Identifying the Pill with Imprint 54 411
The pill with the imprint "54 411" is a white, round tablet identified as Buprenorphine Hydrochloride, at a strength of 8 mg [1.2.1, 1.2.4]. It is manufactured by Hikma Pharmaceuticals USA Inc. [1.2.1, 1.2.3]. This medication is a generic formulation and is sometimes referred to by the discontinued brand name Subutex in non-clinical settings [1.2.3]. It is classified as a Schedule III controlled substance, indicating it has a moderate potential for abuse and may lead to physical or psychological dependence [1.2.1, 1.2.6].
What is Buprenorphine and How Does it Work?
Buprenorphine is an opioid medication used as a cornerstone of medication-assisted treatment (MAT) for Opioid Use Disorder (OUD) [1.3.1, 1.3.6]. It functions as a partial opioid agonist [1.3.1]. This means it binds to and activates the same mu-opioid receptors in the brain as full agonists like heroin or methadone, but to a much lesser degree [1.3.1, 1.3.2].
This unique mechanism of action allows buprenorphine to:
- Reduce Cravings: By occupying the opioid receptors, it diminishes the intense desire to use other opioids [1.3.1].
- Alleviate Withdrawal Symptoms: It prevents the severe physical and psychological discomfort that occurs when stopping other opioids [1.3.1, 1.3.7].
- Create a "Ceiling Effect": Unlike full agonists, the opioid effects of buprenorphine plateau at moderate doses. This means taking more of the drug does not increase the euphoric effects, which lowers the risk of misuse and fatal overdose from respiratory depression [1.3.1, 1.5.7].
Buprenorphine is also an antagonist at the kappa-opioid receptor, which may contribute to its therapeutic effects [1.3.6].
Primary Uses and Administration
The main indication for the 54 411 pill is the treatment of opioid dependence, both for induction (the initial phase of treatment) and maintenance [1.2.1, 1.3.6]. Treatment is most effective as part of a comprehensive plan that includes counseling and behavioral therapy [1.3.1]. In some cases, it may also be prescribed for chronic pain when other analgesics are insufficient [1.2.1, 1.2.7].
Proper administration is critical for the medication's effectiveness and safety:
- Sublingual Use: The tablet must be placed under the tongue to dissolve completely [1.3.6].
- Do Not Chew or Swallow: Chewing or swallowing the tablet reduces its effectiveness because buprenorphine is poorly absorbed through the digestive system [1.3.6, 1.4.2].
- Handling: Use dry hands to handle the tablet. If a dose requires more than one tablet, they should be placed under the tongue at the same time if possible [1.3.6].
- Post-Dose Care: After the tablet has dissolved, swish water around the mouth and swallow. To protect against dental problems like cavities and tooth loss, it is recommended to wait at least one hour before brushing your teeth [1.4.2, 1.4.3].
Potential Side Effects and Warnings
Like all medications, buprenorphine has potential side effects.
Common Side Effects:
- Headache [1.3.8, 1.4.1]
- Nausea and vomiting [1.3.8, 1.4.1]
- Constipation [1.3.8, 1.4.1]
- Insomnia (trouble sleeping) [1.3.8]
- Increased sweating [1.3.8]
- Dry mouth or mouth numbness [1.4.1, 1.4.3]
- Drowsiness and dizziness [1.4.1]
Serious Side Effects and Warnings:
- Respiratory Depression: The most significant risk is slowed or stopped breathing, which can be fatal. This risk is dramatically increased when buprenorphine is combined with other central nervous system (CNS) depressants like alcohol, benzodiazepines (e.g., Xanax, Valium), or other sedatives [1.3.6, 1.4.7].
- Addiction and Dependence: While used to treat addiction, buprenorphine itself can be habit-forming and lead to physical dependence. Sudden discontinuation can cause withdrawal symptoms [1.2.3, 1.3.2].
- Liver Problems: Buprenorphine can cause or worsen liver issues. Patients should have their liver function monitored by a doctor, especially if they have pre-existing conditions like hepatitis [1.3.3, 1.4.2].
- Dental Issues: The FDA has warned about serious dental problems, including cavities, infections, and tooth loss, associated with buprenorphine medicines that dissolve in the mouth [1.4.2, 1.4.4].
- Accidental Exposure: Keep the medication in a secure place where children and pets cannot access it. A single dose can be fatal to a child or someone who is not opioid-tolerant [1.3.6].
Comparison of Opioid Use Disorder Treatments
Buprenorphine is one of several medications used to treat OUD. It is often compared to methadone and naltrexone.
| Feature | Buprenorphine (54 411) | Methadone | Naltrexone |
|---|---|---|---|
| Mechanism of Action | Partial Opioid Agonist [1.3.1] | Full Opioid Agonist [1.5.1] | Opioid Antagonist [1.5.1] |
| Overdose Risk | Lower, due to "ceiling effect" [1.5.7] | Higher risk of respiratory depression [1.5.1] | No overdose risk from the drug itself; blocks opioid effects [1.5.1] |
| Dispensing Location | Can be prescribed by qualified physicians in an office setting [1.5.7] | Highly regulated; typically dispensed only at specialized opioid treatment programs (OTPs) [1.5.1] | Can be prescribed by any healthcare provider [1.5.1] |
| Initiation of Treatment | Must be in mild-to-moderate withdrawal to avoid precipitated withdrawal [1.5.5] | Can be started while opioids are still in the system. | Must be fully detoxed from opioids (7-10 days) to avoid precipitated withdrawal [1.5.1] |
| Treatment Retention | Studies show lower retention rates compared to methadone, though higher doses improve retention [1.5.5, 1.5.6] | Generally has higher treatment retention rates than buprenorphine [1.5.5, 1.5.6] | Can be difficult to start, which may affect retention [1.5.1] |
Conclusion
The pill imprinted with "54 411" is Buprenorphine Hydrochloride 8 mg, a critical medication in the management of opioid use disorder [1.2.1]. Its action as a partial opioid agonist helps reduce cravings and withdrawal symptoms, making it a safer alternative to full agonists due to its ceiling effect on respiratory depression [1.3.1, 1.5.7]. However, it is a controlled substance with risks of dependence, side effects, and dangerous interactions, particularly with CNS depressants [1.3.6]. Effective and safe use requires strict adherence to a doctor's prescription and administration guidelines, as part of a comprehensive treatment program that includes counseling and support [1.3.1].
For more information on treatment for opioid use disorder, a valuable resource is the Substance Abuse and Mental Health Services Administration (SAMHSA).
