Product Review: Generic Buprenorphine/Naloxone tablets

 

 

I’m thrilled to be able to present an in-depth review, compiled by one of my patients, of the generic forms of the buprenorphine/naloxone combination tablets. My patient thoughtfully composed this to help other people prescribed these products, and to share his own experience and opinion:

In active recovery it is extremely important to maintain a predictable and consistent titration of dosage in the slowest possible manner to reduce withdrawal. One patient has mostly eliminated the debilitating and relentless effects of withdrawal over a course of many years.

Years ago, this patient’s plan for recovery involved incredibly slow and methodical reduction of the suboxone tablets milligrams at a rate which would be monitored and progressively smaller. However, over the course of 2 years of slowly reducing the dosage, another factor came into play: that is the reported and vastly different half-life and strength in generic Suboxone.

At the beginning, this patient had been taking 2 of the 8mg tablets, or 16mg per day, for several months, after ending a habit which at its worst exceeded 120-140mg per day of OxyContin. Each year since ending any opiate pills, the suboxone was gradually reduced over the course of 12 years from 16mg per day to one-half of a 2mg/.5mg buprenorphine/naloxone tablet per day.

In August of 2018, Walgreens pharmacy reported to the patient that the Amneal NDC #65162-0416-03 became “unavailable for refill.” The reasons for this are unclear but it set into motion a series of trials of the several available 2mg/.5mg buprenorphine/naloxone tablets which resulted in the following analysis based on this patient’s experience:

NDC #65162-0416-03 is Amneal 2mg/.5mg buprenorphine/naloxone tablets. They are orange, small and compact with an “A” embossed on one side and a “14” on the other. Their price is about $8 per pill before insurance. Their taste is distinctive, not sweet nor bitter but a tolerable attempt most comparable to Saint Joseph’s baby aspirin, like a sweet and low version that is far less sweet. The half life is reported to be consistently close to 18 to 22 hours. The only real downside is that these little pills take an incredibly strong finger grip to manually break into a clean and even one-half pill. Even the most expensive pill cutter machines take great manual strength and accuracy to evenly break into halves without crumbs. This pill overall is an 8 on a ten scale largely due to its consistent half-life.

NDC #50383-0294-93 is from Akorn Inc. which produces a very low cost 2/.5mg buprenorphine/naloxone tablet, which are about $2 per pill. They are very small, white and come in a blister pack. They are so small and compact that it is all but impossible to cut in half. Their taste is bitterly distinctive and hardly tolerable as a sublingual. They taste as if the sublingual aspect was not considered at all. The half-life is reported to be consistently bad at no more than 6-8 hours at best. Strangely, these little pills are sometimes completely ineffective, and one wonders if there is any medicine at all in these pills. It would be disconcerting to think that these pills would be administered in a controlled, prison or public health environment as their bitter taste and ineffectiveness may lead one in recovery to compare this pill’s experience to one of all Suboxone pills and thereby keep one from seeking this type of maintenance. This pill is a 2 on a ten scale only because it might help one for a few hours.

NDC #00406-8005-03 is from SpecGX Inc. which produces a lower cost 2mg/.5mg buprenorphine/naloxone sublingual tablet which are about $3.50 per pill. They are smallish and orange and come shaped as a stop-sign. Their taste is also distinctive, not sweet nor bitter but very similar to the AMNEAL described above. Their taste is also a less sweet version of Saint Joseph’s baby aspirin. The half-life is reported to be less than AMNEAL version at only 10 to 12 hours, however. The same breakability issues pervade this orange pill as they are compact and hard to divide. This pill is a 5 on a ten scale only because it helps consistently but only for up to 10 hours.

NDC #00054-0188-13 is from Hikma 2mg/.5mg buprenorphine/naloxone tablets. They are a shade lighter orange, a bit larger than the other orange pills but with a “54/122” embossed on one side and blank on the other. Their price is about $5 per pill before insurance. Their taste is a bit less bitter than the others; however, still distinctive, and a tolerable orange taste. The half life is reported to be very consistent at 20 to 24 hours. They easily and manually break into a clean and even one-half pills without much crumbling at all. This pill overall is a 9 on a ten scale because it does what it is supposed to: be consistently manufactured to be predictably effective to keep withdrawal symptoms to a manageable minimum.

I hope my readers find this information useful. This is not a scientific evaluation but rather a patient’s rather extensive experience with generic buprenorphine/naloxone products. I am grateful to him for the time and trouble it took him to compile this.

 

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4 responses to this post.

  1. Posted by jessie on February 10, 2019 at 5:01 pm

    Do different formulations of buprenorphine really differ in their half-life? That seems strange. Obviously different formulations can vary in their average level of SL absorption, but once the bupe is in the systemic circulation and/or brain, why would some formulations be excreted more quickly?

    Reply

  2. Posted by Rebecca M Lowe on February 11, 2019 at 7:35 pm

    Hello Dr. Burson, please pass along a thank you to the client that wrote up his/her assessment of these medications. The information is invaluable. While it may seem that inability to evenly break the medications and pill crumbling are insignificant drawbacks, I know these irritants are not insignificant for a person trying to gradually titrate off these meds. Seems to me a pill scorer could be developed to get the job done. Even more so of importance is the effectiveness and duration of the medication. Thank you for all you do. Rebecca

    Reply

  3. Posted by lisa wheeler on February 12, 2019 at 7:26 pm

    This is excellent! Please thank you patient!

    Reply

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