INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HYPNOMIDATE® Injection.

© J-C 1997                Z-Afrika - 227692/V1 V

SCHEDULING STATUS:
Schedule 5.

PROPRIETARY NAME
(and dosage form):

HYPNOMIDATE® Injection.

COMPOSITION:
A solution of 2 mg/mL of
etomidate in propylene glycol and water.

PHARMACOLOGICAL CLASSIFICATION:
A 2.2 Central nervous system depressants. Sedatives, hypnotics.

PHARMACOLOGICAL ACTION:
HYPNOMIDATE is a short-acting intravenous anaesthetic agent unrelated to existing intravenous induction agents. It has no analgesic properties and therefore appropriate analgesic agents should be used concomitantly. In adults 0,3 mg/kg body weight (about 1 ampoule of 10 mL HYPNOMIDATE) induces hypnosis within 10 seconds, which lasts about five minutes (or generally longer in patients premedicated with sedatives). Hypnosis can be prolonged by additional injections of HYPNOMIDATE. Etomidate is rapidly hydrolysed, predominantly in the liver.
Pharmacokinetics:
Etomidate is predominantly metabolised in the liver. After 24 hours, 78% of the administered dose of etomidate has been eliminated through the urine. The plasma protein binding amounts to 76,5%. The volume of distribution is about 4,5 L/kg. The minimal plasma concentration introducing a hypnotic effect is about 0,3 micrograms/mL.

INDICATIONS:
HYPNOMIDATEis indicated for the induction of anaesthesia. It may be used as an anaesthetic for short painless procedures such as cardioversion, uterine curettage etc. Because HYPNOMIDATEhas no analgesic effect it is not suitable as a mono-anaesthetic.

CONTRA-INDICATIONS:
HYPNOMIDATE is contra-indicated in patients with known hypersensitivity to etomidate.
The safety of HYPNOMIDATE in human pregnancy has not been established.
During obstetric anaesthesia, etomidate may cross the placenta. A fall in cortisol levels lasting about 6 hours was observed in the neonate after the mother was given Hypnomidate. The decreased values remained within the normal range.
Safety in lactation has not been established.
Etomidate suppresses adrenocortical function and should not be used in patients with adrenocortical function that is already reduced or at risk of being reduced. In etomidate infusions suppress adrenocortical function and sudden death may occur.

DOSAGE AND DIRECTIONS FOR USE:
HYPNOMIDATEampoules contain a ready-for-use solution. 2 mg etomidate per mL solution.
HYPNOMIDATEis effective in doses ranging between 0,2 and 0,3 mg/kg (0,1 and 0,15 mL per kg) body mass. The medicine should be administered intravenously within 60 seconds.
Do not exceed the total amount of three ampoules (30 mL).
Dosage should be adjusted to the individual patient response and to clinical effects. In the elderly, a single dose of 0,15-0,2 mg/kg body weight should be given and the dose should be further adjusted according to effects.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
After administration of etomidate, the patient may experience nausea and/or vomiting or coughing, hiccough and/or shivering.
Respiratory depression and the possibility of apnoea necessitate the availability of resuscitation equipment.
Allergic reactions including cases of bronchospasm and anaphylactoid reactions have been reported. Cases reported from post-marketing surveillance with HYPNOMIDATE include laryngospasm, cardiac arrhythmias and convulsions.
Spontaneous movements of one or more muscle groups may occasionally occur, especially when no premedication has been administered. These movements are attributed to a disinhibition of subcortical centres and can largely be prevented by intravenous administration of small doses of fentanyl, Thalamonal or diazepam, 1-2 minutes before induction with HYPNOMIDATE.
Pain can occur after administration into the small veins of the dorsum of the hand. Use of larger veins reduces pain on injection. Venous irritation has occurred following HYPNOMIDATE.
Induction doses of etomidate have been associated with low plasma cortisol levels unresponsive to ACTH-injection. These have not been associated with changes in vital signs or evidence of increased mobidity.
Precautions:
HYPNOMIDATE should only be administered intravenously. When HYPNOMIDATE is used, resuscitation equipment should be readily available to manage apnoea.
In patients with liver cirrhosis, or in those who have already received neuroleptic, opiate or sedative agents, the dose of etomidate should be reduced.
Since HYPNOMIDATE has no analgesic action, appropriate analgesics should be used during surgical procedures.
Induction with HYPNOMIDATE may produce hypotension, caused by a decrease in peripheral vascular resistance (especially when fentanyl and droperidol or droperidol are used as premedication). In some weakened patients in whom hypotension could be a problem, the following measures should be taken:
1. Set up an infusion before the indication of anaesthesia, to facilitate subsequent volume replacement in the circulatory system.
2. Restrict, as much as possible, other compounds which may cause hypotension.
3. Perform the induction with the patient in a recumbent position.
4. Inject the medicine slowly (during 1 minute).
Interactions:
Sedative medicines potentiate the hypnotic effect of HYPNOMIDATE.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms
:
An overdose of etomidate, administered as a bolus, deepens sleep and may cause respiratory depression and even respiratory arrest, in which case adequate respiratory support is mandatory. Hypotension has also been observed in such cases. Overdosage by prolonged infusion may severely depress cortical secretion. This may be associated with disorientation and delayed awakening.
Treatment:
Supportive and symptomatic.

IDENTIFICATION:
A clear, colourless solution in a 10 mL glass ampoule.

PRESENTATION:
10 mL colourless glass ampoules containing 2 mg/mL HYPNOMIDATEin a ready to use solution, packed in boxes of 5 ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
M/2.2/183.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15th ROAD
HALFWAY HOUSE, 1685.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 May 1996

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Updated on this site: March 2004
Source: Pharmaceutical Industry

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