HSA Reclassified Drug | Exemptions For Supply of Ambroxol Tablet Without Prescription

Criteria

Eligible Active Ingredient: Ambroxol Tablet. As an oral solid preparation containing not more than 30mg.
With Effective From: 1-Jul-2011
Indication Permitted: To clear the chest by thinning the mucus in air passages
Maximum Daily Dose: Criteria Not Specified
Maximum Supply per Transaction: Criteria Not Specified
Minimum Age of User: Criteria Not Specified
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

Mechanism of Action of Ambroxol Tablet

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Additional Information of Ambroxol Tablet

Pharmacology Class: Expectorants, excluding Combinations With Cough Suppressants
Therapeutic Class: Cough And Cold Preparations
Chemical Class: Mucolytics
Synonyms: Ambroxolum | Bisolvon metabolite vIII | Bromhexine metabolite vIII | Bromhexine-metabolite vIII | Cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (E)- | N-(2-Amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol | N-(2-Amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol | trans-4-((2-Amino-3,5-dibromobencil)amino)ciclohexanol | trans-4-((2-Amino-3,5-dibromobenzyl)amine)cyclohexanol | trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol

Show All HSA-registered therapeutic products granted exemption to supply without prescription

References

  1. Health Science Authority of Singapore – Reclassified POM
  2. Drugbank

HSA-Registered Products Containing Ambroxol Tablet As an oral solid preparation containing not more than 30mg.

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This list is not exhaustive. HSA collaborates with Pharmaceurical Society of Singapore (PSS) to review the appropriate use of therapeutic products in the community from time to time. Hence, HSA may enable the supply of a Prescription Only Medicine (POM) by pharmacists without a prescription, upon review that the product can be used in a safe and effective manner under the supervision of a pharmacist. This can be effected through legislative mechanisms in the absence of an application made by the product registrant to reclassify the therapeutic product, subject to to conditions including indication, strength, maximum daily dose, maximum supply quantity, and age restriction.