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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