Finished product reference
Clobutinol Hydrochloride
Solution, Drops · Oral · 60 mg/1mL · 15 mL
- List code
- 316
- Pharmacologic class
- Centrally acting antitussive (non-opioid)
What it is and how it works
Clobutinol suppresses the cough reflex by a direct action on the cough centre in the medulla, without opioid activity. It also blocks cardiac hERG potassium channels, which underlies its QT-prolonging effect.
Indications
Formerly used for symptomatic treatment of dry, non-productive cough; marketing authorisations were withdrawn in the European Union and many other countries in 2007 because of the risk of QT prolongation and arrhythmias.
Contraindications
Congenital or acquired QT prolongation; concomitant QT-prolonging drugs; hypokalaemia or hypomagnesaemia; significant bradycardia or heart failure; epilepsy; productive cough; hypersensitivity.
Warnings and precautions
Prolongs the QT interval and may cause ventricular arrhythmias, including torsade de pointes; it is no longer considered to have a favourable benefit–risk balance and safer alternatives should be used. Convulsions have been reported, particularly at high doses. Suppressing a productive cough can cause retention of secretions.
Pregnancy
Should not be used in pregnancy.
Storage and supply
Store below 25 °C, protected from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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