About Buprenorphine Formulations

Tablets

Sublingual buprenorphine tablets: A generic version of the combination buprenorphine HCl with naloxone HCl dihydrate tablet, similar to the combination sublingual tablets formerly marketed as Suboxone, is available in 2 mg and 8 mg strengths, both in 30-count bottles. The 2 mg tablet can be cut to yield 0.5 mg doses; the 8 mg tablet can be cut to yield 2 mg doses for precise dosing.

A slightly different sublingual tablet formulation called Zubsolv® * has greater bioavailability and dissolves fast (within minutes).

The buprenorphine/naloxone combination tablet previously available as the brand Suboxone® is no longer produced, but the same name is now marketed as a sublingual film, described below.

Film

The buprenorphine/naloxone combination sublingual film (Suboxone®) is a tan/orange strip with a white logo printed on the back. They come in individually wrapped packets. The film adheres to moist oral mucosa. The film is placed at the base of the tongue to the side of midline. Thus two films can be used at the same time. Additional films are used after the first ones dissolve. Transitioning to the film from the tablet can be done without repeating the induction, but some patients may require a small change in dosage.

A buccal combinations film (place on the inside of the cheek) is marketed as Bunavail™. Product information describes that half a normal dose can achieve the same result as other products, due to twice the bioavailability. For example, BUNAVAIL 4.2 mg bup./0.7 mg nal.
buccal film provides equivalent buprenorphine exposure to the previously marketed SUBOXONE 8 mg bup./2 mg nal. sublingual tablet.

On Cutting the Film Formulation. Product information for the sublingual film (Suboxone®) (See external resources) directs prescribers to tell patients not to cut the films, however the PBM drug review (see related resources) describes cutting the film for dosage titration. There is cost savings in cutting the 8 mg film vs using a 2 mg film. Doses of less than 2 mg may be desired for incremental dose adjustment or for tapering from buprenorphine.

Doses Available
  • Suboxone sublingual film, , comes in 2 mg buprenorphine/0.5 mg naloxone, 4 mg buprenorphine/1 mg naloxone, 8 mg buprenorphine/2 mg naloxone, and 12 mg buprenorphine/3 mg naloxone doses.
  • The generic sublingual tablets come in 2 mg buprenorphine /0.5 mg naloxone and 8 mg buprenorphine/ 2 mg naloxone sizes.
  • Zubsolv® sublingual film comes in 1.4 mg buprenorphine/0.36 mg naloxone and 5.7 mg buprenorphine/1.4 mg naloxone
  • Bunavail™ buccal film comes in 2.1 mg bup./ 0.3 mg naloxone, 4.2 mg bup./ 0.7 mg naloxone, and 6.3 mg bup./ 1 mg naloxone

You may want to start by prescribing the 2 mg film or tablet to allow for small increment dose adjustment until the patient's maintenance dose is established.

*We are using brand names since there is a difference in the product that is not reflected in the generic name. We are not advocating one brand or the other.



Related Resources: 
Description: 
Find the links to each buprenorphine formulation's medication guide here
Source: 
FDA
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Patient Handout: Buprenorphine or Naloxone Combination-What Does It Mean for You?

Description: 
This patient handout explains buprenorphine, its makeup, and how it works to treat withdrawal.

Buprenorphine/Naloxone Combination Film or Tablets -- What do They Mean for You?


Your physician has prescribed buprenorphine/naloxone combination tablets (generic or Zubsolv®*) or film (Suboxone®) for you. There are a few things you should know before you begin taking it.


What is buprenorphine?
Buprenorphine is a type of drug called an opioid, similar to heroin, methadone or Oxycontin®. Taking buprenorphine will prevent you from going into withdrawal and should stop you from craving other opioids.


What is naloxone?
Naloxone counteracts opioids --including buprenorphine. If you take naloxone while you have an opioid in your system, or if you are dependent on opioids and find that you go into withdrawal without them, naloxone can trigger withdrawal.


That doesn't make sense --why would my doctor prescribe a drug which will send me into withdrawal?
Your buprenorphine/naloxone combination medication will not send you into withdrawal --provided you take them as your doctor prescribes!


If you dissolve the tablets or film under your tongue, or if you accidentally swallow one, the naloxone will not affect you --your body breaks the naloxone down too quickly for it to take effect! However, if you inject a combination tablet or film, the naloxone will take effect. You will probably not feel anything from the buprenorphine, and you could go into withdrawal.

 

 

 

How Taken Buprenorphine Naloxone What you feel
Under the tongue (as directed)
  • Works properly
  • Broken down by the body
  • No withdrawal; reduced craving
Swallowed (accidental)
  • Broken down by body
  • Medicine will not work; you could go into withdrawal or feel cravings
Injected (abuse)
  • Blocked by naloxone
  • Blocks effects of opioids
  • You could go into withdrawal very quickly

 

 

 

*We are using brand names since there is a difference in the product that is not reflected in the generic name. We are not advocating one brand or the other.

Tags:
Description: 
One-page handout that provides graphics and a description of the pharmacology of buprenorphine in layman's terms.
Source: 
The National Alliance of Advocates for Buprenorphine Treatment (NAABT)
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Description: 
Provides patients with an in-depth look at what to expect from buprenorphine treatment including preparing for treatment, urine testing, counseling, and effects on sleep and relationships.
Source: 
The National Alliance of Advocates for Buprenorphine Treatment (NAABT)
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