Buprenorphine and Naloxone

💊 What is Buprenorphine and Naloxone used for?

• •The label says it is indicated for maintenance treatment of opioid dependence. The label says it should be used as part of a complete treatment plan that includes counseling and psychosocial support. The patient information describes it as used to treat opioid addiction in adults.

How it works

The label says buprenorphine is a partial agonist at the mu-opioid receptor, and naloxone is an opioid receptor antagonist. Together, the label describes the tablet as suppressing opioid withdrawal signs and symptoms and helping people stay in treatment.

How it is usually taken

• •The tablet is placed under the tongue (sublingual) and taken as a single daily dose. The label says it should be allowed to dissolve completely. After the tablet is fully dissolved, rinse your mouth with water and swallow. Wait at least one hour before brushing your teeth. Tell your dentist that you take this medicine. The label says the medicine is started in people who have been initially treated with buprenorphine sublingual tablets, and that the dose is adjusted over time. Follow the instructions from your prescriber or pharmacist.

Comes as

• •Orange, round, flat-faced tablet with a beveled edge, marked with the strength
• •2 mg buprenorphine with 0.5 mg naloxone sublingual tablets (per the description section)
• •8 mg buprenorphine with 2 mg naloxone sublingual tablets (listed in the dosage forms section)

⚠️ Buprenorphine and Naloxone side effects

🛑 Who should not take Buprenorphine and Naloxone, and who should be careful

The label says not to take it if

• 🚨You are allergic to buprenorphine or naloxone. The label says serious allergic reactions, including anaphylactic shock, have been reported.
• 🚨You plan to take it with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants, including street drugs. The label says this can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• 🚨You plan to inject it. The label says injecting this medicine may cause life-threatening infections and other serious health problems, as well as sudden serious withdrawal symptoms.

Tell your doctor before taking it if

• •Tell your healthcare provider about all your medical conditions, including trouble breathing or lung problems, an enlarged prostate, a head injury or brain problem, a spine curve that affects breathing, urinary problems, mental health problems, Addison's disease, liver, kidney, or gallbladder problems, adrenal or thyroid gland problems, alcoholism, and tooth problems or a history of cavities.
• •Tell your provider if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.
• •Tell your provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• •Tell your provider if you live in a household with small children.
• •The label says the medicine is not appropriate as a pain reliever (analgesic). It also says deaths have been reported in people who were not already taking opioids and received a 2 mg sublingual dose.
• •Do not stop taking this medicine suddenly. The label says you could become sick and have withdrawal symptoms. It says to taper gradually when stopping treatment.
• •Do not switch to other medicines that contain buprenorphine without talking with your provider. The label says the amount of buprenorphine in this product is not the same as in other buprenorphine medicines.
• •Keep the medicine in a secure place out of sight and reach of children and others in the home. The label says never to give it to anyone else and that selling or giving it away is against the law.
• •The label says to have family members tell emergency staff that you are physically dependent on an opioid and are being treated with this medicine.
• •Ask your provider about medicines like naloxone or nalmefene, which the label says can be used in an emergency to reverse an opioid overdose.

🔀 Buprenorphine and Naloxone with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •Benzodiazepines, other central nervous system depressants, and alcohol: The label says these can increase the risk of low blood pressure, breathing problems, deep sleepiness, coma, and death. The label also lists gabapentinoids, other opioids, and muscle relaxants among these examples. Your prescriber may consider stopping or lowering the other medicine, and may consider an overdose reversal agent.
• •CYP3A4 inhibitors: The label says these can increase buprenorphine levels, causing stronger or longer opioid effects. When the inhibitor is stopped, buprenorphine levels may drop, which can lead to less effect or withdrawal. The label says the dose may need to be reduced in some cases.
• •Tell your provider about all medicines, supplements, and vitamins you take.

Alcohol and food

The label says alcohol should not be combined with this medicine, because alcohol is a central nervous system depressant that can increase the risk of serious breathing problems, coma, and death. The label does not give food instructions in the part provided.

🤰 Buprenorphine and Naloxone in pregnancy and breastfeeding

Pregnancy

The label says data on buprenorphine in pregnancy are limited, and these data do not show an increased risk of major malformations specifically due to buprenorphine. The label says neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged opioid use during pregnancy. Talk with your healthcare provider if you are pregnant or plan to become pregnant.

Breastfeeding

The label says buprenorphine and naloxone can pass into breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby. If you breastfeed, the label says to monitor your baby for increased drowsiness and breathing problems.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store the tablets at 20 to 25 degrees C (68 to 77 degrees F). Store them securely, out of sight and reach of children, and in a place not accessible by others, including visitors to the home. Dispose of the medicine properly.

If a dose is missed

The label does not say.

If too much is taken

The label says overdose signs can include pinpoint pupils, sedation, low blood pressure, low blood sugar, slowed breathing, and death. Toxic leukoencephalopathy has been reported after opioid overdose and can appear hours, days, or weeks after apparent recovery. The label says naloxone or nalmefene can be used in an emergency to reverse an opioid overdose. Call 911 or get emergency medical help right away if an overdose is known or suspected. Medical staff may monitor breathing, heart function, and provide oxygen, IV fluids, and other supportive care.

🗒️ Questions to ask about Buprenorphine and Naloxone

• How should I place and dissolve this tablet, and how long should I wait before brushing my teeth?
• What should I do if I miss a dose, and who should I call if I have questions about my dose?
• Which of my current medicines, including over-the-counter products, could be unsafe to take with this one?
• Should I have an opioid overdose reversal medicine, such as naloxone, at home?
• What signs of breathing problems should I watch for, and when should I call 911?
• If I am pregnant or breastfeeding, what plan should we follow?
• What steps should I take if I need to stop this medicine, so I do not have withdrawal symptoms?

❓ Buprenorphine and Naloxone: frequently asked questions