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Suboxone (Buprenorphine Hydrochloride / Naloxone Hydrochloride) - Summary

 
 



SUBOXONE SUMMARY

SUBOXONE (buprenorphine and naloxone) sublingual tablet is an an uncoated hexagonal orange tablet, imprinted with a sword logo on one side and an alphanumeric imprint identifying the product and strength. It contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases).

SUBOXONE sublingual tablet is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.


See all Suboxone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Suboxone (Buprenorphine / Naloxone)

Suboxone Maker Pulls Pills in Favor of Film
Source: MedPage Today Product Alert [2012.09.25]
The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough.

more news >>

Published Studies Related to Suboxone (Buprenorphine / Naloxone)

Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. [2013]
study... CONCLUSIONS: This research using 2 medications will demonstrate whether BUP,

A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. [2011.07.12]
Aims To provide controlled data on direct induction with buprenorphine/naloxone (BNX) versus indirect buprenorphine (BPN)-to-BNX induction. Design Phase 4, prospective, randomized, active-drug controlled, parallel-group trial consisting of a 2-day, double-blind, double-dummy induction phase followed by 26 days of open-label treatment with BNX...

Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. [2011.03]
A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency...

The subjective, reinforcing, and analgesic effects of oxycodone in patients with chronic, non-malignant pain who are maintained on sublingual buprenorphine/naloxone. [2011.01]
Some sources suggest that significant misuse of opioid drugs exists among patients with chronic pain. However, the risk factors and motivation behind their abuse may differ from those of other opioid abusers... These data suggest that sublingual Bup/Nx has the potential as an analgesic medication and further research should investigate its use in treating patients with chronic pain who abuse opioids.

Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. [2011]
A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency...

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Clinical Trials Related to Suboxone (Buprenorphine / Naloxone)

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603) [Completed]
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE« (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan [Completed]
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.

Preference for Subutex´┐Ż (Buprenorphine) Versus Suboxone´┐Ż (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex´┐Ż (Study P05094)(COMPLETED) [Completed]
This study is designed to determine if opioid dependent subjects who are already receiving Subutex« prefer the Suboxone« tablet over the Subutex« tablet after switching from Subutex« to Suboxone«. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex« (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone┬« (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex┬«.

Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population [Active, not recruiting]
The primary objective of this study is to compare overall patient preference for either Suboxone« sublingual film 8/2 or Zubsolv« sublingual tablets 5. 7/1. 4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5. 7 mg buprenorphine and 1. 4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.

Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444) [Completed]
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone« (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone« is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone«. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

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Reports of Suspected Suboxone (Buprenorphine / Naloxone) Side Effects

Maternal Exposure During Pregnancy (128)Drug Withdrawal Syndrome (101)Foetal Exposure During Pregnancy (97)Wrong Technique in Drug Usage Process (86)Convulsion (69)Substance Abuse (67)Underdose (58)Suicidal Ideation (57)Pain (54)Drug Withdrawal Syndrome Neonatal (49)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Suboxone has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Suboxone review by 28 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Opioid Addiction
Dosage & duration:   8mg/2mg taken once a day in the a.m. for the period of Continue to take it
Other conditions:   Depression, Anxiety
Other drugs taken:   Cymbalta, Neurontin
  
Reported Results
Benefits:   Suboxone is beneficial for two reasons: 1) It eliminated the opiate withdrawal when I was kicking my original drug of choice. 2) As a maintenance drug, Suboxone eliminates the cravings that I would normally have for opioids, as well as blocks the effects of agonist opioids (Heroin, Oxycodone, etc.) so that there is no temptation to take these drugs. Instead of struggling every day to avoid taking opioid drugs (and all of the terrible thing that come with being in active addiction) I can take Suboxone and move on with life. Suboxone may have quite literally saved my life.
Side effects:   My only major complaint is that since Suboxone is an opioid (though different from Heroin, Oxy, etc.) it causes constipation. Due to Suboxone's opioid blocking effect, if pain medication were needed in a hospital emergency setting, there could be complications. If I came in to the ER with a broken arm and they gave me a shot of Morphine, it would do absolutely nothing. Though this hasn't been an issue for me yet.
Comments:   I am a drug addict, and although I went to rehab to get off of opiate drugs I just couldn't seem to stop. So I went on Suboxone, which is a new alternative to Methadone treatment. While Methadone is a normal agonist opioid ('agonist' means it gets use high) it can be dispensed to drug addicts to keep them from withdrawing from their drug of choice because the Methadone lasts so long. But Methadone must be taken every day at a clinic and cannot be taken home, addicts can STILL use drugs while on Methadone if they choose too, it is EXTREMELY difficult to get off of, and Methadone still gets users high. Suboxone is a great alternative because it can be prescribed and bought at the pharmacy so you can take it at home, it takes care of your drug cravings but it doesn't get you high (not exactly, anyways, but it does satisfy the Opiate Receptors enough) and it's really not all THAT hard to get off of if you must (the withdrawals are are VERY manageable).

 

Suboxone review by 21 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Opiate/Heroin Addiction
Dosage & duration:   16mg / day. taken 2x daily - 8mg am, 8mg pm. for the period of 1.5 yrs to Present
Other conditions:   Depression
Other drugs taken:   Past- celexa. Present- Wellbutrin.
  
Reported Results
Benefits:   Was able to successfully, and completely, discontinue illicit use of heroin/opiates. I did remain abstinent for a period of time w/o it, but no longer than 6-7 months. Always at or before that point I would wind up relapsing again, with no good outcomes. Have stayed opiate-free for 1 year, 9 months now, and continue suboxone treatment.
Side effects:   Only negative(/side) effects noted are: Don't take doses too close together - feel dehydrated, headaches, fatigued. DO NOT neglect meeting w/prescribing physician for writing of next script. Ive had to miss 2+ appts before, and have gone b/t 1-6 days w/o medication. I HIGHLY SUGGEST TO AVOID THAT.
Comments:   I initially started at 4mg (/half 8mg tablet) 1x in am. Gradually rose to 1 8mg tablet 1x in am, and then 2 8mg tablets 1x in am. I found that, as said above, if i took doses too close together (ex: Noon on Sunday, then 4am Monday), would feel odd, off, and very drained. So now i take 1 8mg tab in am, and 1 8mg tab in pm. Found to be very effective and feel very 'steady' and 'even' throughout the day, and night. No issues with taking am/pm's too close together, or far apart. Also go to group & individual counseling, and see psychotherapist (as well as intermittent AA/NA meetings) to stay active in Recovery and stay healthy and well, all around. Also do the aforementioned to stay on top of depression and anxiety as well as reg life issues.

See all Suboxone reviews / ratings >>

Page last updated: 2014-11-30

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