CYCLIZINE Tablet Ref.[9318] Active ingredients: Cyclizine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Therapeutic indications

Cyclizine Hydrochloride is indicated in adults and in children aged 6 years and over for the prevention and treatment of nausea and vomiting including:

  • Motion sickness.
  • Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.
  • Vomiting associated with radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels.

Cyclizine Hydrochloride may be of value in relieving vomiting and attacks of vertigo associated with Meniรจre’s disease and other forms of vestibular disturbance.

Posology and method of administration

Posology

To prevent motion sickness Cyclizine Hydrochloride should be taken about one to two hours before departure.

Elderly

There have been no specific studies of Cyclizine Hydrochloride in the elderly. Experience has indicated that normal adult dosage is appropriate.

Paediatric population

Children less than 6 years of age: Cyclizine Hydrochloride tablets are not recommended for children less than 6 years of age.

Children 6 to 12 years of age: 25 mg orally, which may be repeated up to three times a day.

Children over 12 years of age: 50 mg orally, which may be repeated up to three times a day.

Adults

50 mg orally, which may be repeated up to three times a day.

Method of administration

Oral.

Overdose

Symptoms

Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic effects and effects on the central nervous system.

Peripheral anticholinergic symptoms include dry mouth, nose and throat, blurred vision, tachycardia and urinary retention. Central nervous system effects include drowsiness, dizziness, incoordination, ataxia, weakness, hyperexcitability, disorientation, impaired judgement, hallucinations, hyperkinesia, extrapyramidal motor disturbances, convulsions, hyperpyrexia and respiratory depression.

An oral dose of 5 mg/kg is likely to be associated with at least one of the clinical symptoms stated above. Younger children are more susceptible to convulsions. The incidence of convulsions, in children less than 5 years, is about 60% when the oral dose ingested exceeds 40 mg/kg.

Management

In the management of acute overdosage with Cyclizine Hydrochloride, gastric lavage and supportive measures for respiration and circulation should be performed if necessary. Convulsions should be controlled in the usual way with parenteral anticonvulsant therapy.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Store below 25ยฐC.

Nature and contents of container

Amber glass or polyethylene bottles with polyethylene tamper evident caps for pack size 100 tablets.

Special precautions for disposal and other handling

No special requirements.

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