NOZINAN Solution for injection / infusion Ref.[7297] Active ingredients: Levomepromazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Therapeutic indications

Management of the terminally ill patient. Levomepromazine resembles chlorpromazine and promethazine in the pattern of its pharmacology. It possesses anti-emetic, antihistamine and anti-adrenaline activity and exhibits a strong sedative effect.

Nozinan potentiates the action of other central nervous system depressants but may be given in conjunction with appropriately modified doses of narcotic analgesics in the management of severe pain. Nozinan does not significantly depress respiration and is particularly useful where pulmonary reserve is low.

Nozinan is indicated in the management of pain and accompanying restlessness or distress in the terminally ill patient.

Posology and method of administration

Intramuscular and intravenous injection

Dosage varies with the condition and individual response of the patient. Nozinan injection may be administered by intramuscular injection or intravenous injection after dilution with an equal volume of normal saline.

The usual dose for adults and the elderly is 12.5mg to 25mg (0.5ml to 1ml) by intramuscular injection, or by the intravenous route after dilution with an equal volume of normal saline immediately before use. In cases of severe agitation, up to 50mg (2ml) may be used, repeated every 6 to 8 hours.

Continuous subcutaneous infusion

Nozinan injection may be administered over a 24 hour period via a syringe driver. The required dose of Nozinan injection (25mg to 200mg per day) should be diluted with the calculated volume of normal saline. Diamorphine hydrochloride is compatible with this solution and may be added if greater analgesia is required.

Nozinan tablets 25mg may be substituted for the injection if oral therapy is more convenient.

Children

Clinical experience with parenteral levomepromazine in children is limited. Where indicated, doses of 0.35mg/kg/day to 3.0mg/kg/day are recommended.

Overdose

Symptoms of levomepromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias, hypothermia and convulsions. Severe extrapyramidal dyskinesias may occur.

General vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice but, in severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended; avoid use of adrenaline (epinephrine).

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life-threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine (lignocaine) and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5mg to 10mg) or orphenadrine (20mg to 40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam. Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Protect from light.

Nature and contents of container

Colourless type I glass ampoule. Each pack contains 10 ampoules.

Special precautions for disposal and other handling

Nozinan may be administered by intramuscular injection or intravenous injection after dilution with an equal volume of normal saline, or by continuous subcutaneous infusion with an appropriate volume of normal saline.

Diamorphine hydrochloride is compatible with this solution.

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