MedPath
HSA Approval

AERIUS ORAL SOLUTION 0.5 mg/ml

SIN12530P

AERIUS ORAL SOLUTION 0.5 mg/ml

AERIUS ORAL SOLUTION 0.5 mg/ml

April 5, 2004

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Regulatory Information

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

SOLUTION

DOSAGE AND ADMINISTRATION: The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin and there are no data supporting the treatment of infectious rhinitis with AERIUS®. Children 6 through 11 years of age: 5 ml (2.5 mg) AERIUS® Syrup and Oral Solution once a day, with or without a meal. Children 2 through 5 years of age: 2.5 ml (1.25 mg) AERIUS® Syrup and Oral Solution once a day, with or without a meal. Children 1 through 2 years of age (urticaria): 2.5 ml (1.25 mg) AERIUS® Syrup and Oral Solution once a day, with or without a meal. In adults and adolescents (12 years of age and over): 10 ml (5 mg) AERIUS® Syrup and Oral Solution once a day, with or without a meal. Desloratadine is not recommended for long-term use. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods.

ORAL

Medical Information

INDICATIONS AND USAGE: AERIUS® Syrup and Oral Solution are indicated for the rapid relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis), such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. AERIUS® Syrup and Oral Solution are also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives.

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients.

R06AX27

desloratadine

Manufacturer Information

ORGANON SINGAPORE PTE. LTD.

Organon Heist bv

Active Ingredients

Desloratadine, micronized

0.5 mg/mL

Desloratadine

Documents

Package Inserts

Aerius Syrup & Oral Solution PI.pdf

Approved: August 16, 2022

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