- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of levocetirizine
Allergic rhinitis - perennial and seasonal
5 mg once daily.
5 mg once daily.
Children 6 years and over
5 mg once daily.
The film-coated tablets are unsuitable for dose adaptation in children under 6 years.
Children 2 to 6 years
The daily recommended dose is 1.25 mg twice a day.
Patients with Renal Impairment
The dosage must be individualised according to renal function. An estimate of the patients creatinine clearance in ml/min is needed and the dose adjusted as indicated:
Creatinine clearance 80 ml/min or above
5 mg once daily.
Creatinine clearance 50 - 79 ml/min
5 mg once daily.
Creatinine clearance 30 - 49 ml/min
5 mg once every 2 days.
Creatinine clearance < 30 ml/min
5 mg once every 3 days.
In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There is no specific data for children with renal impairment.
Children under 2 years
Renal impairment - creatinine clearance below 10ml/minute
Precautions and Warnings
Children aged 2 to 6 years
Benign prostatic hyperplasia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of urinary retention
Renal impairment - creatinine clearance below 50ml/minute
Advise patient ability to drive or operate machinery may be impaired
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Tablet formulation not suitable for children under 6 years
May potentiate effect of CNS depressants
Pruritus may occur after treatment has stopped
Discontinue 3 days before allergy skin test
Advise patient to avoid excess of alcohol
Pregnancy and Lactation
Use levocetirizine with caution in pregnancy.
Limited information is available. Animal reproduction reports suggest low risk.
It is not known if levocetirizine crosses the human placenta. However, the molecular weight, approximately 390 for the free base, the minimum metabolism and the long plasma half-life suggest that the high plasma protein binding might lessen the amount crossing the placenta when the drug reaches the embryo-foetus.
The manufacturer notes that the use of levocetirizine during pregnancy may be considered.
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 levocetirizine with caution in breastfeeding.
Levocetirizine is a third-generation non-sedating antihistamine and is the active metabolite (L-enantiomer) of cetirizine. It has twice the binding affinity at the H1-receptor compared to cetirizine.
The molecular weight, approximately 390 for the free base, the minimum metabolism and the long plasma half-life suggest that the high plasma protein binding might lessen the amount excreted into breast milk.
The effects on a nursing infant are unknown but sedation or irritability are potential minor adverse effects.
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
Abnormal liver function
Disturbances in accommodation
Fixed drug eruption
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 2017.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 04 April 2017.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 04 April 2017.
Summary of Product Characteristics: Xyzal 5mg tablets. UCB Pharma Ltd. Revised March 2017.
Summary of Product Characteristics: Xyzal oral solution 0.5mg/ml. UCB Pharma Ltd. Revised March 2017.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.