Each 1ml of solution contains Promethazine Hydrochloride Injection B.P. 2.5% w/v.

Colourless or almost colourless sterile solution for injection intended for parenteral administration to human beings.

Promethazine Hydrochloride Injection B.P. 2.5% w/v is indicated

1. in the management of allergic conditions for its anti-histamine properties

2. as an anaesthetic pre-medication for its sedative, anti-emetic and anti-secretory effects

3. for sedation and hypnosis.

Method of administration: Deep intramuscular injection. In emergencies, Promethazine Hydrochloride Injection B.P. 2.5% w/v may be administrated by slow intravenous injection after dilution (see dosage information).

Adults:

The usual adult dose is 25 to 50mg by deep intramuscular injection.

In emergency situation, a 2.5% w/v solution (equivalent to 25mg Promethazine Hydrochloride in 1ml) may be diluted to 10 times its volume with Water for injection and administered by slow intravenous injection at a rate not exceeding 25mg per minute. The maximum parenteral dose is 100mg.

Children aged 5 to 10 years may be given a dose of 6.25 to 12.5mg by deep intramuscular injection.

There are no specific dosage recommendation for elderly patients.

Promethazine Hydrochloride Injection B.P. should not be used in patients who are in coma or suffering from CNS depression of any cause. It must not be given to patient who are hypersensitive to phenothiazines or to any of the ingredients in the formulation. It should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days.

Because promethazine may thicken or dry lung secretions and impair expectoration, it should be used with caution in patients with asthma, bronchitis or bronchiectesis. It should be used with care in patient with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency. Caution should be exercised in patients with bladder-neck or pyloro-duodenal obstruction. Promethazine may mask the warning signs of ototoxicity caused by totoxic drugs such as salicylates. By suppressing vomiting, promethazine may delay the early diagnosis of intestinal obstruction or raised intracranial pressure. Accidental intra-arterial injection may lead to peripheral gangrene and necrosis. Subcutaneous injection may lead to local necrosis.

Promethazine hydrochloride should not be used in children under the age of two. Caution should be exercised when administering Promethazine HCl medications to paediatric patients two years of age and older.

Promethazine may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment.

Promethazine may interfere with immunologic urine pregnancy tests and produce false positive or false negative results.

Before commencing skin tests using allergen extracts, promethazine should be discontinued for at least 72 hours as it may inhibit the cutaneous histamine response, thus producing false negative results.

Patients, especially if they are elderly, on anti-hypertensive therapy may require adjustment of dosage to avoid postural hypotension.

Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headache, nightmares, tiredness and disorientation. Anticholinergic side-effects such as blurred vision, dry mouth and urinary retention occur occasionally. Newborn and premature infants are susceptible to the anticholinergic effects of promethazine while other children may display paradoxical hyperexcitability.

The elderly are particularly susceptible to anticholinergic effects and confusion due to promethazine. Other sideeffects include anorexia, gastrointestinal disturbance, palpitation, hypotension, arrhythmias, extrapyramidal effects, muscle spasm and tic-like movement of the head and face. Anaphylaxis, jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Photosensitivity skin reaction have been reported and strong sunlight should be avoided during treatment. The preservatives in promethazine hydrochloride Injection B.P. have been reported to cause hypersensitivity reactions, characterised by circulatory collapse with CNS depression, in certain susceptible individuals with allergic tendencies.

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