This medication contains 2 medicines buprenorphine and naloxone. It is used to treat opioid 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, dissolved under the tongue, or dissolved on the inside of the cheek. 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
Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. This medication can either be dissolved under the tongue or dissolved on the inside of the cheek. Follow your doctor’s directions. Learn how to correctly use this medication. If you have any questions, ask your doctor or pharmacist.
Use this medication as directed by your doctor, usually once daily. Drink some water to moisten your mouth before use. This helps the film dissolve. With dry hands, open the foil packet just before use and place the medication film under your tongue or inside your cheek. Keep the film in place until it completely dissolves. Do not talk, swallow, chew, or move the film after placing it under your tongue or on the inside of your cheek, or it will not work as well.
If you are prescribed more than one film each day, place the second film under your tongue on the opposite side of the mouth or on the inside of the other cheek. Try not to have the films touch each other. If your doctor has prescribed a third film, place it under your tongue or on the inside of either cheek after the first 2 films have completely dissolved.
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.
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 and 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.
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 dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.
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).
Warnings & Precautions
Before taking this medication, tell your doctor or pharmacist if you are allergic to buprenorphine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).
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 (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other opioid pain relievers (such as codeine, hydrocodone).