Belbuca

Generic name: Buprenorphine (oral/buccal)
Drug class: Opioids (narcotic analgesics)

Usage of Belbuca

Belbuca buccal films contain Buprenorphine, an opioid medication. An opioid is sometimes called a narcotic.

Belbuca buccal films are for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines.

Belbuca is not for use on an as-needed basis for occasional pain.

The Belbuca buccal film is placed between the gum and cheek where it adheres to the moist buccal mucosa to deliver the medicine as the film dissolves.

Belbuca side effects

Get emergency medical help if you have signs of an allergic reaction to Belbuca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • slow heartbeat or weak pulse;
  • a light-headed feeling, like you might pass out;
  • chest pain, fast heart rate, trouble breathing;
  • severe constipation;
  • opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
  • low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

    • Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

    Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

    Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

    Common Belbuca side effects may include:

  • constipation, nausea, vomiting;
  • headache, dizziness, drowsiness;
  • increased sweating;
  • sleep problems (insomnia); or
  • pain anywhere in your body.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Belbuca

    You should not use Belbuca if you are allergic to buprenorphine, or if you have:

  • severe asthma or trouble breathing, or a blockage in your stomach or intestines.

    • To make sure Belbuca is safe for you, tell your doctor if you have ever had:

  • tooth problems, including a history of cavities;
  • breathing problems, sleep apnea;
  • kidney or liver disease (especially hepatitis B or C);
  • enlarged prostate, urination problems;
  • problems with your gallbladder, pancreas, or thyroid;
  • a head injury, brain tumor, or seizures;
  • drug addiction, methadone use, alcoholism, mental illness;
  • mouth sores caused by cancer;
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
  • long QT syndrome, or if you take heart rhythm medication.

    • If you use Belbuca while you are pregnant, your baby could become Dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

    Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breastfeed while you are using Belbuca.

    Belbuca is not approved for use by anyone younger than 18 years old.

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    How to use Belbuca

    Use Belbuca exactly as prescribed by your doctor. Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use Belbuca in larger amounts, or for longer than prescribed. Tell your doctor if Belbuca seems to stop working as well in relieving your pain.

    Buprenorphine may be habit-forming, even at regular doses. Never share Belbuca with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using Belbuca without a prescription. Selling or giving away Belbuca is against the law.

    Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

    Place the Belbuca film against the inside of your cheek and hold it in place for 5 seconds. Once in place, the film will dissolve completely in about 30 minutes. Rinse your mouth with water after the medicine dissolves. Wait one hour after the film dissolves to brush your teeth to prevent damage to the teeth and gums. Do not chew the Belbuca film or swallow it whole.

    Do not eat or drink anything until the Belbuca film has completely dissolved in your mouth.

    You should receive regular dental checkups while using Belbuca.

    While using Belbuca, you may need frequent blood tests to check your liver function.

    If you need surgery, tell the surgeon ahead of time that you are using Belbuca.

    Do not stop using Belbuca suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using buprenorphine.

    Store at room temperature away from moisture and heat. Keep Belbuca in a place where a child cannot get to it. Keep track of your medicine. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

    Do not keep leftover opioid medication. Just one dose can cause death in someone using Belbuca accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

    Warnings

    Belbuca can slow or stop your breathing, and may be habit-forming. MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using Belbuca without a prescription.

    Using Belbuca during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

    Fatal side effects can occur if you use Belbuca with alcohol, or with other drugs that cause drowsiness or slow your breathing.

    What other drugs will affect Belbuca

    You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

    Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
  • medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
  • other opioid medications - opioid pain medicine or prescription cough medicine;
  • a sedative like Valium - Diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
  • drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
  • drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

    • This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

    Popular FAQ

    How long opioid withdrawal lasts depends on the opioid you have been taking and whether it is a short-acting or long acting opioid. If you have been using a short-acting opioid, acute opioid withdrawal lasts 4 to 10 days, with withdrawal symptoms starting 8 to 24 hours after last use. If you have been using a long-acting opioid, acute opioid withdrawal lasts 10 to 20 days, with withdrawal symptoms starting 12 to 48 hours after last use. Continue reading

    After one sublingual or buccal dose, buprenorphine stays in your system for about 5 to 8 days if you are healthy or 7 to 12 days if you have liver disease. Continue reading

    It is available in a number of dosage forms under the brand names Sublocade, Brixadi, Probuphine (discontinued), Belbuca, Butrans, Buprenex, and Subutex (discontinued). Continue reading

    Sublocade and Brixadi are both subcutaneous long-acting buprenorphine injections that may be used for the maintenance treatment of opioid misuse disorder in adults. Sublocade was approved on November 30, 2017, and Brixadi was approved on May 23, 2023. Sublocade is administered once a month, with a minimum of 26 days between doses. If extended travel is deemed necessary, a single 300mg injection may be given to cover 2 months. Brixadi is given once a week or once a month. Continue reading

    Buprenorphine and naloxone is a combination medicine used for the maintenance treatment of opioid dependence in adults. It is available in sublingual film and sublingual tablet dosage forms under the brand names Suboxone, Zubsolv, Bunavail (discontinued), and Cassipa (discontinued). Continue reading

    There is no one-size-fits-all treatment duration for patients taking buprenorphine. There are many factors involved in determining the length of treatment when administering buprenorphine. Continue reading

    Yes, Buprenex is the brand name for an injectable form of buprenorphine. Buprenex (generic name: buprenorphine) is a potent opioid (narcotic) medication used to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Continue reading

    How long opioid withdrawal lasts depends on the opioid you have been taking and whether it is a short-acting or long acting opioid. If you have been using a short-acting opioid, acute opioid withdrawal lasts 4 to 10 days, with withdrawal symptoms starting 8 to 24 hours after last use. If you have been using a long-acting opioid, acute opioid withdrawal lasts 10 to 20 days, with withdrawal symptoms starting 12 to 48 hours after last use. Continue reading

    After one sublingual or buccal dose, buprenorphine stays in your system for about 5 to 8 days if you are healthy or 7 to 12 days if you have liver disease. Continue reading

    It is available in a number of dosage forms under the brand names Sublocade, Brixadi, Probuphine (discontinued), Belbuca, Butrans, Buprenex, and Subutex (discontinued). Continue reading

    Sublocade and Brixadi are both subcutaneous long-acting buprenorphine injections that may be used for the maintenance treatment of opioid misuse disorder in adults. Sublocade was approved on November 30, 2017, and Brixadi was approved on May 23, 2023. Sublocade is administered once a month, with a minimum of 26 days between doses. If extended travel is deemed necessary, a single 300mg injection may be given to cover 2 months. Brixadi is given once a week or once a month. Continue reading

    Buprenorphine and naloxone is a combination medicine used for the maintenance treatment of opioid dependence in adults. It is available in sublingual film and sublingual tablet dosage forms under the brand names Suboxone, Zubsolv, Bunavail (discontinued), and Cassipa (discontinued). Continue reading

    There is no one-size-fits-all treatment duration for patients taking buprenorphine. There are many factors involved in determining the length of treatment when administering buprenorphine. Continue reading

    Yes, Buprenex is the brand name for an injectable form of buprenorphine. Buprenex (generic name: buprenorphine) is a potent opioid (narcotic) medication used to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Continue reading

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