Glossary

This Glossary contains terms and abbreviations you may encounter on this website.

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Agonist:
A drug or medication that attaches to and activates specific receptors to stimulate drug actions or effects.

Full opioid agonist:
A drug or medication that stimulates activity at opioid receptors in the central nervous system that are normally stimulated by naturally occurring opioids. Examples of full opioid agonists include morphine, methadone, oxycodone, hydrocodone, heroin, codeine, meperidine, propoxyphene, and fentanyl.

Partial opioid agonist:
A drug or medication that stimulates activity at opioid receptors that does not produce the same maximal effects as a full opioid agonist. Like full opioid agonists this activity occurs at receptors that are normally stimulated by naturally occurring opioids. Under appropriate conditions, partial agonists can produce effects similar to either agonists or antagonists. Buprenorphine is a partial opioid agonist.

Antagonist:
A drug or medication that attaches to but does not activate specific receptors to stimulate drug actions or effects and can block other like drugs or medications from binding to a receptor (eg, an opioid receptor). Antagonists can also displace other drugs or medications. When an antagonist displaces an opioid, precipitate withdrawal can occur. Examples of opioid antagonists include naltrexone and naloxone.

Compulsive:
Behavior that is overpowering, repeated, and often irrational.

Craving:
The intense desire for a substance, also known as "psychological dependence."

Dependence:
As a general term, the state of needing or depending on something or someone for support or to function or survive. As applied to alcohol and other drugs, the term implies a need for repeated doses of the drug to feel good or to avoid feeling bad. In the DSM-IV, dependence is defined as "a cluster of cognitive, behavioral and physiologic symptoms that indicate a person has impaired control of psychoactive substance use and continues use of the substance despite adverse consequences." Feeling compelled to keep using a drug—even when you realize that you have a physical or psychological problem that is probably caused or made worse by the drug.

Dopamine:
A naturally occurring chemical that helps to cause feelings of pleasure in the brain. Opioid agonists stimulate dopamine activity.

Euphoria:
A feeling of pleasure, well-being, or of being "high."

Induction:
The first phase of medication-assisted treatment when medication (eg, buprenorphine) is given to ease a person's withdrawal symptoms. Induction usually lasts 2 to 3 days.

Maintenance:
The phase of treatment when the person is taking a stable dose and working with a physician or counselor to address other issues affecting his or her dependence and ability to rebuild his or her life.

Opioid dependence:
A chronic brain disease that involves a physical, psychological, and behavioral need for an opioid drug.

Opiate:
A drug created directly from opium or a naturally-occurring substance, such as a hormone, that has sedative or narcotic effects similar to those of opium. Morphine and codeine are examples of opiates.

Opioid:
A drug with opium-like qualities, which means it reduces pain, causes relaxation or sleepiness, and carries an addictive potential. Opioids can be derived from opiates or can be chemically related to opiates or opium, and include some prescription painkillers, such as oxycodone and hydrocodone. Buprenorphine, methadone, and heroin are opioids. Opioids include some prescription painkillers, such as oxycodone and hydrocodone.

Opioid receptors:
Specific places in the brain (central nervous system) or peripheral nervous system where molecules of opioid drugs or medications attach and start to exert their effect.

Overdose:
When a chemical substance is taken in quantities or concentrations that are large enough to overwhelm the body, causing life-threatening illness or death.

Physical dependence:
A state resulting from a habitual use of a drug where negative physical withdrawal symptoms result from abrupt discontinuation.

Precipitated withdrawal:
Withdrawal symptoms that result when one drug displaces another drug from the receptor, and the drug has no effect or less effect than the drug it displaced. When SUBOXONE is given before the patient is in mild-to-moderate withdrawal from the opioid he or she has already taken, it can cause withdrawal to occur more rapidly and intensely.

Psychological dependence:
A compulsion to use a substance or engage in a behavior that is psychologically, rather than physiologically, based.

Respiratory failure:
A person stops breathing.

Stigma:
Something that detracts from the character or reputation of a person or group; a symbol of disgrace.

Tolerance:
A decrease in response to a drug dose that occurs with continued use. Individuals who have become tolerant require more drugs or alcohol to achieve the same effects originally produced by lower doses.

Triggers:
Activities, sounds, places, people, images, events, or other things that may cause a dependent person to want to use drugs or alcohol again. Triggers can bring on cravings.

Withdrawal:
The uncomfortable symptoms (such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, cravings) that develop when a person stops taking a drug or medication on which he or she has become dependent.

SUBOXONE^® and Here to Help^® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
SUBOXONE Film is manufactured for Reckitt Benckiser Pharmaceuticals Inc.,
Richmond, VA 23235 by MonoSol Rx LLC, Warren, NJ 07059.
Copyright © 2011 Reckitt Benckiser Pharmaceuticals Inc.

Important Safety Information

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE^® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.

SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets. Dose reduction of CNS depressants, SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed during clinical trials and postmarketing experience for SUBOXONE Sublingual Tablets are headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and swelling of the limbs.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets. Please see full Product Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Glossary

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