CYCLIZINE LACTATE

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 • 50mg intramuscularly or intravenously up to three times daily.

• When used intravenously, cyclizine should be injected slowly into the bloodstream, with only minimal withdrawal of blood into the syringe. • For the prevention of post operative nausea and vomiting, administer the first dose by slow intravenous injection 20 minutes before the anticipated end of surgery.

• 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 cyclizine 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

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.

The following undesirable effects have been reported with a frequency of Not known. System Organ Class Frequency Adverse reactions Blood and lymphatic system disorders Not known Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia.

4) Ear and labyrinth disorders Not known Tinnitus. There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. Eye disorders Not known Blurred vision, oculogyric crisis Gastrointestinal system disorders Not known Dryness of the mouth, nose and throat, constipation, increased gastric reflux, nausea, vomiting, diarrhoea, stomach pain, loss of appetite.

General disorders and administration site conditions Not known Asthenia, malaise Injection site reactions including vein tracking, erythema, pain, thrombophlebitis and blisters. A sensation of heaviness, chills and pruritus have been reported rarely.

Rapid IV administration can lead to symptoms similar to overdose. 4), hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine. Immune system disorders Not known Hypersensitivity reactions, including anaphylaxis have occurred.

Musculoskeletal and connective tissue disorders Not known Twitching, muscle spasms Nervous system disorders Not known Effects on the central nervous system have been reported with cyclizinethese include somnolence, drowsiness, incoordination, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, restless leg syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, paralysis* and generalised chorea.

As with other anticholinergic agents, cyclizine may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, urinary retention, obstructive disease of the gastrointestinal tract, hepatic disease, pheochromocytoma, hypertension, epilepsy and in males with possible prostatic hypertrophy.

Cyclizine injection may have a hypotensive effect. Cyclizine should be used with caution in patients with severe heart failure or acute myocardial infarction. In such patients, cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure.

Cyclizine should be avoided in porphyria. There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects. 5). Case reports of paralysis have been received in patients using intravenous cyclizine.

Some of the patients mentioned in these case reports had an underlying neuromuscular disorder. Thus, intravenous cyclizine should be used with caution in all patients and with particular care in patients with underlying neuromuscular disorders.

1. Cyclizine is contraindicated in the presence of acute alcohol intoxication. The anti-emetic properties of cyclizine may increase the toxicity of alcohol.