Prescriber Update - Medsafe

1 ISSN 1172-5648. Prescriber Update Vol. 31 No. 2. June 2010. Dextropropoxyphene withdrawal on 1 August 2010 a reminder 11. Methylphenidate updated guidance when treating children 11. Cough and cold medicines Update and reminder 12. Tramadol key points for prescribing 12. Omeprazole and risk of hypomagnesaemia 13. Update on rotavirus vaccines 14. Interaction: Sodium valproate and carbapenems new information 14. Case report: Stevens-Johnson syndrome associated with the use of allopurinol 14. Codeine classification and labelling changes 15. Adverse reactions associated with intra-articular use of local anaesthetics 15. Acitretin (Neotigason) points to remember 16. Warfarin reports of serious adverse reactions continue 16. Zoledronic acid associated with adverse effects on renal function 17.

2 Medicine recalls 17. Alendronate case report the importance of patient counselling 18. Medicine quality complaints 18. Intensive Medicines Monitoring Programme (IMMP) 19. A publication of NEW Z EALAND MEDI CI NES. AND MEDI CAL DEV I CES. SAF ETY AU THOR I TY Prescriber Update is a A BU SINESS U NIT OF member of the THE MINISTRY OF HEA LTH. w . Dextropropoxyphene withdrawal on unapproved medicines in New Zealand is available 1 August 2010 a reminder from the Medsafe website at: nz/profs/ Healthcare professionals are reminded that the consent to distribute dextropropoxyphene A copy of Medsafe 's risk:benefit review of containing medicines (Capadex and Paradex) dextropropoxyphene and a Question and Answer will be revoked on 1 August 2010. From this document is available at: date it will no longer be legal to sell, distribute or advertise these medicines unless exempted under the Medicines Act References 1.

3 M e d s a f e . D H C P L d a t e d 2 6 M a r c h 2 0 1 0 . Av a i l a b l e This decision follows a review by the Medicines a t : w w w. m e d s a f e . g o v t . n z / h o t / m e d i a / 2 0 1 0 /. Adverse Reactions Committee (MARC), which concluded that the risks of these medicines 2. MARC minute item for dextropropoxyphene, December outweigh their 2009. Available at: # Medsafe advises prescribers not to start any new 3. bpacNZ. 2010. Dextropropoxyphene containing medicines to patients on Capadex or Paradex. Patients currently be withdrawn. Best Practice Journal. 26: 44. taking these medicines should be reviewed at the earliest opportunity. Methylphenidate updated guidance The Best Practice Advocacy Centre (bpac NZ ) when treating children has recently issued the following advice for The MARC has reviewed recent changes to the transferring patients from dextropropoxyphene3: European product information for methylphenidate Most patients can be transferred to full doses and has recommended that the New Zealand data of paracetamol alone.

4 If pain relief is not sheets be updated to include these changes. The sufficient, the next step is to add a weak opioid updated data sheets will shortly be published on such as codeine (or use a combined paracetamol/ the Medsafe website at: codeine preparation). Alternatively, codeine profs/ alone could be trialed. The changes outline that patients being considered Oxycodone should not be prescribed in place for methylphenidate treatment should be carefully of dextropropoxyphene unless there has been screened for cardiovascular risk, heart disease an inadequate response to a weak opioid. and psychiatric disorders, including any family Oxycodone is a strong opioid and is only risk factors. indicated as an alternative to morphine on step New contraindications (do not use in patients three on the WHO analgesic ladder.)

5 With) include: As dextrpropoxyphene is a weak opioid it is Diagnosis or history of severe depression, possible that some patients may experience a anorexic disorders, suicidal tendencies, withdrawal reaction upon abruptly stopping psychotic symptoms, severe mood disorders, treatment. Should a patient experience a severe mania, schizophrenia, psychopathic/borderline withdrawal reaction advice may be sought from a personality disorder. local alcohol and drug dependency service. Pre-existing cardiovascular disorders. Further advice about transferring patients from dextropropoxyphene is planned in the next edition Pre-existing cerebrovascular disorders. of Best Practice Journal. Patients for whom methylphenidate treatment is From 1 August 2010 Capadex and Paradex can deemed appropriate should be carefully monitored only be legally supplied in New Zealand under the as follows: provisions in the Medicines Act 1981 that relate Blood pressure should be recorded at every to the supply of unapproved medicines (sections dose adjustment and then at least every six 25 and 29).

6 Further information on the use of months; pulse should also be recorded. 11 Prescriber Update 2010; 31(2) June Height, weight and appetite should be recorded In addition medicines containing bromhexine, at least every six months. Patients who are not oxymetazoline and xylometazoline should not be gaining height or weight as expected may need used in children under two years of age. a treatment break. Due to the long lead times between products Patients who develop symptoms suggestive of being manufactured and their retail availability, heart disease should undergo prompt specialist medicines with updated package labelling may not cardiac evaluation. start to appear until later this year. The deadline for updated package labelling is May 2011. Although Prescribers and pharmacists should look out the gradual change in product labelling may cause for signs of diversion, misuse and abuse of some confusion, Medsafe considers this is the best methylphenidate.

7 Way to ensure these products remain available for Methylphenidate can cause or worsen some adults over the coming winter season. psychiatric disorders such as depression, suicidal In its review, the Cough and Cold Review Group thoughts, hostility, anxiety, agitation, psychosis also recommended that children with colds should and mania. Psychiatric well being should therefore be allowed to rest, be made comfortable and be be monitored in patients being treated with given plenty of fluids. In some cases it may be methylphenidate. appropriate to use saline nose drops, or to give Further information on monitoring the psychiatric honey drinks to children over one year of age to well being of young people is available in a special help soothe a cough. edition of the Best Practice Journal published in The Medicines Classification Committee (MCC).

8 January 2010 ( recently reviewed a submission to reclassify ). This medicines containing dextromethorphan, information is also included in the Ministry of guaiphenesin, ipecacuanha and phenylephrine, Health's funded module of bpac's decision support indicated for the treatment of the symptoms of the software. common cold. The outcome of the Committee's It is also important to remember that the long-term review will be published separately. effects of methylphenidate treatment in children are not fully understood. For patients who require long-term treatment (more than 12 months) the data Tramadol key points for prescribing sheets will recommend that a treatment holiday Tramadol will be fully funded in New Zealand for occur at least once a year. A treatment holiday will the first time from 1 June 2010.

9 Medsafe wishes help determine whether methylphenidate treatment to take this opportunity to provide a summary of needs to be continued. key points for prescribers who are considering treatment with tramadol. Cough and cold medicines Update and Prescribers are encouraged to familiarise themselves reminder with the complete prescribing information for tramadol available on the Medsafe website at: With winter approaching, healthcare professionals are reminded that medicines intended for the asp treatment of the symptoms of the common cold should not be used in children under six years of Tramadol is a synthetic opioid analgesic indicated age if they contain one or more of the following for the treatment of moderate to severe pain at substances: step 2 of the WHO analgesic ladder.

10 Importantly tramadol inhibits the reuptake of serotonin and guaifenesin phenylephrine doxylamine noradrenaline in addition to its opioid action. ipecacuanha brompheniramine promethazine The maximum daily dose of tramadol should not dextromethorphan chlorphenamine triprolidine exceed 400 mg per day; however the elderly (over 75 years of age) and those with renal or hepatic pholcodine diphenhydramine pseudoephedrine impairment usually require lower doses. Prescriber Update 2010; 31(2) June 12. Tramadol should not be used in patients: Omeprazole and risk of With acute intoxication with alcohol, hypnotics, hypomagnesaemia analgesics, opioids or psychotropic medicinal Healthcare professionals are advised that an products. association between omeprazole treatment and Who are receiving monoamine oxidase hypomagnesaemia has been identified.