Hypnomidate 2 mg/ml Injection (etomidate)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Etomidate, Hypnomidate

Date published: 07/12/2011 15:51

Type of SPC Change: Revised SPC

Generic drug name: Etomidate

Drug brand name: Hypnomidate

Legal status: POM

Pharmaceutical manufacturer: Janssen-Cilag Ltd

Summary
by: Atisha Sharma

There have been significant updates to several sections of the SPC, including the following:

 

Change to section 4.4 - Special warnings and precautions for Use

Use with caution in patients with underlying cortico-adrenal insufficiency such as patients with sepsis. Prolonged suppression of endogenous cortisol and aldosterone may occur. Myoclonus and pain on injection, including venous pain, may occur so administer small dose of suitable opioids, e.g. fentanyl, 1 to 2 minutes before induction.  

 

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Hypnotic effect may be enhanced by neuroleptic drugs, opioids, sedatives and alcohol. Slight and transient reduction in peripheral resistance may enhance the effect of other drugs reducing blood pressure. Alfentanil has been reported to decrease the terminal half-life of etomidate. Co-administration with ketamine appears to have no significant effect.

 

Change to section 4.9 - Overdose

Overdosage may depress cortical secretion. Adequate respiratory support is mandatory.

 

Please refer to SPC link below for full information on all changes.

SPC

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