INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo Q-MED PROMAZINE INJECTION 50 mg/mL

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

Q-MED PROMAZINE INJECTION 50 mg/mL

COMPOSITION:
Each 1 mL sterile solution contains
promazine hydrochloride 50 mg with sodium formaldehyde sulfoxylate 0,1% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 2 6.1 Phenothiazines and derivatives

PHARMACOLOGICAL ACTION:
Promazine belongs to the phenothiazine group of agents. Promazine possesses sedative, tranquillising and anti-emetic properties. It has relatively weak antipsychotic activity.

INDICATIONS:
Its main indications are for the short-term management of agitated or disturbed behaviour, alleviation of nausea and vomiting and relief of intractable hiccup.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients is contra-indicated in patients with pre-existing central nervous system depression or coma, bone-marrow suppression, or pheochromocytoma. It should be used with caution or not at all in patients with impaired liver, kidney, cardiovascular, cerebrovascular and respiratory function and in those with closed-angle glaucoma, parkinsonism, diabetes mellitus, hypothyroidism, myasthenia gravis, or prostatic hypertrophy.
Pregnancy and lactation.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants.
Patients should not drive or operate hazardous machinery. Care is required in epileptic patients receiving anticonvulsant therapy as phenothiazines may lower the seizure threshold; they should be avoided if possible in untreated epileptics. Elderly and debilitated patients may be more prone to the adverse effects of promazine.

DOSAGE AND DIRECTIONS FOR USE:
The initial intramuscular dose of promazine hydrochloride for all indications is 50 mg; this may be followed by further doses of 50 to 100 mg as required up to a maximum of 1 gram over 24 hours. Promazine should be given in reduced dosage to elderly subjects.
The injections may also be administered intravenously, but care should be taken to avoid local reactions and the concentrations of the solution should not exceed 25 mg/mL.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Promazine has antimuscarinic properties and may cause adverse effects such as dry mouth, constipation, difficulty with micturition, blurred vision and mydriasis. Tachycardia, electrocardiographic changes may occur.
Hypotention (usually postural) is common. Other adverse effects include delirium, agitation and, rarely, catatonic-like states, insomnia, depression, miosis, EEG changes and convulsions, nasal congestion, minor abnormalities in liver function tests, inhibition of ejaculation, impotence and priapism.
Hypersensitivity reactions include urticaria, exfoliative dermatitis, erythema multiforme, and contact sensitivity. A syndrome resembling systemic lupus erythematosus has been reported.
Prolonged therapy may lead to deposition of pigment in the skin, or more frequently the eyes; corneal and lens opacities have been observed.
Various haematological disorders, haemolytic anaemia, aplastic anaemia, thrombocytopenic purpura and a potentially fatal agranulocytosis have occasionally been reported in patients receiving promazine
Promazine produces extrapyramidal dysfunction probably as a result of their effects on central dopaminergic transmission. Resultant disorders include acute dystonia, a parkinsonism-like syndrome, and akathisia; late effects include tardive dyskinesia and perioral tremor.
Promazine alters endocrine and metabolic functions. Patients have experienced amenorrhoea, galactorrhoea; gynaecomastia, weight gain and hyperglycaemia and altered glucose tolerance. Body temperature regulation is impaired and may result in both hypo- or hyperthermia depending on environment.
Interactions:
Symptoms of central nervous system-depression may be enhanced by other agents with central nervous system-depressant properties, including alcohol, general anaesthetics, hypnotics and sedatives and opioid anaesthetics.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See Side-effects and Special Precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear colourless to pale yellow solution.

PRESENTATION:
1 mL amber ampoules in packs of 10.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
30/2.6.1/0340

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9701

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1997

                                PPR 0031/12-97

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