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Presentation

Oral formulations of alimemazine tartrate.

Drugs List

  • ALFRESED 30mg/5ml syrup
  • ALFRESED 7.5mg/5ml syrup
  • alimemazine 10mg tablets
  • alimemazine 10mg/5ml oral solution sugar-free
  • alimemazine 30mg/5ml oral solution
  • alimemazine 30mg/5ml oral solution sugar-free
  • alimemazine 7.5mg/5ml oral solution
  • alimemazine 7.5mg/5ml oral solution sugar-free
  • ITZENAL 30mg/5ml oral solution sugar-free
  • ITZENAL 7.5mg/5ml oral solution sugar-free
  • Therapeutic Indications

    Uses

    Premedication - sedative
    Pruritus - general
    Urticaria

    Dosage

    Adults

    Urticaria and Pruritus
    10mg two to three times a day.
    A maximum of 100mg per day has been used in intractable cases.

    Elderly

    Urticaria and Pruritus
    10mg once to twice a day.

    Children

    Not all formulations are suitable for use in children under 12 years and some products are not licensed for use in children under 3 years.

    Urticaria and Pruritus
    Children over 12 years: 10mg two to three times a day. A maximum of 100mg per day has been used in intractable cases.

    Children aged 2 to 12 years: 2.5mg to 5mg three to four times a day.

    Children aged 6 months to 2 years (unlicensed): 250micrograms/kg (maximum 2.5mg) three to four times a day.

    Pre-anaesthetic medication

    Children aged 2 to 7 years: The maximum recommended dose is 2mg/kg one to two hours before the operation.

    The following alternative dosing schedule may be suitable:

    Urticaria and Pruritus

    Children aged 5 to 12 years: 5mg three to four times a day.

    Children aged 2 to 5 years: 2.5mg three to four times a day.

    Contraindications

    Children under 6 months
    Benign prostatic hyperplasia
    Breastfeeding
    Epileptic disorder
    Hepatic impairment
    History of agranulocytosis
    History of narrow angle glaucoma
    Hypothyroidism
    Long QT syndrome
    Myasthenia gravis
    Parkinson's disease
    Phaeochromocytoma
    Renal impairment
    Torsade de pointes

    Precautions and Warnings

    Children aged 6 months to 2 years
    Elderly
    Family history of long QT syndrome
    Cardiovascular disorder
    Electrolyte imbalance
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    History of seizures
    History of torsade de pointes
    Hypokalaemia
    Lactose intolerance
    Pregnancy

    Correct electrolyte disorders before treatment
    Advise patient drowsiness may affect ability to drive or operate machinery
    May contain sodium benzoate: mild mucous membrane irritant
    Some brands contain metabisulfite, may cause bronchospasm/allergies
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Some formulations contain sucrose
    Some formulations may contain alcohol
    Avoid contact of product with skin
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor serum electrolytes
    Not licensed for all indications in all age groups
    Advise patient to avoid alcohol during treatment
    Advise patient to avoid exposure to direct sunlight

    Pregnancy and Lactation

    Pregnancy

    Use alimemazine tartrate with caution during pregnancy.

    The manufacturer notes that alimemazine tartrate should only be used in pregnancy if essential. There is little data on its use in pregnant women. Some phenothiazines have been shown to have harmful effects in animal studies. Neuroleptics may occasionally prolong labour, hence should be suspended until the cervix is dilated 3 to 4cm. Possible adverse effects on the neonate include lethargy or paradoxical hyperexcitability, tremor and low Apgar score.

    Lactation

    Alimemazine tartrate is contraindicated during breastfeeding.

    The manufacturer notes that phenothiazines may be excreted in milk and that breast feeding should be suspended during treatment.

    Side Effects

    Acute dystonias
    Agitation
    Agranulocytosis
    Akathisia
    Akinesia
    Alteration of autonomic nervous system
    Altered consciousness
    Amenorrhoea
    Anaphylaxis
    Angioedema
    Antimuscarinic effects
    Arrhythmias
    Atrioventricular block
    Blood disorders
    Blurred vision
    Bronchospasm
    Cardiac arrhythmias
    Confusion
    Constipation
    Contact sensitisation
    Convulsions
    Depression
    Dizziness
    Drowsiness
    Dry mouth
    Dyskinesia
    ECG changes
    Excitement (paradoxical)
    Extrapyramidal effects
    Fever
    Galactorrhoea
    Gastro-intestinal symptoms
    Glaucoma (closed angle)
    Gynaecomastia
    Headache
    Hepatic impairment
    Hyperprolactinaemia
    Hypersensitivity reactions
    Hyperthermia
    Hypotension
    Impotence
    Insomnia
    Jaundice
    Leukopenia
    Nasal stuffiness
    Neuroleptic malignant syndrome
    Ocular changes
    Pallor
    Palpitations
    Parkinsonism
    Photosensitivity
    Postural hypotension
    Prolongation of QT interval
    Psychomotor impairment
    Rash
    Respiratory depression
    Rigidity
    Sedation
    Sleep disturbances
    ST depression
    T-wave changes
    Tardive dyskinesia
    Tremor
    U-wave changes
    Urinary retention
    Ventricular fibrillation
    Ventricular tachycardia

    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: March 2021

    Reference Sources

    Summary of Product Characteristics: Alfresed 7.5mg/5ml Syrup. Thame Laboratories. Revised July 2020.

    Summary of Product Characteristics: Alfresed 30mg/5ml Syrup. Thame Laboratories. Revised July 2020.

    Summary of Product Characteristics: Alimemazine Tartrate 10mg Film Coated tablets. Zentiva. Revised June 2020.

    Summary of Product Characteristics: Alimemazine Tartrate 10mg/5ml Oral Solution, sugar free. Lucis Pharma Ltd. Revised February 2021.

    Summary of Product Characteristics: Alimemazine Tartrate 7.5mg/5ml Oral Solution. Zentiva. Revised December 2020.

    Summary of Product Characteristics: Alimemazine Tartrate 30mg/5ml Oral Solution. Zentiva. Revised December 2020.

    Summary of Product Characteristics: Alimemazine Tartrate 7.5mg/5ml Syrup. Zentiva. Revised June 2020.

    Summary of Product Characteristics: Alimemazine Tartrate 30mg/5ml Syrup. Zentiva. Revised June 2020.

    Summary of Product Characteristics: Itzenal 7.5mg/5ml Oral Solution, Sugar-Free. Zentiva Pharma UK Ltd. Revised December 2021.

    Summary of Product Characteristics: Itzenal 30mg/5ml Oral Solution, Sugar-Free. Zentiva Pharma UK Ltd. Revised December 2021.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 May 2022

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