HSA Reclassified Drug | Exemptions For Supply of Ketotifen Syrup Without Prescription

Criteria

Eligible Active Ingredient: Ketotifen Syrup. As an oral liquid preparation not exceeding 1mg/5ml
With Effective From: 1-Jun-17
Indication Permitted: Indications: Symptomatic treatment of allergic rhinitis and chronic urticaria
Maximum Daily Dose: 2mg
Maximum Supply per Transaction: 120ml
Minimum Age of User: 3 years
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

Mechanism of Action of Ketotifen Syrup

Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators from mast cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils have also been demonstrated. Ketotifen also inhibits cAMP phosphodiesterase. Properties of ketotifen which may contribute to its antiallergic activity and its ability to affect the underlying pathology of asthma include inhibition of the development of airway hyper-reactivity associated with activation of platelets by PAF (Platelet Activating Factor), inhibition of PAF-induced accumulation of eosinophils and platelets in the airways, suppression of the priming of eosinophils by human recombinant cytokines and antagonism of bronchoconstriction due to leukotrienes. Ketotifen inhibits of the release of allergic mediators such as histamine, leukotrienes C4 and D4(SRS-A) and PAF.

Additional Information of Ketotifen Syrup

Pharmacology Class: Antihistamines For Systemic Use
Therapeutic Class: Antihistamines For Systemic Use
Chemical Class: Other Antihistamines For Systemic Use
Synonyms: Ketotifene | Ketotifeno | Ketotifenum

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 Ketotifen Syrup As an oral liquid preparation not exceeding 1mg/5ml

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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.