SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)

Glossary

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Learn more about the medical terms and abbreviations you may see on this website.

A

Abuse:

The misuse or overuse of anything.

Addiction:

A prolonged, uncontrollable need for a habit-forming substance that can cause physical symptoms upon withdrawal and the person continues use of the substance despite adverse consequences.

Agonist:

A molecule that attaches to, and activates, a cellular receptor.

Full Agonist:

An agonist that produces the maximum response possible when attached to a cellular receptor.

Partial Agonist:

An agonist that produces a lower response than a full agonist when attached to a cellular receptor. An important characteristic of partial agonists is that they can reduce the effects of full agonists. Buprenorphine, one of the two active ingredients in SUBOXONE Film, is a partial opioid agonist.

Antagonist:

A molecule that attaches to a cellular receptor and can block the effect of an agonist.

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C

Chronic condition:

A medical condition that persists over a long time, usually lasting longer than 3 months.

Compulsive:

An overwhelming, persistent impulse to perform a certain action.

Craving:

The intense desire for an object or experience (eg. drugs or alcohol).

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D

Dependence:

When the person stops taking a drug and withdrawal symptoms occur.

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I

Induction:

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

Intravenous:

Drug delivery through insertion of a needle into a vein.

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M

Maintenance:

The phase of treatment when the person is taking a stable dose and working with a healthcare provider or counselor to focus on other issues affecting his or her recovery.

Multi-dose:

Using or containing more than one dose.

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O

Opioid dependence:

A chronic medical condition affecting the brain that involves a physical, psychological, and behavioral need for an opioid drug.

Opiate:

A drug that contains opium or comes directly from it and has sedative or narotic effects similar to those of opium. Morphine and codeine are opiates.

Opioid:

A drug, also known as a narcotic, that comes from the opium plant, or can also be produced in a synthetic form. Opioids are prescribed to treat pain but also carry the potential for drug dependence. Opioids include some prescription painkillers, such as oxycodone and hydrocodone. Buprenorphine, methadone, and heroin are also opioids.

Overdose:

When a drug is taken in greater than normal or recommended quantities, which can cause serious, harmful symptoms or even death.

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P

Physical dependence:

The body's response when drug use is reduced or stopped, resulting in withdrawal signs and symptoms.

Psychological dependence:

A compulsion to use and keep using a substance despite harmful effects, and accompanied by a craving for its psychological effects.

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R

Rationalization:

Distorted thinking about one’s irrational behavior that makes it seem reasonable.

Relapse:

A setback after a time of improvement.

Respiratory failure:

When lungs stop functioning properly and they are unable to deliver enough oxygen to the blood or to clear carbon dioxide (a waste gas) from the blood. Organs such as the brain and heart need oxygen to work well.

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S

Stigma (social):

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

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T

Taper:

To gradually decrease.

Tolerance:

A decrease in response to a drug dose that occurs with continued use. For example, individuals who have become tolerant to opioids such as heroin or morphine require greater doses of these drugs to achieve the same effects originally produced by lower doses.

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U

Unit-dose packaging:

Packaging that contains individual doses to avoid medication error.

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W

Withdrawal:

The uncomfortable physical and psychological symptoms that develop when a person stops taking a drug or medication on which he or she has become dependent.

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Please see Full Prescribing Information and Medication Guide for SUBOXONE Film

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IMPORTANT SAFETY INFORMATION AND INDICATION

What is the most important information I should know about SUBOXONE Film?
Keep SUBOXONE Film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses SUBOXONE Film, get emergency help right away.

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SUBOXONE Film?

Keep SUBOXONE Film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses SUBOXONE Film, get emergency help right away.

SUBOXONE Film can cause serious and life‑threatening breathing problems. Call your healthcare provider right away or get emergency help if:

These can be signs of an overdose or other serious problems.

Do not switch from SUBOXONE Film to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of SUBOXONE Film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of SUBOXONE Film that may be different than other buprenorphine containing medicines you may have been taking.

SUBOXONE sublingual film contains an opioid that can cause physical dependence with chronic use.

Life‑threatening breathing problems, an overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using SUBOXONE Film. Ask your healthcare provider what you should do if you are taking one of these.

Call your healthcare provider or get emergency help right away if you:

Do not inject (“shoot‐up”) SUBOXONE Film.

In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBOXONE Film.

SUBOXONE film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your SUBOXONE sublingual film in a safe place to protect it from theft. Never give your SUBOXONE sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

Death has been reported in those who are not opioid dependent.

Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone, as serious negative effects, including anaphylactic shock, have been reported.

Do not take SUBOXONE Film before the effects of other opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have started to wear off as you may experience withdrawal symptoms.

SUBOXONE Film may not be right for you. Before taking SUBOXONE Film, tell your healthcare provider about all of your medical conditions, including:

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins and herbal supplements. SUBOXONE Film may affect the way other medicines work and other medicines may affect how SUBOXONE Film works. Some medicines may cause serious or life‑threatening medical problems when taken with SUBOXONE Film.

Sometimes the doses of certain medicines may need to be changed if used together. Do not take any medicine while using SUBOXONE Film until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are taking SUBOXONE Film.

Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines while using SUBOXONE Film until you have talked with your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

What should I avoid while taking SUBOXONE Film?

What are the possible side effects of SUBOXONE Film?

SUBOXONE Film can cause serious side effects, including:

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

To report pregnancy or side effects associated with taking SUBOXONE Film, please call 1‑877‑782‑6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

For more information about SUBOXONE Film, see the full Prescribing Information, and Medication Guide or talk to your healthcare provider. For REMS information visit www.suboxoneREMS.com.