DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP 50 MG/2 ML [SIN02707P]

Product Info

DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP 50 MG/2 ML

[SIN02707P]

Indication

4.1 Therapeutic Indications

DBL™ Promethazine Hydrochloride Injection BP is indicated for the following conditions:

Treatment of allergic reactions such as:

• uncomplicated allergic conditions of the immediate type, e.g., pruritus, urticaria and angioedema, when oral therapy is impossible or contraindicated.

Treatment and prevention of vomiting including:

• motion sickness;

• drug induced nausea;

• prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery, such as procedures with a high incidence of post-operative vomiting (e.g., gynaecological surgery, strabismus or middle ear surgery, and electroconvulsive therapy); in patients with a past history of motion sickness or post-operative vomiting; and in patients in whom avoidance of vomiting is crucial (e.g., neurosurgery and eye surgery).

Promethazine has sedative effects and it is also used in:

• pre-operative, post-operative and obstetric (during labour) sedation.

Dosing

4.2 Dose and Method of Administration

Dosage

Allergic conditions

Adults: 25 mg to 50 mg by deep intramuscular injection or slow intravenous injection; may be repeated within two hours if necessary. Maximum dose up to 150 mg daily.

Antiemetic

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In established nausea or vomiting due to causes other than motion sickness:

Adults: 12.5 to 25 mg, by intramuscular or intravenous injection, every four hours as needed.

Children: 5 to 12 yrs old – 12.5 mg by intramuscular injection.

Sedative/hypnotic

Adults: 25 to 50 mg by intramuscular or intravenous injection.

Children: When oral route is not possible;

2 to 5 yrs old – 7.5 to 10 mg by intramuscular injection.

6 to 10 yrs old – 10 to 12.5 mg by intramuscular injection.

Pre-operative and post-operative sedation

Adults: 25 to 50 mg by intramuscular or intravenous injection, usually with pethidine and atropine.

Obstetric sedation

Early stages of labour: 50 mg, by intramuscular injection. Established labour: 25 to 75 mg, by intramuscular or intravenous injection, with an appropriately reduced dose of an opioid analgesic. May be repeated once or twice at four hourly intervals during the course of the labour, if necessary. Total dose should not exceed 100 mg in 24 hours.

Method of Administration

All routes of administration can cause damage to tissues (see sections 4.8 Contraindications and 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Deep Intramuscular Injection is the preferred route of administration of DBL™ Promethazine Hydrochloride Injection BP.

Promethazine should only be administered intravenously if the benefits outweigh the risks in an individual patient. This may include emergency situations or situations where IM injections are contraindicated (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Extreme care must be taken to avoid extravasation or intra-arterial injection. Injections should be stopped immediately if a patient complains of pain during injection (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If venous administration is required, a large vein should be used. Administration via a venous site in the hand or wrist should be avoided if possible due to an increased risk of tissue injury.

When given intravenously, DBL™ Promethazine Hydrochloride Injection BP 50 mg/2 mL should be diluted 1 in 10 with water for injections or preferably given through the tubing of a freely flowing IV infusion. It should be injected slowly at a rate of administration not greater than 25 mg/minute (i.e. 10 mL/minute of dilute solution).

Rapid intravenous infusion may cause a transient fall in blood pressure and may increase the risk of severe tissue injuries. Promethazine should not be given intra-arterially or subcutaneously (see section 4.8 Contraindications).

Contraindications

4.3 Contraindications

Promethazine is contraindicated for use in paediatric patients less than two years of age because of the potential for fatal respiratory depression. Post marketing cases of respiratory depression including fatalities have been reported with the use of promethazine in paediatric patients less than two years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Promethazine is contraindicated in patients who have exhibited hypersensitivity to the drug or other phenothiazine derivatives.

Promethazine is also contraindicated in the following patients:

• Comatose;

• after administration of large doses of other CNS depressants (e.g., alcohol, general anaesthetics, opioid analgesics, tranquillisers, etc.).

Intra-arterially administration of DBL™ Promethazine Hydrochloride Injection BP is contraindicated due to the likelihood of severe arteriospasm and the possibility of resultant gangrene.

Subcutaneous administration of DBL™ Promethazine Hydrochloride Injection BP is contraindicated, as the solution is an irritant and may produce necrotic lesions.