VALOID Solution for injection Ref.[50281] Active ingredients: Cyclizine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland.

4.1. Therapeutic indications

Valoid is indicated in adults for the prevention and treatment of nausea and vomiting, including:

  • Motion sickness, when the oral route cannot be used.
  • 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.
  • Valoid Injection, by the intravenous route, is also indicated pre-operatively in patients undergoing emergency surgery in order to reduce the hazard of regurgitation and aspiration of gastric content during induction of general anaesthesia.

Valoid may be of value in relieving vomiting and attacks of vertigo associated with Meniรจre’s disease and other forms of vestibular disturbance when the oral route cannot be used.

4.2. Posology and method of administration

Posology

For the prevention of postoperative nausea and vomiting, administer the first dose by slow intravenous injection 20 minutes before the anticipated end of surgery.

Adults

50 mg intramuscularly or intravenously up to three times daily.

When used intravenously, Valoid Injection should be injected slowly into the bloodstream, with only minimal withdrawal of blood into the syringe.

Cyclizine given intravenously, in half the recommended dose, increases the lower oesophageal sphincter tone and thereby reduces the hazard of regurgitation and aspiration of gastric contents if given to patients, undergoing emergency surgery, before induction of general anaesthesia.

Elderly

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

Paediatric population

Not licensed for use in children.

Method of Administration

Intramuscularly or intravenously.

4.9. 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 five years, is about 60% when the oral dose ingested exceeds 40 mg/kg.

Management:

In the management of acute overdosage with Valoid 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

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25ยฐC.

Keep the ampoule in the outer carton in order to protect it from direct sunlight.

6.5. Nature and contents of container

1 ml neutral glass ampoules.

Five ampoules in a carton.

6.6. Special precautions for disposal and other handling

For single use only. Discard any unused contents.

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