Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, DELAYED RELEASE
DOSAGE AND ADMINISTRATION: Adults and adolescents (≥ 12 years of age): One AERIUS D-12 Tablet twice a day regardless of mealtime. For oral use. Caution: Do not chew, break or crush the tablet. Swallow whole. The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared. The incremental efficacy of pseudoephedrine over desloratadine alone has not been studied beyond a duration of two weeks.
ORAL
Medical Information
INDICATIONS AND USAGE: AERIUS D-12 Tablets are indicated for the relief of the nasal and non-nasal symptoms of allergic rhinitis, including nasal congestion, in adults and children 12 years of age and older. AERIUS D-12 Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant activity of pseudoephedrine are desired.
CONTRAINDICATIONS: AERIUS D-12 Tablets are contraindicated in patients who are hypersensitive to the active substance, to any of its excipients, to adrenergic agents or to loratadine. As AERIUS D-12 contains pseudoephedrine, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. AERIUS D-12 is also contraindicated in patients with - narrow-angle glaucoma, - urinary retention, - severe hypertension, - severe coronary artery disease, - hyperthyroidism, - a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke. This is due to the alpha-mimetic activity of pseudoephedrine in combination with other vasoconstrictors such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline...).
R01BA52
pseudoephedrine, combinations
Manufacturer Information
ORGANON SINGAPORE PTE. LTD.
Patheon Inc., Whitby Operations
Active Ingredients
Documents
Package Inserts
Aerius D12 Tablet Package Insert.pdf
Approved: August 16, 2022