Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aventis Pharma Limited, One Onslow StreetGuildford, Surrey, GU1 4YS, UK or trading as Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Nozinan is a neuroleptic with indications in psychiatry and general medicine, particularly in terminal illness. Clinically it is more sedative and more potent than chlorpromazine in the management of psychotic conditions and in the relief of severe chronic pain.
As an alternative to chlorpromazine in schizophrenia especially when it is desirable to reduce psychomotor activity.
Adjunct therapy in the relief of pain and the accompanying distress.
Dosage varies with the condition under treatment and the individual response of the patient.
Nozinan tablets 25mg may be substituted for the injection if oral therapy is more convenient, the dosage being 12.5mg to 50mg every 4 to 8 hours.
No specific dosage recommendations.
Ambulant patients: initially the total daily oral dose should not exceed 25mg to 50mg usually divided into 3 doses; a larger portion of the dosage may be taken at bedtime to minimise diurnal sedation. The dosage is then gradually increased to the most effective level compatible with sedation and other side effects.
Bed patients: initially the total daily oral dosage may be 100mg to 200mg, usually divided into 3 doses, gradually increased to 1g daily if necessary. When the patient is stable attempts should be made to reduce the dosage to an adequate maintenance level.
Children are very susceptible to the hypotensive and soporific effects of levomepromazine. It is advised that a total daily oral dosage of 11⁄2 tablets should not be exceeded. The average effective daily intake for a ten year old is 1⁄2 to 1 tablet.
It is not advised to give levomepromazine to ambulant patients over 50 years of age unless the risk of a hypotensive reaction has been assessed.
Symptoms of levomepromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias hypothermia and convulsions. Severe extrapyramidal dyskinesias may occur.
If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.
Generalised 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 antiarrhythmic 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:
Not all pack sizes may be marketed.
Store below 25°C. Store in original container and protect from light.
PVC/PVdC/aluminium foil blister pack containing 84 tablets.
OR
High density polyethylene bottle with flip cap or polypropylene tablet container.
Each pack contains 500 tablets.
Not all pack sizes may be marketed.
None.
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