Nystatin dose changes in the BNF and SPC

28th April 2017

The dose for oral candidosis in the BNF and all the SPCs for nystatin 100,000units/mL oral suspension, is now 1mL PO q.d.s.. There has been recent confusion over the authorized dose with generic and proprietary SPCs including differing dose schedules. The dose in the Nystan (Sqibb) SPC was increased in September 2016 from 1mL to 4−6mL q.d.s., but has now been changed back to 1mL q.d.s. This was after further discussion with the MHRA who re-assessed the evidence and did not find it robust enough to support the dose increase. 

Editor’s note: PCF has always recommended a higher dose of nystatin oral suspension 100,000units/mL of 5mL PO q.d.s. for oral candidosis. Nystatin is a topical treatment and few people have the oral dexterity to cover the relevant areas with just 1mL, i.e. it is an issue of volume and not the dose itself. The authorized dose in the USA is 4−6mL q.d.s.

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FDA restricts codeine and tramadol in children and adolescents

26th April 2017

As part of an on-going safety review, the FDA have now further restricted the use of codeine and tramadol. The following restrictions apply:

• codeine is contra-indicated for the treatment of pain or cough in children <12 years
• tramadol is contra-indicated for the treatment of pain in children <12 years
• codeine and tramadol are contra-indicated in children <18 years to treat pain after surgery to remove the tonsils and/or adenoids
• it is recommended that codeine and tramadol are not used in adolescents 12−18 years who are obese, or have conditions such as obstructive sleep apnoea or severe lung disease, which may increase the risk of serious breathing problems
• it is recommended that codeine and tramadol are not used by breastfeeding mothers.

Editor’s note: The restrictions for codeine reflect those issued in the UK by the MHRA in April 2015 (for cough) and July 2013 (for pain). The MHRA have not specifically highlighted any restrictions in the UK for tramadol, currently tramadol is unauthorized for use in children <12 years.

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Fentanyl lozenges (Actiq) risk minimization guides

24th April 2017

As part of the terms of the Marketing Authorization for Actiq (fentanyl lozenges; Teva), the company have published the following educational guides to minimize risk of misuse/pharmacodependence, abuse, medication errors, drug diversion, accidental exposure, overdose, off-label use, respiratory depression and dental decay in patients on opioids.

Prescription guide

Patient guide

Patient treatment diary

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End of life care for infants, children and young people: quality standard consultation

24th April 2017

This NICE quality standard consultation (QS10031) is now available for review and comment. Closing date 16 May 2017.

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MHRA warning regarding hyoscine butylbromide

7th April 2017

MHRA published a warning in February 2017 reminding health professionals about the risk of serious adverse effects with hyoscine butylbromide injection IV/IM in patients with underlying cardiac disease. This followed a recent fatality (myocardial infarction) and a subsequent recommendation from the coroner to clarify the cautions section in SPC. The MHRA stated that they had received 9 reports of patients who had died following receiving hyoscine butylbromide injection and published the following advice:

• hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis
• these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension
• hyoscine butylbromide injection should be used with caution in patients with cardiac disease
• monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use this equipment, are readily available
• hyoscine butylbromide injection remains contraindicated in patients with tachycardia.

Subsequently, the MHRA have reviewed their data and have corrected the total number of fatal outcomes attributable to hyoscine butylbromide to 8 (see clarification on the MHRA Drug safety update website 3 April 2017). However, the episodes lacked full data and it is difficult to interpret the specific relevance of the reports to use in a palliative care setting, where the CSCI route of administration is more likely than IV. PCF advises clinicians to remind themselves of the longstanding cautions relating to the use of any antimuscarinic in patients with cardiovascular disease, and to continue to balance the potential for benefit and harm on an individual patient basis.

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Acetylcysteine oral powder launched in UK

7th April 2017

A new oral acetylcysteine powder is now available in the UK, authorized as a mucolytic adjuvant for respiratory disorders associated with thick, viscous, mucus hypersecretion. The dose is 200mg (1 sachet, dissolved in a little water) three times a day. The cost for 28 days@ 1 sachet t.d.s. = £315.

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