Uses
What is buprenorphine/naloxone used for?
Buprenorphine/naloxone is commonly used to treat opioid use disorder. It can help you no longer feel the need to use opioids. Examples of opioids include prescription pain medicines like oxycodone and illicit drugs like heroin.
Buprenorphine/naloxone may also be used for other conditions as determined by your healthcare provider.
How does buprenorphine/naloxone work (mechanism of action)?
When dissolved in your mouth, buprenorphine works by partially activating the same receptors in your body that opioids do. This helps to ease withdrawal symptoms and cravings in people with opioid use disorder. Naloxone helps to prevent misuse of this medicine.
How is buprenorphine/naloxone supplied (dosage forms)?
Brands and other names
- Bunavail
- Cassipa
- Suboxone
Dosage forms and strengths
- 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, 12 mg/3 mg sublingual film
- 2 mg/0.5 mg, 8 mg/2 mg
How should I store buprenorphine/naloxone?
Buprenorphine/naloxone should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place in a secure location where other people cannot get to it.
Side Effects
What are the most common side effects of buprenorphine/naloxone?
The most common side effects of buprenorphine/naloxone are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Mouth numbness
- Redness or discomfort in your mouth
- Headache
- Nausea, vomiting
- Increased sweating
- Constipation
- Trouble sleeping
- Pain
- Swelling of your hands or feet
There may be other side effects of buprenorphine/naloxone that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of buprenorphine/naloxone?
While less common, the most serious side effects of buprenorphine/naloxone are described below, along with what to do if they happen.
Severe Allergic Reactions. Buprenorphine/naloxone may cause allergic reactions, which can be serious. Stop using buprenorphine/naloxone and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Central Nervous System (CNS) Depression. Buprenorphine/naloxone may slow down your central nervous system (CNS), which controls many vital functions throughout the body. Call your healthcare provider right away if you have any of the following symptoms of CNS depression.
- Confusion
- Excessive sleepiness or trouble staying awake
- Memory problems
- Slow or shallow breathing
- Slowed response or reaction time
- Slurred speech
Risk of Misuse and Addiction. Misuse means taking a medicine in a way other than how it was prescribed. Misusing buprenorphine/naloxone can lead to serious side effects like coma or death. Take buprenorphine/naloxone exactly as prescribed. Tell your healthcare provider if you feel that buprenorphine/naloxone is not working. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following serious symptoms.
- Sudden confusion or feeling disoriented
- Feeling paranoid
- Suicidal thoughts or actions
- Trouble breathing
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking buprenorphine/naloxone. Keep all appointments to have your blood checked. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Low Blood Pressure (Hypotension). Buprenorphine/naloxone may cause low blood pressure. If you feel faint or dizzy, lie down. Take your time standing up from a seated or lying position. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.
- Dizziness, feeling lightheaded, or fainting
- Confusion
- Feeling weak or tired
Reduced Adrenal Function. Buprenorphine/naloxone may cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.
- Nausea and vomiting
- Weakness, tiredness, or lack of energy
- Low blood pressure
Dental Issues. Buprenorphine/naloxone may cause problems with your teeth. Keep all appointments with your dentist. Call your healthcare provider if you notice any of the following symptoms.
- New or worsening cavities in your teeth
- Decay in your teeth
- Infection or abscess in your teeth or mouth
- Loss of existing fillings
- Broken or lost teeth
Warnings & Precautions
Who should not use buprenorphine/naloxone?
Allergies to Ingredients. People who are allergic to any of the following should not use buprenorphine/naloxone.
- Suboxone
- Buprenorphine
- Naloxone
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific buprenorphine/naloxone products they stock.
What should I know about buprenorphine/naloxone before using it?
Do not use buprenorphine/naloxone unless it has been prescribed to you by a healthcare provider. Use it as prescribed.
Do not share buprenorphine/naloxone with other people, even if they have the same condition as you. It may harm them.
Keep buprenorphine/naloxone out of the reach of children. Buprenorphine/naloxone is a controlled substance because it can be misused or lead to dependence. Store buprenorphine/naloxone in a safe place to protect it from theft. It is illegal to sell or give away this medicine.
Buprenorphine/naloxone is used by placing it under your tongue or against your cheek and allowing it to dissolve. Do not chew or swallow buprenorphine/naloxone until it fully dissolves in your mouth as doing so may cause the medicine to not work.
After your buprenorphine/naloxone has completely dissolved, you should rinse your mouth with water and then swallow it. You should wait at least one hour after taking buprenorphine/naloxone before brushing your teeth. This is an important method to help lower the chances that you develop potential dental problems from buprenorphine/naloxone.
Buprenorphine is a type of opioid and may cause serious breathing problems when combined with alcohol or other medicines that can cause sleepiness. Be sure to tell your healthcare provider of all medicines you are taking. See the Interactions section for more information.
People taking buprenorphine/naloxone should have naloxone available in the event of an emergency. Buprenorphine is a type of opioid and may cause a bad reaction where your breathing slows or potentially stops. Naloxone is a medicine used to reverse the effects of opioids. Your healthcare provider can show you and your loved ones how to use and where to get naloxone. If naloxone is used, be sure to call 911.
Buprenorphine/naloxone should only be used by dissolving it under your tongue or against your inner cheek. Do not cut, crush, chew or inject buprenorphine/naloxone.
Buprenorphine/naloxone can cause physical dependence, which means your body relies on the medicine. If you stop buprenorphine/naloxone suddenly, it could lead to withdrawal symptoms, which may require you to go to the hospital. Physical dependence is not necessarily a sign that you have developed a substance use disorder. Do not stop taking buprenorphine/naloxone without talking with your healthcare provider. Your healthcare provider can tell you how to stop buprenorphine/naloxone to reduce the risk of withdrawal reactions. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following serious symptoms.
- Sweating
- Shaking more than normal
- Feeling more hot or cold than normal
- Runny nose
- Watery eyes
- Goosebumps
- Vomiting, diarrhea
- Muscle aches
You should tell all of your healthcare providers that you are taking buprenorphine/naloxone. It is important for all of your healthcare providers to know this so that they can provide you with appropriate care.
Using buprenorphine/naloxone for a long time may reduce fertility in both women and men. Contact your healthcare provider if this is a concern for you.
Buprenorphine/naloxone can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how buprenorphine/naloxone affects you.
Do not adjust your dose of buprenorphine/naloxone on your own. If you feel that your current dose of buprenorphine/naloxone is not helping you, talk to your healthcare provider.
Buprenorphine/naloxone is commonly used to treat opioid use disorder. It works best when combined with counseling, behavioral therapy, and support. Keep all counseling appointments your healthcare provider recommends.
Buprenorphine/naloxone can be used for as long as you feel it is helping. If you want to stop taking buprenorphine/naloxone contact your healthcare provider.
You can dispose of any unused, unwanted or expired buprenorphine/naloxone by taking it to a local drug take-back site, or by removing it from its packaging and flushing it down the toilet.
Buprenorphine/naloxone may cause children to have serious breathing issues or potentially stop breathing if they take it, even by accident. Before taking buprenorphine/naloxone, tell your healthcare provider you are living with any children. Should your child take buprenorphine/naloxone, call 911 right away.
What should I tell my healthcare provider before using buprenorphine/naloxone?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if buprenorphine/naloxone is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Lung or breathing problems
- Addison's Disease
- Prostate problems or trouble urinating (peeing)
- Liver problems
- Kidney problems
- Gallbladder problems
- Alcohol use disorder
- Head injury or brain problems
- Mental health issues
- Problems with your adrenal gland
- Thyroid problems
- Dental problems
- Heart problems
- Stomach or abdominal problems
Other Medicines and Supplements. Buprenorphine/naloxone may interact with other medicines and supplements. Before taking buprenorphine/naloxone, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Taking buprenorphine/naloxone while pregnant may place your baby at risk of having opioid withdrawal, known as neonatal opioid withdrawal syndrome. This condition may be life threatening if not appropriately diagnosed and treated. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. Buprenorphine/naloxone can pass into breast milk and may harm your child. If you are taking buprenorphine/naloxone, talk with your healthcare provider about how to best feed your child.
Interactions
Does buprenorphine/naloxone interact with foods or drinks?
There are no known interactions between buprenorphine/naloxone and foods or drinks.
It is important to not take buprenorphine/naloxone with alcohol. The combination of buprenorphine/naloxone and alcohol may cause breathing problems that may be life-threatening.
Does buprenorphine/naloxone interact with other medicines (drug interactions)?
- A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
- A triptan, such as sumatriptan (Imitrex and others), eletriptan (Relpax), and others, which is a medicine commonly used to treat migraines
- A medicine used to treat depression or anxiety
- Other medicines that contain buprenorphine
- A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
- An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- An antipsychotic, which is a medicine for certain mental health conditions
- An opioid, such as prescription medicines like oxycodone, morphine, codeine, or fentanyl, which are used for certain types of pain, as well as illicit opioids like heroin.
- Any other medicine that causes dizziness and sleepiness, such as sleep medicines and muscle relaxants
- Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
- Atazanavir (Reyataz) or ritonavir (Norvir), which is a medicine commonly used to treat HIV
- Ketoconazole, which is a medicine used for fungal infections
- Carbamazepine (Tegretol, Carbatrol, and others), which is a medicine commonly used to treat seizures or nerve pain
- Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
- Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
Some other medicines may alter the blood levels of buprenorphine/naloxone. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with buprenorphine/naloxone. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much buprenorphine/naloxone?
If you or someone else has used too much buprenorphine/naloxone, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of buprenorphine/naloxone?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses unless instructed to by your healthcare provider.
Are you currently using Buprenorphine/Naloxone (Suboxone, Bunavail, and others)?
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