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Levocetirizine oral

Updated 2 Feb 2023 | Non-sedating antihistamines


Oral formulations of levocetirizine

Drugs List

  • levocetirizine 500microgram/ml oral solution sugar-free
  • levocetirizine 5mg tablets
  • XYZAL 500microgram/ml oral solution
  • XYZAL 5mg tablets
  • Therapeutic Indications


    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
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    History of urinary retention
    Lactose intolerance
    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 ( ) or if this is unavailable at the backup site ( ).


    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

    Side Effects

    Abdominal pain
    Abnormal liver function
    Anaphylactic shock
    Angioneurotic oedema
    Blurred vision
    CNS excitation
    Disturbances in accommodation
    Dry mouth
    Extrapyramidal effects
    Fixed drug eruption
    Gastro-intestinal discomfort
    Hypersensitivity reactions
    Movement disturbances
    Sleep disturbances
    Visual disturbances
    Weight gain


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2017.

    Reference Sources

    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.

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