LARGACTIL

Route of administration:

Deep intramuscular injection. Oral route administration should be used wherever possible. Parenteral formulations may be used in emergencies. They may only be administered by deep intramuscular injection. Largactil is too irritant to give subcutaneously.

Repeated injections should be avoided if possible.

ADULTS:

A single deep intramuscular injection of 25-50mg followed by oral therapy will suffice in many cases, but the intramuscular dose may be repeated if required at 6 to 8 hour intervals. As soon as possible oral administration should be substituted.

ELDERLY:

Should be started on half or even quarter of the adult dosage. m. For acute relief of symptoms 25-50 mg every 6-8 hours. Do not use unless need is life saving. 5 mg/kg bodyweight every 6-8 hours. Dosage is not advised to exceed 40 mg daily.

5 mg/kg bodyweight every 6-8 hours. Dosage is not advised to exceed 75 mg daily. e. 25 mg 8 hourly. m. 25-50 mg and if this fails 25-50 mg in 500- 1000 ml sodium chloride injection by slow intravenous infusion. No information available. m.

25 mg initially then 25-50 mg every 3-4 hours until vomiting stops then drug to be taken orally. Do not use unless need is life saving. 5 mg/kg 6- 8 hourly. It is advised that maximum daily dosage should not exceed 40 mg. 5 mg/kg every 6-8 hours.

It is advised that maximum daily dosage should not exceed 75 mg. Not recommended.

The following CIOMS frequency rating is used, when applicable:

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). 4) Parkinsonism (more common in adults and the elderly.

4), ST depression, U- Wave and T-Wave changes. Cardiac arrhythmias, including Ventricular arrhythmia and atrial arrhythmias, A-V block, Ventricular fibrillation Ventricular tachycardia Torsade de pointes Cardiac arrest has been reported during neuroleptic phenothiazine therapy, possibly related to dosage.

Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose. 6) Reproductive system and breast disorders Priapism General disorders and administration site conditions Temperature regulation disorder Insomnia Agitation 1may be seen without evidence of clinical disease 2particularly at the start of treatment 3particularly during long term treatment; may occur after the neuroleptic is withdrawn and resolve after reintroduction of treatment or if the dose is increased.

4). 7 The development of a metallic greyish-mauve coloration of exposed skin has been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (4 – 8 years). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Largactil should be avoided in patients with: • hypothyroidism • phaeochromocytoma • myasthenia gravis • prostate hypertrophy • known hypersensitivity to phenothiazines • a history of narrow angle glaucoma or agranulocytosis Except under exceptional circumstances, this drug must not be administered to patients with Parkinson’s disease.

5). 5). 8). In those frequently handling preparations of phenothiazines, the greatest care must be taken to avoid contact of the drug with the skin. Blood disorders All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count.

Treatment will be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the latter. As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. 8) and requires immediate haematological investigation.

Neuroleptic malignant syndrome Treatment must be interrupted in the event of unexplained hyperpyrexia since this can be one of the signs of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity).

Signs of autonomic instability, such as hyperhydrosis and irregular blood pressure, can precede the onset of hyperthermia and as such constitute premonitory signs of this syndrome. While this neuroleptic-related effect can be of idiosyncratic origin, certain risk factors such as dehydration and brain damage would seem to indicate a predisposition.

Withdrawal Acute withdrawal symptoms, including nausea, vomiting and insomnia, have very rarely been reported following the abrupt cessation of high doses of neuroleptics. Relapse may also occur, and the emergence of extrapyramidal reactions has been reported.

Therefore, gradual withdrawal is advisable. In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time. QT prolongation Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death).

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