HSA Reclassified Drug | Exemptions For Supply of Topical Betamethasone Without Prescription

 

Criteria

Eligible Active Ingredient: Topical Betamethasone. As a topical preparation (as valerate or dipropionate salt) as a single agent not exceeding 0.1%
With Effective From: 31-Mar-16
Indication Permitted: Symptomatic relief of inflammatory skin or scalp disorders such as dermatitis and eczema
Maximum Daily Dose: Apply to affected areas twice daily
Maximum Supply per Transaction: 15g for cream/ointment/gel; 30ml for topical solution
Minimum Age of User: 18 years
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

 

Mechanism of Action of Topical Betamethasone

Betamethasone is a glucocorticoid receptor agonist. This leads to changes in genetic expression once this complex binds to the GRE. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Betamethasone binds to plasma transcortin, and it becomes active when it is not bound to transcortin.

Additional Information of Topical Betamethasone

Pharmacology Class: Corticosteroids, Plain
Therapeutic Class: Corticosteroids, Dermatological Preparations
Chemical Class: Corticosteroids, Potent (Group III)
Synonyms: 16beta-Methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione | 16β-Methyl-1,4-pregnadiene-9α-fluoro-11β,17α,21-triol-3,20-dione | 9-Fluoro-16beta-methylprednisolone | 9-Fluoro-16β-methylprednisolone | 9alpha-Fluoro-16beta-methylprednisolone | 9α-Fluoro-16β-methylprednisolone | beta-Methasone alcohol | Betadexamethasone | Betametasona | Betamethasone | Betamethasonum | Betamethasonvalerat Mikron | Rinderon

 

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 Topical Betamethasone As a topical preparation (as valerate or dipropionate salt) as a single agent not exceeding 0.1%

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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.