Antihistamines for systemic use; Phenothiazine derivatives - ATC code: R06AD02

promethazine hydrochloride

Each ampoule contains 25mg/ml of the active substance Promethazine hydrochloride.

Also contains 0.5mg of sodium sulphite anhydrous (E221) and 0.7mg of sodium metabisulphite (E223).

Solution for injection.

Phenergan Injection is a clean, bright, colourless or almost colourless solution.

As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.

Sedation and treatment of insomnia in adults.

As an adjunct in preoperative sedation in surgery and obstetrics.

As a paediatric sedative.

Route of administration: Intramuscular or intravenous (after dilution)

The usual dose is 25 - 50 mg by deep intramuscular injection, or, in emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use.

Maximum parenteral dose 100 mg.

Elderly: No specific dosage recommendations.

Children: 6.25 - 12.5 mg for children from 5 - 10 years by deep intramuscular injection. Not for use in children under 2 years of age.

Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.

Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.

Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.

Phenergan should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Phenergan may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.

Use with care in patients 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.

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome.

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene. If a patient complains of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or inadvertent intra-arterial injection. Intramuscular injection must also be performed carefully to avoid inadvertent subcutaneous injection, which could lead to local necrosis.

Phenergan contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm.

Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Phenergan may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required. Phenergan may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required. Phenergan may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. Phenergan should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results. Phenergan injection may increase glucose tolerance.

Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, 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 the anticholinergic effects and confusion due to promethazine. Other side-effects include anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms and tic-like movements of the head and face. Jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Very rare cases of allergic reactions, including urticaria, rash, pruritus and anaphylaxis, have been reported.

Photosensitive skin reactions have been reported; strong sunlight should be avoided during treatment.

sanofi-aventis

POM

23 May 2012