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HSA Reclassified Drug | Exemptions For Supply of Budesonide Without Prescription

 

Criteria

Eligible Active Ingredient: Budesonide. As a nasal spray
With Effective From: 19-Nov-2022
Indication Permitted: Prevention and treatment of allergic rhinitis
Maximum Daily Dose: 200 mcg/nostril
Maximum Supply per Transaction: 3 months
Minimum Age of User: 18 years
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

 

Mechanism of Action of Budesonide

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. The precise mechanism of corticosteroid actions on inflammation in asthma, Crohn’s disease, or ulcerative colitis is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in the aforementioned diseases. Because budesonide undergoes significant first-pass elimination, the both oral preparations are formulated as an extended release tablet. As a result, budesonide release is delayed until exposure to a pH < 7 in the small intestine.

Additional Information of Budesonide

Pharmacology Class: Other Drugs For Obstructive Airway Diseases, Inhalants
Therapeutic Class: Drugs For Obstructive Airway Diseases
Chemical Class: Glucocorticoids
Synonyms: (11beta,16alpha)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione

 

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 Budesonide As a nasal spray

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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.

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