Adverse events associated with the use of Suboxone and Subutex may include but are not limited to the following:. Subutex first received marketing approval in France and was launched in February by Schering-Plough under license from Reckitt Benckiser. Suboxone tablets have been studied in patients, Subutex tablets in patients and buprenorphine sublingual solutions in patients.
A total of females have received buprenorphine in clinical trials. Dosing recommendations are based on data from one trial of both tablet formulations and two trials of the ethanolic solution. All trials used buprenorphine in conjunction with psychosocial counseling as part of a comprehensive addiction treatment program.
There have been no clinical studies conducted to assess the efficacy of buprenorphine as the only component of treatment. At Recovery Care, we want our patients to be well-educated on every aspect of their care, especially when they opt for medication-assisted treatment. We know how it helps to support recovery in patients struggling with opioid addiction, and we know how Recovery Care applies Suboxone treatment in WV and PA as just one part of a comprehensive recovery plan which also includes counseling and recovery-based primary care.
What did our journey here look like? We want our patients to be well-educated on every aspect of their care, especially when they opt for medication-assisted treatment. The original medication that would eventually be developed into Suboxone and remains a major ingredient in Suboxone today is called buprenorphine. At this time in medical history, the unpleasant if not dangerous side-effects and addictive properties of morphine were already known. Buprenorphine was meant to provide patients with pain relief without putting them through additional struggles.
Buprenorphine itself took scientists two years of clinical testing to perfect, and they went through multiple failed attempts in the process. However, once they succeeded, the researchers who developed buprenorphine believed early on that their medication could also help those in treatment for narcotic addiction.
Also, these clinics commonly are located in or near urban centers, so patients in rural areas must drive long distances each day to obtain methadone. Finally, methadone abuse is increasing throughout the Northeast region, where abuse of heroin and other opiates is common, and increasingly is a factor in overdose deaths. On October 8, , FDA approved buprenorphine in two formulations, Subutex and Suboxone, for use in opiate addiction therapy. Subutex buprenorphine hydrochloride is used in the initial stages of therapy while Suboxone buprenorphine hydrochloride and naloxone hydrochloride is used in the maintenance stage.
Today, only these two formulations of buprenorphine meet DATA specifications; therefore, buprenorphine is the only drug that can be prescribed in a physician's office to treat opiate addiction.
A third, Buprenex, is marketed as a pain relief medication that cannot be used to treat opiate addiction. While most commonly used to treat addiction to heroin, buprenorphine can be used to treat addiction to any type of opiate, including oxycodones such as OxyContin and Percocet. Safeguards were put in place before buprenorphine was made available to the public because of widespread pharmaceutical diversion and increased prescription drug abuse in the nation.
In fact, Suboxone was designed specifically to meet FDA requirements for a more diversion-proof drug for use in opiate addiction therapy and is available only in the United States. The naloxone contained in Suboxone guards against abuse--if an abuser crushes and injects or snorts the Suboxone tablet, the naloxone in it precipitates withdrawal symptoms.
Naloxone Narcan reverses the effects of opiates. Further, in the Drug Enforcement Administration DEA reassessed the potential for abuse of, diversion of, and addiction to buprenorphine and rescheduled it from a Schedule V drug to a Schedule III drug, thus increasing the penalties for illegally obtaining, possessing, or abusing buprenorphine. To further safeguard buprenorphine from diversion, physicians prescribing the drug in either of the formulations approved for treating opiate addiction must become certified by attending a special training course and submitting their qualifications to the Substance Abuse and Mental Health Services Administration SAMHSA.
Physicians also must agree to refer patients for drug addiction counseling. The DEA-issued identification number assigned to each certified physician aids law enforcement and antidiversion officials in tracking any diversion of the drugs. Physicians prescribing buprenorphine therapy must maintain a log of all patients using Subutex and Suboxone and record the medication that has been prescribed to them.
FDA also has stipulated that the manufacturer of Subutex and Suboxone, Reckitt Benckiser Pharmaceuticals, must investigate any reports of diversion.
More than 1, physicians or group practices in the United States--over located in the Northeast--are certified to prescribe buprenorphine. Physicians currently are prohibited from prescribing Subutex and Suboxone to more than 30 patients at any given time.
The patient limit also applies to group practices. For example, a group practice of three certified physicians may prescribe Subutex and Suboxone to only 30 patients, not This legislation, if passed, will amend DATA by lifting the patient limit imposed on group practices and allowing each physician in a group practice to prescribe buprenorphine to 30 patients.
Buprenorphine is a derivative of thebaine, an extract of opium. The drug is an opioid synthetic opiate partial agonist and thus can produce the euphoria, analgesia, and sedation associated with opiates; however, while it stimulates the same brain receptors as full opiate agonists such as heroin and morphine, buprenorphine produces a lesser degree of sedation and respiratory depression than those drugs and causes no significant impairment of cognitive or motor skills.
Like methadone, buprenorphine reduces cravings for heroin and other opiates and reduces withdrawal symptoms, thus helping addicted individuals to stop abusing opiates. Also like methadone, buprenorphine blocks the effects of heroin by binding to the same opiate receptors as heroin; consequently, opiate addicts who use buprenorphine are not able to get a high from heroin.
Buprenorphine also has a "ceiling effect" whereby increased doses of the drug do not produce increased effects after a certain point, or ceiling. In fact, high doses of the drug can actually precipitate withdrawal symptoms in opiate addicted individuals. Because of this ceiling effect, buprenorphine is less susceptible to abuse than other opiates; however, because high doses of the drug can cause withdrawal symptoms, buprenorphine is not as effective as methadone in treating severely opiate-addicted individuals who require larger doses of opiates in order to maintain treatment therapy.
SAMHSA advises that the best candidates for buprenorphine therapy are those patients receiving 30 milligrams or less of methadone. Buprenorphine is estimated to be effective for approximately one-half to two-thirds of the opiate abuser population.
A New Form of Buprenorphine Administration. A new, extended-release formulation of buprenorphine, called a depot formulation, currently is being developed.
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