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 can produce increasing effects until the receptors are fully activated. Opioids with the greatest potential for abuse include full agonists such as oxycodone, hydrocodone, morphine, and heroin.

Partial Agonist:

An agonist that attaches to, and activates, a receptor, but not as much as a full agonist. However, it's possible for partial agonists to reduce the effects of full agonists by displacing or blocking them from the same receptors. Buprenorphine, the active ingredient in SUBOXONE Film, is a partial opioid agonist.

Antagonist:

A molecule that attaches to a cellular receptor without activating it.

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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 a substance, previously called as "psychological dependence."

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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

Indication

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

Important Safety Information

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

SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.

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

Your healthcare provider may monitor liver function before and during treatment.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Film, tell your healthcare provider if you are pregnant or plan to become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your healthcare provider immediately and you should report it using the contact information provided below. *

Opioid‐dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.

Before taking SUBOXONE Film, talk to your healthcare provider if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your healthcare provider should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

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

*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 prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE Film, SUBOXONE® (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.

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IMPORTANT SAFETY INFORMATION AND INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.