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ATC codes: A04AD01
EMLc
Indication
Palliative care ICD11 code: QC7A
Medicine type
Chemical agent
List type
Core
Formulations
Local > Topical > Transdermal patch: 1 mg per 72 hours transdermal patch (EMLc)
Parenteral > General injections > unspecified: 400 µg per mL injection (EMLc) ; 600 µg per mL injection (EMLc)
EML status history
First added in 2009 (TRS 958)
Sex
All
Age
Children (1 month - 12 years)
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
Hyoscine hydrobromide was added to the EMLc in 2009 for the management of excessive respiratory tract secretions in children receiving palliative care. The EMLc Subcommittee considered a review of medicines for palliative care commissioned by the Secretariat to ensure that appropriate medicines for the pharmacological management of the most prevalent and distressing symptoms in children with life-threatening and life-limiting conditions worldwide are included in the EMLc. The Subcommittee noted that malignancy and HIV/AIDS were identified as the most common causes of childhood mortality appropriate to palliative care worldwide and that the 10 most frequent symptoms and symptom clusters (fatigue and weakness, pain, anorexia and weight loss, delirium and agitation, breathlessness, nausea and vomiting, constipation, depression, excess respiratory tract secretions and anxiety) had been identified based on available data. The Subcommittee noted that the evidence to support efficacy and safety of medicines used in the management of these symptoms was generally weak and therefore, several recommendations in the proposal were based on experience from clinical practice. For the management of respiratory tract secretions, the proposal suggested that hyoscine hydrobromide may provide some benefit in terminal care. Despite the absence of data from large paediatric studies, the Subcommittee felt that the drug should be added to the EMLc. The Subcommittee particularly noted the potential usefulness of the patch presentation as an appropriate dosage form for use in children and decided, therefore to include the intravenous form and transdermal patch.