Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Aerius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:
The recommended dose of Aerius is one tablet once a day.
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 the allergen exposure periods.
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
The safety and efficacy of Aerius 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available.
Oral use.
The dose can be taken with or without food.
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Shelf life: 2 years.
Do not store above 30°C.
Store in the original package.
Aerius is supplied in blisters comprised of laminate blister film with foil lidding.
The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product contact surface) with an aluminium foil lidding coated with a vinyl heat seal coat (product contact surface) which is heat sealed.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
