Tazocin (piperacillin/tazobactam): new formulation
- Medicines and Healthcare products Regulatory Agency
- 1 March 2008
- Therapeutic area:
- Infectious disease
Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
Article date: March 2008
Tazocin (piperacillin/tazobactam) now contains additional ingredients and is compatible with a wider range of products. Tazocin (piperacillin/tazobactam) is used to treat a wide range of infections. Because of changes to the European Pharmacopoeia, the medicine has been reformulated and now has 2 additional excipients: edetate disodium dihydrate (EDTA) and citric acid.
These additional excipients have improved the physical compatibility of the medicine. The new formulation of Tazocin is now compatible with lactated Ringer’s (Hartmann’s) solution and, in some circumstances, with aminoglycosides. Although generally the mixing of beta-lactam antibiotics with aminoglycosides can inactivate the aminoglycoside, amikacin and gentamicin are compatible with reformulated Tazocin at specific concentrations.
The addition of EDTA to Tazocin has increased the amount of sodium in the product, which equates to a sodium load of 5·58 mEq (128 mg) per 2·25 g dose of Tazocin and 11·16 mEq (256 mg) sodium per 4·5 g dose of Tazocin.
The new formulation is being launched in March 2008. The marketing authorisation holder, Wyeth, is taking steps to minimise the amount of time the 2 formulations are in the supply chain concurrently. Where appropriate, healthcare professionals should use all existing stock before introducing the reformulated product.
The labelling has been revised to help identify the reformulated product. Pack colours have been changed and all packaging components have been clearly marked as “new formulation”.
Advice for healthcare professionals includes:
- Tazocin has been reformulated and is now compatible with a wider range of products
- sodium load has increased to 5·58 mEq per 2·25 g dose and to 11·16 mEq per 4·5 g dose
- use up existing stock before introducing the reformulated product into clinical areas
- product labelling includes reference to the new formulation to aid identification
Article citation: Drug Safety Update March 2008; Vol 1, issue 8: 3
Published: 1 March 2008
Therapeutic area: Infectious disease