HSA Reclassified Drug | Exemptions For Supply of Desloratadine and Pseudoephedrine Without Prescription

 

Criteria

Eligible Active Ingredient: Desloratadine and Pseudoephedrine. As a modified release oral solid dosage form containing desloratadine 2.5mg and pseudoephedrine 120mg
With Effective From: 1-Jan-2012
Indication Permitted: For the relief of symptoms associated with allergic rhinitis including nasal congestion, sneezing, runny nose, itching of the nose and/or eyes It should be administered when both the antihistaminic properties of desloratadine and the decongestant effect o
Maximum Daily Dose: 1 tablet twice daily. 2 tablets/day
Maximum Supply per Transaction: 10 tablets
Minimum Age of User: 12 years
Patient Information Leaflet from HSA/PSS: Download PIL (Link to HSA website)

 

Mechanism of Action of Desloratadine and Pseudoephedrine

Like other H1-blockers, Desloratadine competes with free histamine for binding at H<sub>1</sub>-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.

Pseudoephedrine acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors. Through direct action on alpha-adrenergic receptors in the mucosa of the respiratory tract, pseudoephedrine produces vasoconstriction. Pseudoephedrine relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors. Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Additional Information of Desloratadine and Pseudoephedrine

Pharmacology Class: Nasal Decongestants For Systemic Use
Therapeutic Class: Nasal Preparations
Chemical Class: Sympathomimetics
Synonyms: 8-Chloro-11-piperidin-4-ylidene-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine | 8-chloro-6,11-dihydro-11-(4-Piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine | Descarboethoxyloratadine | DESLORATADINE | (+) threo-2-(methylamino)-1-phenyl-1-propanol | (+)-(1S,2S)-Pseudoephedrine | (+)-Pseudoephedrine | (+)-psi-Ephedrine | (+)-threo-Ephedrine | d-Isoephedrine | d-Pseudoephedrine | d-psi-2-Methylamino-1-phenyl-1-propanol | d-psi-Ephedrine | Isoephedrine | L-(+)-Pseudoephedrine | L(+)-psi-Ephedrine | Pseudoefedrina | pseudo√©ph√©drine | Pseudoephedrine D-form | Pseudoephedrinum | Psi-ephedrin | Psi-ephedrine | trans-Ephedrine | œà-ephedrine

 

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 Desloratadine and Pseudoephedrine As a modified release oral solid dosage form containing desloratadine 2.5mg and pseudoephedrine 120mg

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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.