Drug dependence is a universal public health problem of which opioid dependence, notably involving heroin and morphine are a major component. In Europe alone, there are an estimated 1.1 million intravenous drug users and the number is estimated to be at least 3 times that many in North America. The majority of these individuals remain untreated.
Opioid dependence is a chronic relapsing medical condition that requires long-term treatment and patient support. In addition, many of these intravenous drug users share syringes and needles, a practice that can lead to the transmission of serious blood-borne infections including human immunodeficiency virus (HIV), hepatitis B and hepatitis C.
Currently opiate dependence treatments like methadone can be dispensed only in a few centers that focus in addiction treatment. There are not enough addiction treatment clinics to assist all patients seeking treatment. Suboxone is the first narcotic drug available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence that can be prescribed by a physician. Hopefully, this advance in therapeutics will provide more patients the opportunity to access treatment.
Suboxone (buprenorphine with naloxone) is currently available for the maintenance treatment of opioid addiction. The intention of adding naloxone to the formulation is to deter intravenous misuse and reduce the symptoms of opiate dependence. Suboxone treatment is intended for use in adults and adolescents more than 16 years of age who have agreed to be treated for addiction.
Once detoxification is completed, Suboxone is used during the maintenance phase of treatment. Suboxone has recently become the drug of choice instead of methadone in the treatment of opiate addiction. Suboxone use is less rigidly controlled than methadone because it has a lower potential for abuse and is less dangerous in an overdose. As patients progress on therapy, the physician may write a prescription for a take-home supply of the medication.
Only those physicians who have approval from the Drug Enforcement Agency (DEA) are able to start in-office treatment and provide prescriptions for ongoing medication. The Center for Substance Abuse Treatment (CSAT) maintains an active database to help patients locate qualified doctors.
Route of Administration
Suboxone is available as a tablet which is always administered sublingually. The pill is placed underneath the tongue until it is fully dissolved. Swallowing or sucking on the pill does not offer any therapeutic benefit. When placed underneath the tongue, the pill dissolves and is absorbed in 10 -20 minutes.
Suboxone treatment is generally done under medical supervision. During the induction phase, one is taught how to properly take the medications and dose adjustments are also done during this phase. One is usually started on the smallest dose until the best therapeutic effect is obtained. Once the ideal dose is obtained, the individual is seen once in a while and prescriptions can generally be available from the same physician.
Suboxone is available as 2 and 8 mg tablets. Most anecdotal reports indicate that the response to the 2 mg dose is suboptimal. The majority of individuals report benefit at higher doses of 8-16 mg. The aim of the maintenance treatment is to rid the drug craving and decrease the anxiety. The dose is usually adjusted until the drug craving features are diminished. Since Buprenorphine is a Schedule III drug, the physician is only allowed to prescribe 5 refills in 6 months.
Although Suboxone can be used for detoxification, its intended use is for maintenance. The ideal candidate for maintenance therapy with Suboxone is an older individual who has previously been on drugs but now has a job and wants a stable lifestyle. The individual previously has failed detoxification and wants to live a simple life without the daily cravings of his previous addiction. The majority of past drug users immediately adjust to Suboxone as the cravings disappear immediately and a smoother life style are accessible.
Because of the great potential for abuse, the FDA works closely with the drug manufacturer, Reckitt-Benckiser, and other agencies to develop an in-depth risk-management plan. The FDA receives quarterly reports from the manufacturer and pharmacies and maintains a comprehensive surveillance program. This monitoring allows for early detection of abuse of the drug. The major components of the risk-management program are preventive measures and surveillance. Preventive measures instituted include drug education, tailored distribution, Schedule III control under the Controlled Substances Act (CSA), child resistant packaging and supervised dose induction. The program regularly monitors local pharmacies and web sites. Numerous other agencies also monitor the abuse of Suboxone and these include:
- Drug Abuse Warning Network (DAWN). This agency run by the Substance Abuse and Mental Health Services Administration (SAMHSA) gathers data from emergency rooms related to the illicit use of drugs or non-medical use of a legal drug.
- Community Epidemiology Working Group (CEWG). This agency monitors the use of buprenorphine.
- National Institute of Drug Abuse (NIDA). NIDA frequently sends newsletters to physicians about the addictive drugs and to report it if necessary.
The most common reported side effect of Suboxone includes:
- Cold or flu-like symptoms
- Mood swings
Like other opioids, Suboxone have been associated with respiratory depression (difficulty breathing) especially when combined with other depressants.
Intravenous use of Suboxone usually in combination with benzodiazepines or other CNS depressants has been associated with significant respiratory depression and death. Suboxone has the potential for abuse and produces dependence of the opioid type with a milder withdrawal syndrome than full agonists. There are no adequate and well-controlled studies of Suboxone use in pregnancy. Due caution should be exercised when driving cars or operating machinery.
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