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8 mg Ensure clinical review to monitor patient + + 8 mg 8 mg 8 mg Ensure clinical review to monitor patient
ADVERTORIAL
TREATING CODEINE DEPENDENCE WITH
SUBOXONE ® ( buprenorphine hydrochloride / naloxone hydrochloride dihydrate )
SUBLINGUAL FILM 1
From February 2018 , all codeine-containing medicines will be restricted to prescription only . 2 This change could impact a variety of your patients , but for some , the new restrictions may be more serious – potentially revealing undiagnosed codeine dependence .
Codeine dependence is a serious medical condition that can happen to anyone . 3 Dependence can appear in patients you wouldn ’ t necessarily associate with opioid addiction . For example , one study showed that the most likely patients to become codeine dependent were employed females who were only using one pharmaceutical opioid . 4
A combination of patient interviews , observed behaviours and the presence of the physical signs of dependence ( including withdrawal ) can help identify your at-risk patients . 5 Some clinical observations that should be seen as ‘ red flags ’ include : 6
• Reluctance to use other methods of pain management
• Anxiety
• Euphoria
• Depression
• Gastrointestinal symptoms
• Sleep disorders
• Physical signs of acute withdrawal
• Faking or exaggerating symptoms to gain a prescription 7
Despite these ‘ red flags ’, dependence can be hard to identify . The Drug Abuse Screening Test ( DAST-10 ) is a simple screening tool that can help . It consists of 10 ‘ yes ’ or ‘ no ’ questions assessing drug use ( excluding alcohol and tobacco ) over the past 12 months . 8 If your patient answers ‘ yes ’ to any of the questions ( or ‘ no ’ for question 3 ) on the DAST-10 , they may need to be assessed for codeine dependence . 8
The DAST-10 can be accessed at www . drugabuse . gov / sites / default / files / dast-10 . pdf
If you have determined a patient is experiencing codeine dependence , there are a range of treatment options available . According to the World Health Organization , opioid agonist maintenance treatment will result in better outcomes than attempts at withdrawal . 9 One such maintenance treatment is SUBOXONE Sublingual Film ( buprenorphine / naloxone ). With a strong evidence base in heroin users , SUBOXONE Film was also demonstrated to be well tolerated in codeine-dependent patients , with comparable dose ranges to standard doses recommended in national guidelines . 10
TREATMENT WITH SUBOXONE FILM
SUBOXONE Film is a combination of the active ingredients buprenorphine and naloxone , and is indicated for the treatment of opioid dependence within a framework of medical , social and psychological treatment . 1 Buprenorphine is a partial opioid agonist with a high affinity for the μ-opioid receptor , which can reduce or block the effects of subsequently administered opioids . 11-13 At a dose of 16 mg , there is a 75 – 95 % reduction in μ-opioid receptor availability . 14
The benefits of SUBOXONE include a low risk of overdose during induction , the ability to rapidly increase the dose to stabilise a patient on treatment and a lower likelihood of sedation compared with full opioid agonist treatment . 9
The initial aim of treatment is to reach an effective / therapeutic dose
Induction example :
INDUCTION DAY 1
INDUCTION DAY 2
INDUCTION DAY 3
STABILISATION DAY 4 – 7 as soon as possible ( i . e . the patient no longer experiences cravings or withdrawal symptoms ), this is referred to as induction . 11 Following induction is stabilisation , where the dose is ‘ fine-tuned ’ to obtain and maintain the most effective dose for the patient . Most patients will be stabilised on 12 – 24 mg of SUBOXONE Film , with the maximum recommended daily dose following induction 32 mg / day . Buprenorphine causes less respiratory depression than full opioid agonists ; however , caution is required , particularly when used in combination with benzodiazepines . 1 , 11
An example of induction dosing is shown in the figure below . It is important to note that patients must be presenting with objective signs of opioid withdrawal – the COWS scale is a useful tool to guide assessment of withdrawal symptoms . 11
The COWS scale can be found at www . drugabuse . gov / sites / default / files / files / ClinicalOpiateWithdrawalScale . pdf
Adapted from Gowing L , et al . 2014 . 11 * This ‘ split dosing ’ reduces the risk of a precipitated withdrawal . If ‘ split dosing ’ may be required , contact the nominated pharmacy to make this arrangement . 11
†
Adequate stabilisation dose is when the patient no longer experiences withdrawals and cravings for codeine or other opioids . In the maintenance period , ongoing review and optimisation of medication dosing regimens should consider continued drug use , medication effects , side effects , patient reports of dose adequacy and treatment goals . 11
Until clinically stabilised , most patients should be reviewed at least once a month . More frequent reviews should occur early in treatment or during periods of instability and withdrawal attempts . 11
In the first week of treatment , regular contact with the patient is highly recommended to ensure that the appropriate dosing can be determined . This can then be communicated to the authorised dispensing site . Once on a stable dose and doing well , the patient can be seen less frequently for prescriptions .
However , other aspects of psychosocial assessment may be needed more frequently .
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2 mg 2 mg 2 mg 2 mg Start with one 4 mg dose , with a possible additional 4 mg dose 1 – 2 hours apart depending on the individual patient ’ s requirements * 11
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8 mg
8 mg Ensure clinical review to monitor patient + + 8 mg 8 mg 8 mg Ensure clinical review to monitor patient
Optimal doses are typically in the range of 12 – 24 mg / day to :
• Stop withdrawal symptoms
• Reduce / block opiate cravings
• Obtain adequate exposure over the dosing period ( i . e . avoiding pre-dosing withdrawal symptoms ). 15
Up to 8 mg
Increase the dose by 2 , 4 or 8 mg 11
Up to 16 mg
Increase the dose by 2 , 4 or 8 mg 11
Up to 24 mg
Increase the dose by 2 , 4 or 8 mg 11
Up to 32 mg
Following stabilisation of symptoms , patients should receive maintenance treatment †
An excellent resource for patients experiencing , or who know someone experiencing , codeine dependence is the Turn To Help website , available at www . turntohelp . com . au
If you would like more information about SUBOXONE Film , please contact your local clinical liaison . For general enquiries contact : General-AU-Enquiries @ indivior . com . For adverse events , product complaints or medical enquiries contact : patientsafetyROW @ indivior . com
This advertorial is brought to you by Indivior .
PBS Information : This product is listed on the PBS as a Section 100 Opiate Dependence Item . Refer to PBS Schedule for full authority information .
Please review full Product Information before prescribing . Full Product Information is available at www . tga . gov . au / hp / information-medicines-pi . htm
MINIMUM PRODUCT INFORMATION : Suboxone ® Sublingual Buprenorphine ( as hydrochloride ) + naloxone ( as hydrochloride dihydrate ). Indication : Treatment of opioid dependence within a framework of medical , social and psychological treatment . Contraindications : Hypersensitivity to ingredients ; children less than 16 years ; severe respiratory or hepatic insufficiency ; acute intoxication with alcohol or other CNS depressants ; pregnancy ; breastfeeding . Precautions : Elderly or debilitated ; hepatic , respiratory or renal impairment ; hypothyroidism ; adrenal cortical insufficiency ; hypotension ; prostatic hypertrophy , urethral stenosis ; increased intracholedochal pressure ; kyphoscoliosis ; head injury or increased cerebrospinal pressure ; CNS depression ; toxic psychoses ; delirium tremens ; acute alcoholism ; hepatitis ; driving or operating machinery ; misuse , abuse or diversion ; respiratory depression ; allergic reaction , use in opioid-naïve patients . May obscure diagnosis or clinical course of patients with acute abdominal conditions . Administration too soon after another opioid may cause withdrawal syndrome in opioid dependent patients . For details , see full Product Information . Interactions : Alcohol ; benzodiazepines ; other CNS depressants ; other opioid analgesics ; naltrexone ; CYP3A4 inhibitors or inducers . Adverse effects : Common : upper respiratory tract infection , vomiting , sinusitis , pharyngitis streptococcal , urinary tract infection , influenza , tooth abscess , glossodynia , hypoaesthesia oral , nausea , oral mucosal erythema , toothache , back pain , arthralgia , musculoskeletal pain , insomnia , stress , skin laceration , pain , headache , nephrolithiasis , dermatitis contact , rash , stomatitis . For adverse events relating to Suboxone ® Tablets or buprenorphine alone or observed during post-marketing surveillance see full Product Information . Dosage and administration : Place under the tongue until dissolved . Avoid overlapping if taking more than one . Avoid food , drinks , chewing , swallowing or moving film until completely dissolved . Not designed to be split or broken . Induction a ) from short-acting opioids : start ≥ 6 hours after last opioid use or when early signs of withdrawal appear ; 4 mg on day 1 , with possible additional 4 mg depending on individual patient ’ s requirement . b ) from methadone : first reduce methadone dose to ≤ 30mg / day ; first dose of Suboxone ≥ 24 hours after last methadone dose ; start with 4mg when early signs of withdrawal appear . Dose adjustment and maintenance - increase dose progressively according to clinical effect up to 32 mg / day . Less than daily dosing - decrease to dosing every other day at twice the individually titrated daily dose , then to 3 times a week ; do not exceed 32mg / day Reducing and stopping : gradual dose taper over 21 days must be part of a comprehensive treatment plan . For more details on dosage and administration , see full Product Information . Indivior Pty Ltd , 78 Waterloo Road , Macquarie Park , NSW 2113 . Based on Product Information dated October 2017 .
References : 1 . Suboxone Sublingual Film Approved Product Information , October 2017 . 2 . Therapeutic Goods Administration ; Codeine Information Hub . Available at : https :// www . tga . gov . au / codeine-info-hub Accessed December 2017 . 3 . The TEDS Report , 2010 . 4 . Nielsen S , et al . Drug Alcohol Rev 2015 ; 34 ( 3 ): 304-11 . 5 . Substance Abuse and Mental Health Services Administration Centre for Substance Abuse Treatment . Clinical guidelines for the use of buprenorphine in the treatment of opioid addiction . TIP Series 40 , DHHS Publication ( SMA ) 04-3939 . 2004 . 6 . Kahan M , et al . Can Fam Physician . 2006 ; 52:1081 – 1087 . 7 . Kimergard A , et al . QJM 2017 ; 110 ( 9 ): 559 – 564 . 8 . Skinner HA , Addict Behav 1982 ; 7 ( 4 ): 363-371 . 9 . World Health Organization ; Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence . 2009 . 10 . Nielson S , et al . Drug Alcohol Rev 2016 ; 35:70-75 . 11 . Gowing L , et al . National Guidelines for Medication-Assisted Treatment of Opioid Dependence . Australian Government National Drug Strategy ; 2014 . 12 . Bell J et al . Addiction 2009 ; 104:1193 – 1200 . 13 . Luty J et al . BMJ 2005 ; 331:1352 – 3 . 14 . Law FD et al . Acta Neuropsychiatrica 2004 ; 16:246 – 74 . 15 . Greenwald MK , et al . Drug Alcohol Depend 2014 ; 144:1 – 11 .
Suboxone ® Sublingual Film is a registered trademark . Indivior Pty Ltd , ABN 22 169 280 102 . 78 Waterloo Road , Macquarie Park , NSW 2113 . SBF-AU-PRMO-1006-1709 . December 2017 . S & H INDSU0072