- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of desloratadine.
Rhinitis - allergic
5mg once daily.
The oral solution is licensed for use in children. The safety and efficacy of desloratadine tablets has not been established in children under 12 years of age.
Children aged 6 to 12 years: 2.5mg once daily.
Children aged 1 to 6 years: 1.25mg once daily.
Children aged over 12 years: 5mg once daily.
Patients with Renal Impairment
The Renal Drug Handbook notes a full dose may result in increased sedation in patients with glomerular filtration rate less than 10ml/min.
Children under 1 year
Precautions and Warnings
Children aged 1 to 12 years
Family history of epilepsy
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of seizures
Renal impairment - glomerular filtration rate below 10ml/minute
Advise ability to drive/operate machinery may be affected by side effects
Not all formulations are suitable for use in children under 12 years
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Discontinue treatment if patient develops seizures
May increase risk of seizure
Advise patient to avoid alcohol during treatment
Pregnancy and Lactation
Use desloratadine with caution in pregnancy.
The manufacturer notes a large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicates no malformative nor foeto/neonatal toxicity of desloratadine but as a precautionary measure, it is preferable to avoid the use of this medication during pregnancy.
Briggs, Freeman & Yaffe note that the animal reproduction data suggests low risk, but the absence of human pregnancy experience prevents a full assessment of the risk. Although there are no reports describing the use of desloratadine in human pregnancy, there are reports for loratadine, the parent compound, which demonstrate that it is not a major human teratogen.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use desloratadine with caution in breastfeeding.
The manufacturer notes that desloratadine has been identified in breastfed newborns/infants of treated women and notes a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Because of its expected low milk levels and lack of sedation and anticholinergic effects, maternal use of desloratadine is unlikely to affect a breastfed infant or milk production.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Elevation of liver enzymes
Prolongation of QT interval
Serum bilirubin increased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2015
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Neoclarityn 5mg film-coated tablets. Merck Sharp & Dohme Limited. Revised January 2020.
Summary of Product Characteristics: Neoclarityn Oral Solution. Merck Sharp & Dohme Limited. Revised January 2020.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NICE - Evidence Services Available at: www.nice.org.uk Last accessed: 23 June 2017.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Desloratadine Last revised: 10 March 2015
Last accessed: 21 April 2015.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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