24 Nov, 14 | by James Smallbone, Publishing Assistant
Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Dexamethasone 4mg/mL injection changes
Dexamethasone injection 4mg/mL (Organon) has been acquired by Aspen pharmaceuticals. They have reformulated the product and it now contains 3.8mg/mL dexamethasone, available as a 1mL vial, which requires storage in a fridge, see the SPC for further details. Other dexamethasone injectable formulations in the UK are 3.3mg/mL (Hameln and Hospira), available as 1mL glass ampoules and do not require refrigeration.
These changes have implications for prescribing, administration and storage, and increase the risk of confusion and error. The MHRA has highlighted the issues in the October 2014 Drug Safety Update and UK Medicines Information (UKMI) has produced a safety assessment report summarizing the changes, the differences between the products and the potential next steps.
Diclofenac dose reduced in Canada
Health Canada has reduced the maximum daily dose of diclofenac tablets and suppositories to 100mg/day following a safety review. In addition, diclofenac is not recommended in patients with cerebrovascular disease or with known (or risk factors for) cardiovascular disease. The review was undertaken following the publication of the study in 2013 (Bhala N et.al Lancet 382:769-79) which indicated that the cardiovascular risks of high dose diclofenac were comparable to COX-2 inhibitors. For further information, click here.
Buscopan and baclofen confusion
UKMI has highlighted the risk of confusion between Buscopan® 10mg tablets (hyoscine butylbromide) and baclofen 10mg tablets, following numerous reported medication errors. The majority of errors occurred whilst dispensing although some have occurred whilst prescribing or administering. Recommendations by UKMI on managing this risk have been made in a product safety assessment report.
Zolpidem updated SPC
Strengthened warnings regarding the risk of drowsiness and reduced driving ability, use in the elderly and in liver impairment have been added to the zolpidem SPC. This follows a European review and an MHRA Drug Safety Update highlighting these risks earlier in the year. The changes include advising patients:
- not to re-administer the dose during the same night
- not to drive, operate machinery, or work at heights until at least 8 hours after taking zolpidem and if they are still drowsy
- not to take zolpidem with alcohol, illicit drugs, or other central nervous system suppressants.
In addition, a maximum of 5mg at night is recommended for people with liver impairment and the elderly. For the SPC, click here.
The following Cochrane reviews have been published in full on-line:
- the use of codeine, alone and with paracetamol for cancer pain (CD006601)
- the use of desipramine for neuropathic pain in adults (CD011003).
British guideline on the management of asthma updated
The British guidelines on the management of asthma (SIGN 141), produced jointly by the British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN) have been updated. For more information, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock