # 55390-475-10 Each 10 mL vial contains 50 mg/mL - supplied in a carton of 10.
Color of solution may vary from colorless to very slightly yellowish and may darken upon prolonged exposure to light. This darkening does not affect potency. Do not use if a precipitate appears. Protect from light.
Store at controlled room temperature, 15° to 30°C (59° to 86°F).
Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146. Manufactured for: Bedford Laboratories™ Bedford, OH 44146. June 2005. FDA Rev date: 4/3/2001
Last reviewed on RxList: 5/23/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Ketamine Hydrochloride Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.