Note: Barbiturates and Ketacil hydrochloride, being chemically incompatible because of precipitate formation, should not be injected from the same syringe.
If the Ketacil hydrochloride dose is augmented with diazepam, the two drugs must be given separately. Do not mix Ketacil hydrochloride 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.
Because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration.
The onset of action of Ketacil hydrochloride 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, 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 lasting 12 to 25 minutes.
As with other general anesthetic agents, the individual response to Ketacil hydrochloride 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.
The initial dose of Ketacil hydrochloride 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 Ketacil 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 less will 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 Ketacil hydrochloride 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.
It is recommended that Ketacil hydrochloride be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.
The initial dose of Ketacil hydrochloride 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.
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 Ketacil hydrochloride administered, the longer will be the time to complete recovery.
Adult patients induced with Ketacil hydrochloride augmented with intravenous diazepam may be maintained on Ketacil hydrochloride 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 maintenance dosage program.
To prepare a dilute solution containing 1 mg of Ketacil per mL, aseptically transfer 10 mL from a 50 mg per mL vial or 5 mL from a 100 mg per mL vial to 500 mL of 5% Dextrose Injection, USP or Sodium Chloride (0.9%) Injection, USP (Normal Saline) and mix well. The resultant solution will contain 1 mg of Ketacil per mL.
The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of Ketacil hydrochloride injection. If fluid restriction is required, Ketacil hydrochloride injection can be added to a 250 mL infusion as described above to provide a Ketacil hydrochloride concentration of 2 mg/mL. Ketacil hydrochloride injection 10 mg/mL vials are not recommended for dilution.
Ketacil hydrochloride is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.
The regimen of a reduced dose of Ketacil hydrochloride supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.
Ketacil hydrochloride injection is supplied as the hydrochloride in concentrations equivalent to Ketacil base.
NDC 42023-137-10 - Each 20-mL multi-dose vial contains 10 mg/mL. Supplied in cartons of 10.
NDC 42023-138-10 - Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10.
NDC 42023-139-10 - Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10.
Store between 20° to 25°C (68° to 77°F).
Protect from light.
Manufactured and Distributed by: JHP Pharmaceuticals, LLC, Rochester, MI 48307. Revised: Feb 2013
Tell your doctor about all other medicines you use, especially:
If you are using any of these drugs, it may take you longer to recover from anesthesia with Ketacil.
This list is not complete and other drugs may interact with Ketacil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketacil.
Ketacil is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
Ketacil may potentiate the neuromuscular-blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.
The use of halogenated anaesthetics concomitantly with Ketacil can lengthen the elimination half-life of Ketacil and delay recovery from anaesthesia. Concurrent use of Ketacil (especially in high doses or when rapidly administered) with halogenated anaesthetics can increase the risk of developing bradycardia, hypotension or decreased cardiac output.
The use of Ketacil with other CNS depressants (eg, ethanol, phenothiazines, sedating H1-blockers or skeletal muscle relaxants) can potentiate CNS depression and/or increase risk of developing respiratory depression. Reduced doses of Ketacil may be required with concurrent administration of other anxiolytics, sedatives and hypnotics.
Ketacil has been reported to antagonise the hypnotic effect of thiopental.
Patients taking thyroid hormones have an increased risk of developing hypertension and tachycardia when given Ketacil.
Concomitant use of antihypertensive agents and Ketacil increases the risk of developing hypotension.
When Ketacil and theophylline are given concurrently, a clinically significant reduction in the seizure threshold is observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.
Incompatibilities: Ketacil is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
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Information checked by Dr. Sachin Kumar, MD Pharmacology