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BUNAVAIL (buprenorphine and naloxone) buccal film is a citrus flavored oral transmucosal form of buprenorphine, an opioid partial agonist, and naloxone, an opioid antagonist, intended for application to the buccal mucosa. Each dose unit is a yellow rectangular film, with ink marking on the mucoadhesive side.
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid (narcotic) dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist–antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids.
Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
How to use Bunavail Film, Medicated
Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Use this medication as directed by your doctor, usually once daily. Before using, rinse your mouth with water or use your tongue to wet the inside of your cheek. Use the tip of a dry finger to place one film inside your mouth with the text side facing against one cheek. Press and hold the film in place for 5 seconds, then remove your finger. The film should stay in place on its own after this. Leave it in place until it is dissolved. Do not move the strip with your tongue/finger or drink or eat food until the film has completely dissolved. If your doctor directs you to use more than one film at the same time, do not place one on top of the other. Place one film on each side of your mouth.
Do not cut, tear, chew, or swallow the film. Doing so will make this medication work less well. Do not inject (“shoot up“) buprenorphine/naloxone. Injecting it is dangerous, and will likely cause severe withdrawal symptoms due to the naloxone in this medication, especially if you have been using opioids such as heroin, morphine, or methadone.
Buprenorphine alone may be used instead of this medication for the first 2 days after you have stopped all other opioids. It is usually given in your doctor’s office. Your doctor will then switch you to this combination buprenorphine/naloxone medication for maintenance treatment. Do not change forms of this medication without your doctor’s instructions.
The dosage is based on your medical condition and response to treatment. Your doctor will adjust the dose until there are no symptoms of withdrawal. Do not switch between sublingual tablets/film or buccal film, because you may need a different dose if you switch. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop the medication when directed.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as diarrhea, restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get medical help right away
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this medication include: naltrexone, certain pain medications (mixed opioid agonist–antagonists such as butorphanol, nalbuphine, pentazocine).
Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), including amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, among others.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Tell your doctor or pharmacist if you are taking other products such as alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, hydrocodone).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Some people have died when they misused this medication by injecting it (“shooting up”), especially if they used it in combination with benzodiazepines (such as diazepam) or other depressants such as alcohol or additional opioids.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.
Do not share this medication with others. Sharing it is against the law.
Tell all of your doctors that you use this medication and have regularly used opioids, especially if you are getting emergency treatment.
Laboratory and/or medical tests (such as liver function tests, urine drug screening) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store in a secure place at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Read the Medication Guide for details. In the US, the FDA recommends flushing this medication down the toilet. Consult your pharmacist or local waste disposal company.Information last revised March 2018.
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
BUNAVAIL contains buprenorphine, a Schedule III controlled substance that can be abused in a
manner similar to other opioids, legal or illicit. Prescribe and dispense buprenorphine with
appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate
protection from theft, including in the home. Clinical monitoring appropriate to the patient’s
level of stability is essential. Multiple refills should not be prescribed early in treatment or
without appropriate patient follow-up visits [see Drug Abuse and Dependence (9.2)].
5.2 Risk of Respiratory and Central Nervous System (CNS) Depression
Buprenorphine has been associated with life-threatening respiratory depression and death.
Many, but not all, post-marketing reports regarding coma and death involved misuse by selfinjection
or were associated with the concomitant use of buprenorphine and benzodiazepines or
other CNS depressants including alcohol. Warn patients of the potential danger of selfadministration
of benzodiazepines or other CNS depressants while under treatment withBUNAVAIL
Use BUNAVAIL with caution in patients with compromised respiratory function (e.g., chronic
obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia,
hypercapnia, or pre-existing respiratory depression).
5.3 Managing Risks from Concomitant Use of Benzodiazepines or Other
Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the
risk of adverse reactions including overdose and death. Medication-assisted treatment of opioid
use disorder, however, should not be categorically denied to patients taking these drugs.
Prohibiting or creating barriers to treatment can pose an even greater risk of morbidity and
mortality due to the opioid use disorder alone.
As a routine part of orientation to buprenorphine treatment, educate patients about the risks of
concomitant use of benzodiazepines, sedatives, opioid analgesics, and alcohol.
Develop strategies to manage use of prescribed or illicit benzodiazepines or other CNS
depressants at initiation of buprenorphine treatment, or if it emerges as a concern during
treatment. Adjustments to induction procedures and additional monitoring may be required.
There is no evidence to support dose limitations or arbitrary caps of buprenorphine as a strategy
to address benzodiazepine use in buprenorphine-treated patients. However, if a patient is sedated
at the time of buprenorphine dosing, delay or omit the buprenorphine dose if appropriate.
Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant
use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others,
gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or
decreasing to the lowest effective dose may be appropriate.
For patients in buprenorphine treatment, benzodiazepines are not the treatment of choice for
anxiety or insomnia. Before co-prescribing benzodiazepines, ensure that patients are
appropriately diagnosed and consider alternative medications and non-pharmacologic treatments
to address anxiety or insomnia. Ensure that other healthcare providers prescribing
benzodiazepines or other CNS depressants are aware of the patient’s buprenorphine treatment
and coordinate care to minimize the risks associated with concomitant use.
In addition, take measures to confirm that patients are taking their medications as prescribed and
are not diverting or supplementing with illicit drugs. Toxicology screening should test for
prescribed and illicit benzodiazepines [see Drug Interactions (7)].
5.4 Unintentional Pediatric Exposure
Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are
accidentally exposed to it. Store buprenorphine-containing medications safely out of the sight
and reach of children and destroy any unused medication appropriately
5.5 Neonatal Opioid Withdrawal Syndrome
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 [see Use in Specific Populations.
Advise pregnant women receiving opioid addiction treatment with BUNAVAIL of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Use in Specific Populations. This risk must be balanced against the risk of untreated
opioid addiction which often results in continued or relapsing illicit opioid use and is associated
with poor pregnancy outcomes. Therefore, prescribers should discuss the importance and
benefits of management of opioid addiction throughout pregnancy.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Risk of Opioid Withdrawal with Abrupt Discontinuation
Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset. When discontinuing BUNAVAIL, gradually taper the dosage.
Nausea, vomiting, drowsiness, dizziness, constipation, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
- To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
- To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
- Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Although this medication is used to prevent withdrawal reactions, it may rarely cause opioid withdrawal symptoms (see also How to Use section). This is more likely to happen when you first start treatment or if you have been using long-acting opioids such as methadone. If such symptoms occur, tell your doctor or pharmacist right away.
Severe (possibly fatal) breathing problems can occur, especially if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other opioids).
- Tell your doctor right away if you have any serious side effects, including: signs of your adrenal glands not working well (such as unusual tiredness, weight loss).
- Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, severe dizziness, mental/mood changes (such as agitation, confusion, hallucinations), slow/shallow breathing, unusual drowsiness/difficulty waking up.
- This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
- A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages and list of side effects as well as information on the drug. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
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