Cetirizine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of cetirizine hydrochloride.
Drugs List
Therapeutic Indications
Uses
Chronic idiopathic urticaria
Rhinitis - perennial
Seasonal allergic rhinitis - treatment
Dosage
Adults
10mg once daily.
Children
Children aged 12 to 18 years: 10mg once daily.
Children aged 6 to 12 years: 5mg twice daily.
Children aged 2 to 6 years: 2.5mg twice daily.
Children aged 1 to 2 years (unlicensed): 250micrograms/kg twice daily.
Patients with Renal Impairment
There is no data related to the efficacy and safety in patients with renal impairment.
Since cetirizine is mainly excreted via the renal route, in cases no alternative treatment is available, the dose should be adjusted as follows:
Creatinine Clearance higher than or equal to 80 ml/min: 10 mg once a day
Creatinine Clearance equal to 50 to 79 ml/min: 10 mg once a day
Creatinine Clearance equal to 30 to 49 ml/min: 5 mg once a day
Creatinine Clearance less than 30 ml/min: 5 mg once every 2 days
Creatinine Clearance less than 10 ml/min: Contraindicated
Patients with Hepatic Impairment
No dose adjustment is needed in patients with solely hepatic impairment, however caution should be exercised and dose adjustment is recommended in patients with hepatic and renal impairment (see Patients with moderate to severe renal impairment table above).
Contraindications
Children under 1 year
Renal impairment - creatinine clearance below 10ml/minute
Precautions and Warnings
Children aged 1 to 2 years
Benign prostatic hyperplasia
Breastfeeding
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of urinary retention
Lactose intolerance
Pregnancy
Renal impairment - creatinine clearance 10-50ml/minute
Spinal cord compression
Not all available brands are licensed for all age groups
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Advise patient pruritus and/or urticaria may occur after discontinuation
May potentiate effect of CNS depressants
Discontinue 3 days before allergy skin test
Advise patient to avoid excess of alcohol
Advise patient of need for high oral hygiene standards
Pregnancy and Lactation
Pregnancy
Use cetirizine with caution during pregnancy.
One manufacturer notes that available data does not suggest maternal, foetal or embryonic toxicity above normal rates.
It is not known if cetirizine crosses the human placenta to the foetus. The molecular weight (about 462 for the dihydrochloride salt) is low enough, however, that transfer to the foetus should be expected.
No adverse effects have been reported in animal studies and there is no evidence in human pregnancy that it presents a significant risk to the foetus.
Lactation
Use cetirizine with caution during breastfeeding.
One manufacturer notes that cetirizine passes into breast milk and a risk of side effects in the breastfed infant cannot be excluded.
No published reports describing the use of cetirizine during human lactation have been located, but the manufacturers state that the antihistamine is excreted into human milk at concentrations representing 0.25 to 0.90 those measured in plasma. This would be consistent with the relatively low molecular weight (about 462 for the dihydrochloride salt). The effects, if any, on a nursing infant exposed to cetirizine in milk are unknown, but sedation is a possibility.
Cetirizine or loratadine preferred if non-sedating drug required. However consider whether the mother's hay fever is sufficiently severe to warrant treatment.
Side Effects
Abdominal pain
Abnormal liver function
Acute generalised exanthematous pustulosis
Aggression
Agitation
Alopecia
Amnesia
Anaphylactic shock
Angioedema
Anorexia
Arrhythmias
Arthralgia
Asthenia
Blood disorders
Blurred vision
Bronchospasm
CNS excitation
Confusion
Constipation
Convulsions
Cutaneous reactions
Depression
Diarrhoea
Difficulty in micturition
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyskinesia
Dystonia
Dysuria
Enuresis
Extrapyramidal effects
Fatigue
Fixed drug eruption
Gastro-intestinal discomfort
Glaucoma (closed angle)
Haemolytic anaemia
Hallucinations
Headache
Hypersensitivity reactions
Hypotension
Increased appetite
Increases in hepatic enzymes
Insomnia
Malaise
Memory disturbances
Movement disturbances
Nausea
Nightmares
Oculogyration
Oedema
Palpitations
Paraesthesia
Pharyngitis
Photosensitivity
Pruritus
Rash
Rhinitis
Serum bilirubin increased
Sleep disturbances
Somnolence
Suicidal tendencies
Syncope
Tachycardia
Thrombocytopenia
Tics
Tremor
Urinary retention
Urticaria
Vertigo
Vomiting
Weight gain
Overdosage
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 ).
Further Information
Last Full Review Date: April 2014.
Reference Sources
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Allacan 10mg tablets. Bristol Laboratories Ltd. Revised July 2014.
Summary of Product Characteristics: BecoAllergy 10mg Tablets. Omega Pharma Ltd. Revised February 2014.
Summary of Product Characteristics: Benadryl One a Day Relief tablets 10mg. McNeil Products Ltd. Revised September 2011.
Summary of Product Characteristics: Benadryl Allergy Oral Solution/Benadryl Allergy Children's 1mg/ml oral solution. McNeil Products Ltd. Revised May 2010.
Summary of Product Characteristics: Benadryl Allergy Children's 6+ 1mg/ml Oral Solution. McNeil Products Ltd. Revised May 2010.
Summary of Product Characteristics: Benadryl Allergy Liquid Release 10mg Capsules. McNeil Products Ltd. Revised September 2012.
Summary of Product Characteristics: Care Hayfever and Allergy 1mg/ml solution. Thornton & Ross Ltd. Revised February 2013
Summary of Product Characteristics: Hay Fever and Allergy Relief tablets 10mg. Herbal Concepts Ltd. Revised May 2005.
Summary of Product Characteristics: Piriteze Allergy tablets. GlaxoSmithKline Consumer Healthcare. Revised August 2012.
Summary of Product Characteristics: Piriteze Allergy Syrup. GlaxoSmithKline Consumer. Revised December 2017.
Summary of Product Characteristics: Pollenshield Hayfever Relief tablets 10mg. Actavis UK. Revised April 2011.
Summary of Product Characteristics: Ziralton Allergy Relief for Children 5mg/5ml Oral Solution. Pinewood Laboratories Limited. Revised September 2016.
Summary of Product Characteristics: Zirtek Allergy Relief tablets 10mg. UCB Pharma Ltd. Revised March 2019.
Summary of Product Characteristics: Zirtek Allergy tablets 10mg. UCB Pharma Ltd. Revised May 2019.
Summary of Product Characteristics: Zirtek Allergy Relief for Children. UCB Pharma Ltd, Revised March 2019.
Summary of Product Characteristics: Zirtek Allergy Solution 1mg/ml. UCB Pharma Ltd. Revised May 2019.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 07 June 2017
UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: April 10, 2014
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
Cetirizine hydrochloride; Last revised: September 7, 2013
Last accessed: April 10, 2014
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