KETAMINE HYDROCHLORIDE INJECTION USP [SIN05966P]

Product Info

KETAMINE HYDROCHLORIDE INJECTION USP

[SIN05966P]

Indications: KETAMINE HYDROCHLORIDE INJECTION USP is recommended:

1. As the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. KETAMINE HYDROCHLORIDE INJECTION USP is best suited for short procedures but it can be used with additional doses, for longer procedures;

2. For the induction of anaesthesia prior to administration of other general anaesthetic agents;

3. To supplement low potency agents, such as nitrous oxide;

4. In obstetrics, for vaginal delivery or in caesarian section. Maternal side effects of awareness and dreaming can be reduced by the injection of diazepam or related drugs after the birth of the infant.

Dosage and Administration:
Dosage: As with other general anaesthetic drugs, the individual response to KETAMINE HYDROCHLORIDE INJECTION USP is somewhat varied depending on the dose, route of administration and age of patient, so that the dosage recommended cannot be absolutely fixed. The drug should be titrated against the patient’s requirements.
Onset and duration: Because of rapid induction following the initial intravenous injections, the patient should be in a supported position during administration. The onset of action of KETAMINE HYDROCHLORIDE INJECTION USP is rapid and intravenous dose of 2 mg/kg body weight usually produces surgical anaesthesia within 30 seconds after injection, with the anaesthetic effect usually lasting 5 to 10 minutes. lf a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anaesthesia without producing significant cumulative effect. lntramuscular doses from experience (primarily in children, in a range of 9 to 13 mg/kg) usually produce anaesthesia within 3 to 4 minutes following administration, with the anaesthetic effect usually lasting 12 to 25 minutes.
lnduction: lntravenous route: The initial dose of KETAMINE HYDROCHLORIDE INJECTION USP 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 anaesthesia has been 2 mg/kg.
Rate of administration: lt is recommended that KETAMINE HYDROCHLORIDE INJECTION USP is 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 HYDROCHLORIDE INJECTION USP administered intramuscularly ranges from 6.5 to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anaesthesia.
Maintenance of anaesthesia: Increments of one half to the full induction dose may be repeated, as needed, for maintenance of anaesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anaesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anaesthetic. lt should be recognized that the larger the total dose of KETAMINE HYDROCHLORIDE INJECTION USP administered, the longer will be the time to complete recovery.

Supplementary agents: KETAMINE HYDROCHLORIDE INJECTION USP is clinically compatible with commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained.

Contraindications

KETAMINE HYDROCHLORIDE INJECTION USP must not be administered in the following cases:

• Hypersensitivity to ketamine or to any of the excipients outlined in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Poorly controlled or untreated high blood pressure (arterial hypertension – systolic/diastolic blood pressure >180/100 mmHg at rest).

• Preeclampsia and eclampsia.

• Untreated or insufficiently treated hyperthyroidism.

• Situations where relaxed uterus muscles are required, e.g. impending rupture of the uterus, umbilical cord prolapse.