HPS Pharmacies wish to advise that Pfizer is continuing to experience a supply interruption for promethazine ampoules as follows:
DBL™ Promethazine Hydrochloride Ampoules
Promethazine hydrochloride 50mg/2mL
ARTG 16255
Normal supplies are expected to resume from the end of December 2027.
Internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. There are important differences between these products that should be considered before use, particularly regarding dilution requirements and routes of administration. Key differences are summarised in the table below.
Note: Promethazine is highly caustic and may cause severe tissue injury if administered incorrectly. Preparation and administration should be undertaken with caution. Healthcare professionals are encouraged to review the relevant product information and supporting resources before use, including the documents linked in the table below.
| DBL™ Promethazine | XGen Promethazine (USA) | Promethazin-Neuraxpharm (German) | |
| Strength | 50 mg/2 mL | 25 mg/1 mL | 50 mg/2 mL |
| Presentation | 2 mL glass ampoules (Pack of 5) |
1 mL glass ampoules (Pack of 25) |
2 mL glass ampoules (Pack of 5) |
| Excipients | Disodium edetate Glacial acetic acid Sodium acetate Sodium metabisulfite Water for injection |
Acetic acid Calcium chloride Edetate sodium Phenol Sodium acetate Sodium metabisulfite Water for injection |
Ascorbic acid Hydrochloric acid 10% Sodium chloride Sodium citrate Sodium metabisulfite Sodium sulfite Water for injection |
| pH | 5 – 6 | 4 – 5.5 | Not specified |
| Label language | English | English | German |
| Preferred route | Deep IM injection | ||
| Administration | IV injection
|
IV injection/infusion
|
IV administration unsuitable due to lack of dilution and compatibility information. |
| Caution | Subcutaneous route contraindicated for all products | ||
| Storage | Below 25°C. Protect from light. |
20-25°C. Protect from light. |
Below 25°C. Protect from light. |
| Additional information | Product information | Dear Health Care Professional Letter (USA) | Dear Health Care Professional Letter (Germany) |
Please note that S19A products also have a longer lead time and different pricing as they must be sourced internationally.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines, or medical devices to the TGA.
Should you require further information regarding this matter, please contact Pfizer on 1800 675 229, or your pharmacist at HPS Pharmacies.
Subscribe Knowledge Centre Updates
Enter your details to receive Knowledge Centre updates