Composition


Each dosage unit contains

10 ml Vial

2 ml Ampoule

Ketamine (as hydrochloride)

500 mg

100 mg

Benzethonium chloride

1 mg





Therapeutic Indications


Diagnostic/Surgical Procedures: It is the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
KETAM is best suited for short procedures, but it can be used with additional doses for longer procedures.

Anaesthesia: For induction of anaesthesia prior to administration of other general anaesthetics.

A Supplementary Anaesthetic: To supplement low-potency agents, such as nitrous oxide.



Dosage and Administration


Dosage should be individualized.

KETAM is administered by IV injection, IV infusion or by IM injection.

For induction, IV injection of a dose of 2 mg/kg given over 60 seconds usually produces surgical anaesthesia within 30 seconds and lasting for 5–10 minutes.
In addition, diazepam may be given in 2–5 mg doses (total < 15 mg IV) in a separate syringe over 60 seconds.
Administer slowly (over 60 seconds).
More rapid administration may result in respiratory depression.

For induction by IV infusion, a total dose of 0.5–2 mg/kg is usually given on an appropriate infusion rate.

IM injection of a dose of 10 mg/kg usually produces surgical anaesthesia within 3–4 minutes lasting for 12–25 minutes.
For diagnostic or other procedures not involving intense pain, an initial IM dose of 4 mg/kg has been used.

Maintenance dose is given as increments of one–half to the full induction dose, may be repeated as needed for maintenance of anaesthesia.
The larger the total dose administered, the longer the time to complete recovery.

Dilution: To prepare a dilute solution containing 1 mg/ml, transfer 10 ml (50 mg/ml vial) to 500 ml of 5% dextrose injection or 0.9% sodium chloride injection and mix well.
If fluid restriction is required, add KETAM vial to a 250 ml infusion, as described above, to provide a 2 mg/ml concentration.

Admixture incompatibility: Barbiturates or diazepam and KETAM should not be mixed in the same syringe or infusion flask.



Contraindications


Hypersensitivity to the product.

Patients in whom a significant elevation of blood pressure would be a serious hazard.

Increased intraocular pressure or eye injury.

Psychotic disorders.

Pregnancy.



Warnings and Precautions


Monitor cardiac function continuously during the procedure in patients with hypertension or cardiac decompensation.

Do not use in surgery or diagnostic procedures of the pharynx, larynx or bronchial tree.

Do not administer KETAM alone because pharyngeal and laryngeal reflexes are usually active.
Muscle relaxants, with proper attention to respiration, may be required.

Vomiting has been reported following administration.
Laryngeal-pharyngeal reflexes may offer some airway protection, however the possibility of aspiration must be considered because protective reflexes may also be diminished by supplementary anaesthetics and muscle relaxants.

Give atropine, scopolamine or another drying agent at an appropriate interval prior to induction.

KETAM should be used with caution in patients with elevated CSF pressure.

Use with caution in chronic alcoholics and acutely alcohol intoxicated patients.

Resuscitative equipment should be ready for use.

Verbal, tactile, and visual stimuli should be kept to a minimum in an attempt to reduce the risk of emergence reactions.

Patients should be warned not to drive or operate machinery or engage in hazardous activities for 24 hours or more after anaesthesia.

Treatment of overdosage: Respiratory depression may occur with overdosage or too rapid a rate of administration, in which case employ supportive ventilation.
Mechanical support of respiration is preferred to administration of analeptics.



Drug Interactions


Inhalation anaesthetics, such as ether and halothane, and other cerebral depressants may prolong the effect of KETAM and delay recovery.

Prolonged recovery has also occurred when barbiturates and/or narcotics have been given concomitantly with KETAM.

KETAM should not be used with ergometrine.

Concurrent use with thyroid hormones may produce hypertension and tachycardia.

Theophyllines may produce seizures and tachycardia when coadministered with KETAM.



Effects on ability to drive and to use machines


Patients should be warned not to drive or operate machinery or engage in hazardous activities for 24 hours or more after anaesthesia.



Undesirable Effects


Emergence reactions are common during recovery from KETAM anaesthesia and include unpleasant dreams, confusion, hallucinations and irrational behaviour.

Other side effects may include increased muscle tone, sometimes resembling seizures; blood pressure and heart rate may be temporarily increased; hypotension, arrhythmias, bradycardia, anorexia, nausea, vomiting, and hypersalivation.
Respiration may be depressed following rapid IV injection or with high doses.
Apnoea, laryngospasm, diplopia, nystagmus, lacrimation, and raised intra-ocular and CSF pressure have also been reported.
Transient skin rashes and pain at the site of injection may occur.



Overdose


Treatment of Overdose:

Respiratory depression may occur with overdosage or too rapid a rate of administration, in which case employ supportive ventilation.
Mechanical support of respiration is preferred to administration of analeptics.



Pharmacological Properties


KETAM (ketamine) is a rapid-acting general anaesthetic agent.
It produces dissociative anaesthesia characterized by a trance-like state, amnesia, and marked analgesia which may persist into the recovery period.
The anaesthetic state is also characterized by normal pharyngeal-laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and the patient's eyes may remain open for all or part of the period of anaesthesia.


KETAM is considered to be of particular value in children requiring frequent repeated anaesthesia.


Recovery is relatively slow.

Pharmacokinetic:

Following IV administration, the ketamine concentration has an initial slope (alpha phase) lasting about 45 minutes with a half-life of 10 to 15 minutes.
This first phase, which represents ketamine's anaesthetic action, is terminated by redistribution from the CNS to peripheral tissues and hepatic biotransformation to an active metabolite norketamine.
The beta phase half-life of ketamine is about
2.5 hours.
Ketamine is excreted mainly in the urine as metabolites.
It crosses the placenta.



Packaging



KETAM Vials: Vials of 10 ml each.

KETAM Ampoules: Ampoules of 2 ml each.