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ATC codes: C01CA02
Indication
Bradycardia ICD11 code: MC81.1
INN
Isoprenaline
Medicine type
Chemical agent
List type
Complementary
Formulations
Parenteral > General injections > IV: 20 µg per mL in ampoule (hydrochloride)
EML status history
First added in 1993 (TRS 850)
Changed in 1997 (TRS 882)
Removed in 2005 (TRS 933)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
During its meeting in 2003, the Committee recommended that isoprenaline be reviewed for possible fast-track deletion at the meeting in 2005. The Committee noted that there was no published evidence to support the efficacy of isoprenaline in the emergency treatment of bradycardia. This was supported by the ISDB review which also concluded that cardiac pacing and other drug therapies provide effective, safer alternatives. The Japan Institute of Pharmacovigilance proposed that isoprenaline be retained because it is needed in the treatment of transient and reversible severe bradycardia where cardiac pacing is unavailable, and in the treatment of beta-blocker overdose. Unfortunately, no data were submitted to support these assertions, and the Committee could not find good clinical studies to support its efficacy and safety. The Committee therefore recommended that isoprenaline be deleted from the Model List because of the lack of evidence and the very limited indications for its use.