What is Suboxone

Suboxone Film contains buprenorphine and naloxone. A complete treatment plan should include psychosocial support. Combining medications with psychosocial support can be beneficial for most
patients.

Buprenorphine Component:

  • Suboxone Film contains buprenorphine, a partial opioid agonist with a hight affinity for the mu-opioid receptor and lower intrinsic activity than full opioid agonists

    • Reduces subjective opioid cravings

Naloxone Component:

  • May attenuate the effects of buprenorphine if injected and precipitate withdrawal in individuals dependent on full opioid agonists

    • Although blood levels of the drug were measurable naloxone had no clinically significant effect when administered by the sublingual route because of low sublingual bioavailability

    • May help mitigate misuse or abuse by deterring intravenous use of the medication in individuals dependent on full opioid agonists

Pior to induction phase of opioid dependence treatment…

Consideration should be given to:

  • The type of opioid dependence (i.e., long- or short-acting opioid products)

  • The time since last opioid use

  • The degree or level of opioid dependence

Patient considerations

Patients dependent on methadone or long-acting opioid products

  • Buprenorphine monotherapy is recommended in patients taking long-acting opioids when used according to approved administration instructions

  • Following induction, the patient may then be transitioned to once-daily Suboxone Film

Patients dependent on heroin or other short-acting opioid products

  • Patients dependent on heroin or short-acting opioid products may be inducted with either Suboxone Film or with sublingual buprenorphine monotherapy

  • The first dose of Suboxone Film or buprenorphine should be administered when objective sings of moderate opioid withdrawal appear, and not less than 6 hours after the patient last used an opioid.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with
moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with
moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

References:

  1. National Institute on Drug Abuse. Drugs, brains, and behavior: the science of addiction. Revised August 2010. Bethesda, MD: 1-36.

  2. SUBOXONE Sublingual Film [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; April 2014.

  3. Huang P, Kehner GB, Cowan A, Liu-Chen L-Y. Comparison of pharmacological activities of buprenorphine and norbuprenorphine: norbuprenorphine Is a potent opioid agonist. J Pharm Exp Ther. 297:688–695, 2001.

  4. Fudala PJ, Bridge TP, Herbert S, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349(10):949-958.

  5. Ling W, Amass L, et al. A multi-center randomized trial of buprenorphine–naloxone versus clonidine for opioid detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network. Addiction. 2005 August;100(8):1090–1100.

  6. Fareed A, Vayalapalli S, et al. Heroin anticraving medications: a systematic review. Am J Drug Alcohol Abuse. 2010; 36:332-341.

  7. Harris DS, Jones RT, Welm S, Upton RA, Lin E, Mendelson J. Buprenorphine and naloxone co- administration in opiate-dependent patients stabilized on sublingual buprenorphine. Drug and Alcohol Dependence. 2000; 61: 85–94.

  8. Harris DS, Mendelson JE, Lin ET, Upton RA, Jones RT. Pharmacokinetics and subjective effects of sublingual buprenorphine, alone or in combination with naloxone. Clin Pharmacokinet. 2004;43 (5): 329- 340.

  9. Data on file. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.

  10. SUBOXONE Sublingual Film [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; April 2014.