Hydroxyzine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing hydroxyzine.
Drugs List
Therapeutic Indications
Uses
Anxiety state
Pruritus
Dosage
Prescribe the lowest effective dose for as short a time as possible.
Adults
Anxiety
50mg to 100mg daily in divided doses.
Pruritus
Initial dose: 25mg at night. The dose may be increased as necessary to 25mg three or four times a day (maximum daily dose 100mg).
Elderly
see Dosage; Adult
A reduced dose is advised. Maximum daily dose 50mg.
Children
Pruritus
Children 6 to 18 years (body weight 40kg and above)
Initially 15mg to 25mg daily, increased if necessary to a 50mg to 100mg in divided doses according to the child's weight.
Maximum daily dose 100mg.
Children 6 to 18 years (body weight under 40Kg)
Initially 15mg to 25mg daily, increased if necessary to a 50mg to 100mg in divided doses according to the child's weight.
Maximum daily dose 2mg/kg.
Children 6 months to 6 years
Initially 5mg to 15mg daily in divided doses, adjusted depending on child's weight.
Maximum daily dose in children under 40kg is 2mg/kg.
Patients with Renal Impairment
Reduce daily dose by 50%.
Patients with Hepatic Impairment
Severe Hepatic impairment
Contraindicated.
Mild to moderate Hepatic impairment
Reduce daily dose by 33%.
Contraindications
Children under 6 months
Family history of sudden death
Breastfeeding
Cardiovascular disorder
Electrolyte imbalance
Galactosaemia
Long QT syndrome
Porphyria
Pregnancy
Severe bradycardia
Severe hepatic impairment
Torsade de pointes
Precautions and Warnings
Children aged 6 months to 18 years
Elderly
Family history of long QT syndrome
Benign prostatic hyperplasia
Bladder outflow obstruction
Chronic bronchitis
Decreased gastrointestinal motility
Dementia
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of seizures
History of torsade de pointes
Hypertension
Hyperthyroidism
Lactose intolerance
Myasthenia gravis
Narrow angle glaucoma
Pulmonary emphysema
Pyloroduodenal obstruction
Raised intra-ocular pressure
Renal impairment
Stenosing peptic ulcer
Urinary retention
Correct electrolyte disorders before treatment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with moderate renal impairment
Advise impaired alertness may affect ability to drive or operate machinery
Contains lactose
Perform ECG before and during treatment
Monitor serum electrolytes
Advise patient to report any signs of cardiac arrhythmias
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue 7 days before allergy testing
Discontinue 96 hours before methacholine test
Not licensed for all indications in all age groups
Reduce dose in elderly
Maintain treatment for the shortest possible duration
Advise patient to avoid alcohol during treatment
Pregnancy and Lactation
Pregnancy
Hydroxyzine is contraindicated during pregnancy.
Use of hydroxyzine is contraindicated by the manufacturer.
At the time of writing there is limited published data regarding use of hydroxyzine during early pregnancy. Use during the latter part of the third trimester may cause adverse effects in neonates such as irritability, paradoxical excitability, and tremor.
Animal studies have shown reproductive toxicity.
Hydroxyzine crosses the placental barrier leading to higher foetal than maternal concentrations.
Briggs (2015) states that the human data suggest low risk. A surveillance study found an increased risk of oral clefts and other reports of congenital defects were mentioned elsewhere. Seizures have been reported in two newborns exposed near term.
Lactation
Hydroxyzine is contraindicated during breastfeeding.
Use of hydroxyzine when breastfeeding is contraindicated by the manufacturer.
Manufacturer advises hydroxyzine may be excreted into breast milk. The effects on the nursing infant are unknown.
However, the Drugs and lactation database (LactMed) notes that small occasional doses of the drug would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic or before lactation is well established. The non-sedating antihistamines are preferred alternatives.
Side Effects
Abnormal liver function
Acute generalised exanthematous pustulosis
Agitation
Agranulocytosis
Anaphylactic shock
Anaphylaxis
Angioedema
Anorexia
Anxiety
Asthenia
Ataxia
Attention disturbances
Bitter taste
Blood disorders
Blurred vision
Bronchospasm
Chest tightness
Chills
Coma
Confusion
Constipation
Convulsions
Depression
Dermatitis
Diarrhoea
Disorientation
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dry throat
Drying of mucus membranes in the respiratory tract
Dyskinesia
Dysuria
Early menses
Eczema
Epigastric pain
Erythema
Extrapyramidal effects
Faintness
Fatigue
Fixed drug eruption
Flushing
Haemolytic anaemia
Hair loss
Hallucinations
Headache
Hepatic disorders
Hypersensitivity reactions
Hypotension
Impotence
Increase in gastric acid secretion
Increased GI peristalsis
Increased motor activity
Insomnia
Irritability
Labrynthitis
Lassitude
Leucopenia
Maculopapular rash
Malaise
Myalgia
Nasal stuffiness
Nausea
Nightmares
Palpitations
Paraesthesia
Porphyria
Priapism
Prolongation of QT interval
Pruritus
Psychomotor impairment
Pyrexia
Sedation
Seizures
Sleep disturbances
Slurred speech
Somnolence
Stevens-Johnson syndrome
Sweating
Tachycardia
Thickening of bronchial secretions
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urinary retention
Urticaria
Ventricular arrhythmias
Vertigo
Vomiting
Weakness
Wheezing
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: September 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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.
Summary of Product Characteristics: Hydroxyzine 10mg tablets. Morningside Healthcare Ltd. Revised January 2020.
Summary of Product Characteristics: Hydroxyzine 25mg tablets. Morningside Healthcare Ltd. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 September 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Hydroxyzine Last revised: 01 April 2019
Last accessed: 25 September 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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