Who can administer
Administration RESTRICTED - see Appendix 1
Important information
Flush lines with Glucose 5%
Available preparations
Tambocor 150mg in 15ml (10mg/ml) ampoule
Reconstitution
Already in solution
Draw up using a 5micron filter needle
Infusion fluids
Glucose 5% (preferred)
Sodium chloride 0.9% (less stable- see under further information)
Methods of intravenous administration
Intermittent intravenous infusion (using an electronically controlled infusion device)
- May be diluted to any convenient volume with infusion solution - suggest dilute (with glucose 5%) to a concentration of 1mg per ml
- Administer required dose over 10 to 30 minutes (see under dose for details)
- Whilst unlikely to be practical flecainide may be given undiluted as a slow intravenous injection over SAME DURATION as intermittent infusion above.
Continuous intravenous infusion(using an electronically controlled infusion device)
- May be diluted to any convenient volume with glucose 5%. Consider a concentration of 1mg per ml.
- See under Dose for suitable rate
Dose in adults
Emergency use or for rapid effect
- Administer 2mg/kg (to a maximum of 150mg) as a bolus injection or infusion over at least ten minutes (but see also next point)
- In patients with sustained tachycardia or those with a history of cardiac failure who may become decompensated during the administration, administer over 30 minutes
- Alternatively, may give as divided doses
- Stop the drug once there is control of the arrhythmia
Prolonged therapy required
- Once initial dose has been administered as above, give
- First hour: 1.5mg/kg/hour
- Second and later hours: 0.1 to 0.25mg/kg/hour until arrhythmia controlled
- It is recommended that the infusion duration should not exceed 24 hours. However, where this is considered necessary, or for patients receiving the upper end of the dose range, plasma level monitoring is strongly recommended (see under Further Information')
- Maximum cumulative dose in first 24 hours should not exceed 600mg
- Switch to oral therapy as soon as possible (give oral dose as soon as infusion stopped)
Renal impairment
- If CrCl less than 35ml/min/1.73m2, the maximum initial dose should be 100mg daily (or 50mg twice daily)
Hepatic impairment
- Use with caution in severe hepatic impairment
Monitoring
- Monitor ECG continuously when giving by intravenous injection, when infusing for longer than 24 hours and when using doses at the upper end of the dose range
- Therapeutic drug level monitoring is recommended for patients on high doses or extended periods, or for those with renal or hepatic impairment. However, as samples are sent to UK for processing, there may be a significant time delay in getting results - contact Biochemistry for further details
Further information
- Glucose 5% is the preferred infusion fluid
- However, if necessary, may use Sodium chloride 0.9% but the concentration cannot exceed 150mg in 500ml (0.3mg/ml) to avoid precipitation (ref 1)
- Plasma level monitoring is recommended where therapy extends beyond 24 hours, or in those with renal or hepatic impairment (see SPC for details on required levels)
Storage
- Store below 30 C
- Do not freeze
References
SPC October 2020
1: Injectable medicines guide, Medusa, downloaded 10/10/2022
Therapeutic classification
Anti-arrhythmic