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Logo PROMAZINE HYDROCHLORIDE INJECTION INTRAMED 50mg/mL

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PROMAZINE HYDROCHLORIDE INJECTION INTRAMED 50mg/mL

COMPOSITION:
Each mL of sterile solution contains
promazine hydrochloride 50 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 26.1 –Phenothiazines and derivatives.

PHARMACOLOGICAL ACTION:
Promazine belongs to the phenothiazine group of drugs. The actions of Promazine are sedation, tranquillisation, alteration of sleep patterns, lowering of conditioned response in test animals, decrease of spontaneous motor activity, alteration of electroencephalogram pattern, lowering of the convulsive threshold, dopamine receptor block, alteration of body temperature regulation and endocrine function, depression of brain stem function, anti-emesis caused by drugs, weak cholinergic and alpha adrenergic blocking actions, alterations in skeletal muscle tone and movement.

INDICATIONS:
Mania
Agitation organic brain syndrome
Alcoholic hallucinosis
Drug induced emesis
Radiation sickness
Intractable hiccough

CONTRA-INDICATIONS:
Promazine is contra-indicated in comatose patients (particularly those under the influence of alcohol, barbiturates, narcotics or other central nervous system depressants) an in patients with bone marrow depression. Promazine should not be given to patients being treated with drugs that might cause leucopenia. Women who may become pregnant.

WARNINGS:

DOSAGE AND DIRECTIONS FOR USE:
Administer 50 - 100 mg promazine hydrochloride by intramuscular injection. The injection may also be administered intravenously but care should be taken to avoid local reactions and the concentration of the solution should not exceed 25 mg/mL. Promazine injection may be diluted with sodium chloride injection. The total daily dose must not exceed 1 g because of the risk of convulsions.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include drowsiness, dryness of mouth, pallor of the skin, postural hypotension, weakness, lowering of body temperature (occasionally pyrexia), tachycardia, arrhythmias, agitation, insomnia, depression, photosensitivity and skin rashes.
Obstructive jaundice, constipation, faecal compaction, thromboembolism following intravenous injection, agranulocytosis, leucopenia, leucocytosis, haemolytic anaemia, amenorrhoea, galactorrhoea, gynaecomastia, mass gain, diabetes mellitus, raised serum cholesterol concentration, and extra pyramidal side-effects may occur. The extra-pyramidal side-effects are generally reversible or may be treated with anti-Parkinsonian agent: however, if persistent tardive dyskinesia occurs, it may be irreversible.
A lupus erythematosus - like syndrome, deposition of purplish pigment in exposed skin and eyes, opacification of the lens and cornea have been reported with the use of phenothiazines.
Promazine should be used with extreme caution in patients with cardiovascular disease or phaeochromocytoma or other conditions where a sudden drop in blood pressure would be undesirable. Use with caution in patients with existing tachycardia, cardiac insufficiency, liver dysfunction, a history of jaundice or Parkinsonian.
After sudden cessation of treatment with large doses, withdrawal symptoms e g. nausea, vomiting, gastritis and tremors, may occur. Doses of other CNS depressants (e.g. alcohol, anaesthetics, hypnotics), drugs with anticholinergic action (e.g. atropine, tricyclic antidepressants) or drugs which cause postural hypotension, may have to be reduced if used in conjunction with promazine. Promazine may lower the anti-hypertensive effect of guanethidine. Cardiovascular reactions may occur if promazine and pethidine are administered concomitantly.
The anticonvulsant action of barbiturates are not enhanced by promazine.
Drowsiness may be marked, on initiation of treatment with promazine and patients should be advised not to drive vehicles or take charge of machinery during this period. Use with caution in elderly and debilitated patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypothermia, acute hypotension, central nervous system depression, severe extra-pyramidal reactions. A slow intravenous injection of an antimuscarinic such as benztropine mesylate 1 - 2 mg, diphenhydramine hydrochloride 25 to 50 mg or procyclidine hydrochloride 10 mg may be given to treat severe extrapyramidal reactions. Treatment of other manifestations is symptomatic.

IDENTIFICATION:
A clear colourless solution.

PRESENTATION:
Containers with 10 x 1 mL ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
M/2.6.1/284

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
PORT ELIZABETH
6001

DATE AND PUBLICATION OF THIS PACKAGE INSERT:
JANUARY 1981 12-365/1-95
  Tradepak PE

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