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buprenorphine (oral/buccal)

Pronunciation

Generic Name: buprenorphine (oral/buccal) (BUE pre NOR feen (OR al / BUK al))
Brand Name: Belbuca

What is buprenorphine buccal?

Buprenorphine is an opioid medication. An opioid is sometimes called a narcotic.

Buprenorphine oral (buccal, placed between the gum and cheek) is for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines. This medicine is not for use on an as-needed basis for occasional pain.

Buprenorphine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about buprenorphine buccal?

Buprenorphine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose. Never share buprenorphine with another person.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Buprenorphine may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

What should I discuss with my healthcare provider before taking buprenorphine buccal?

You should not use this medicine if you have used another narcotic drug within the past 4 hours, if you are allergic to buprenorphine, or if you have:

  • severe asthma or trouble breathing; or

  • a blockage in your digestive tract, including a bowel obstruction called paralytic ileus.

Some medicines can interact with buprenorphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure buprenorphine is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • liver disease (especially hepatitis B or C);

  • kidney disease;

  • enlarged prostate, urination problems;

  • problems with your gallbladder, pancreas, or thyroid;

  • long QT syndrome, or if you take heart rhythm medication;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • mouth sores caused by cancer;

  • a history of head injury, brain tumor, or seizures;

  • a history of drug abuse, methadone use, alcohol addiction, or mental illness;

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether this medicine will harm an unborn baby. If you use buprenorphine 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 breast-feed while you are using buprenorphine.

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

How should I take buprenorphine buccal?

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

Buprenorphine may be habit-forming, even at regular doses. Never share this medicine 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 the medicine without a prescription. Selling or giving away buprenorphine 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.

Drink a glass of water to moisten your mouth. Use dry hands when handling the buccal film. Place the 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. Do not chew the film or swallow it whole.

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

While using buprenorphine, 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 buprenorphine. You may need to stop using the medicine for a short time.

Do not stop using buprenorphine 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 the medicine in a place where a child cannot get to it. Keep track of the amount of medicine used from each new bottle. 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 buprenorphine buccal films. 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, muscle weakness, pinpoint pupils, fainting, slow heart rate, weak pulse, deep sighs, snoring that is new or unusual, weak or shallow breathing (breathing may stop).

What should I avoid while taking buprenorphine buccal?

Avoid applying the buccal film to an area where you have a mouth sore.

Do not drink alcohol. Dangerous side effects or death could occur.

Buprenorphine may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Buprenorphine buccal side effects

Get emergency medical help if you have signs of an allergic reaction: 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.

Call your doctor at once if you have:

  • chest pain, fast heart rate, trouble breathing;

  • weak or shallow breathing, feeling like you might pass out;

  • severe constipation;

  • infertility, missed menstrual periods;

  • impotence, sexual problems, loss of interest in sex;

  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness;

  • opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain; 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 ill or debilitated.

Common side effects may be more likely to occur, such as:

  • 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.

Buprenorphine dosing information

Usual Adult Dose for Opiate Dependence:

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear AND not less than 4 hours after the patient has last used heroin or other short-acting opioids OR not less than 24 hours after last use of methadone or other long-acting opioids:

INDUCTION:
Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred)
Day 2: 16 mg sublingually once a day

MAINTENANCE:
-Adjust in 2 to 4 mg increments/decrements to a level that holds patient in treatment and suppresses opioid withdrawal signs and symptoms
-Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day
-Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage

Comments:
-This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.
-Buprenorphine (without naloxone) is the preferred drug for induction; buprenorphine/naloxone is the preferred drug for maintenance therapy.
-It is important to achieve adequate treatment doses as rapidly as possible as gradual induction over several days has led to higher dropout rates.
-There is no maximum recommended duration for maintenance therapy as patients may require indefinite treatment; when the decision is made to discontinue, doses should be tapered.

Subdermal IMPLANT: For use in opioid-tolerant patients who meet ALL of the following criteria:
-Achieved and sustained prolonged clinical stability on transmucosal buprenorphine as evidenced by a stable dose for 3 months or longer without any need for supplemental dosing or dose adjustments.
-Currently receiving maintenance buprenorphine (with or without naloxone) doses of 8 mg/day or less, or equivalent transmucosal product (e.g. Bunavail[R] buprenorphine 4.2 mg/naloxone 0.7 mg per day or less; or Zubsolv[R] buprenorphine 5.7 mg/naloxone 1.4 mg per day or less)
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Insert 1 dose subdermally in the inner side of the upper arm
-Remove at the end of the sixth month

Comments:
-Implant insertions and removals should be performed by certified healthcare providers.
-Each dose consists of 4 implants; each implant contains buprenorphine 74.2 mg
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal products for continued treatment as there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Usual Adult Dose for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)
Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Usual Adult Dose for Chronic Pain:

Buccal Film:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: 75 mcg buccally once a day, or if tolerated every 12 hours for at least 4 days; then increase to 150 mcg every 12 hours
-Titrate individually in increments of 150 mcg every 12 hours no more frequently than every 4 days to a dose that provides adequate analgesia and minimizes adverse reactions; doses of 600 mcg, 750 mcg, and 900 mcg should only be used following titration from lower doses
Maximum dose: 900 mcg every 12 hours

Conversion from Other Opioids to Buccal Film: To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg/day oral morphine mg equivalents (MME) before beginning therapy
Discontinue all around-the-clock opioid drugs when initiating buccal film
For opioid dose of less than 30 mg/day MME prior to taper:
-Initial dose: 75 mcg buccally once a day, or every 12 hours
For opioid dose between 30 and 89 mg/day MME prior to taper:
-Initial dose: 150 mcg buccally every 12 hours
For opioid dose between 90 and 160 mg/day MME prior to taper:
-Initial dose: 300 mcg buccally every 12 hours
For opioid doses greater than 160 mg/day MME: Consider alternate analgesics as buccal film may not provide adequate analgesia
Conversion from Methadone: The ratio between methadone as a function of previous dose exposure varies widely; methadone has a long half-life and accumulates in the plasma; close monitoring is of particular importance.

Transdermal System:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: Initiate with 5 mcg/hr patch transdermally; change every 7 days
-Titrate individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
Maximum dose: 20 mcg/hr

Conversion from Other Opioids to Transdermal System:
Discontinue all other around-the-clock opioid drugs when initiating therapy
-For prior opioid dose of less than 30 mg/day oral morphine mg equivalents (MME): Initiate with 5 mcg/hr applied transdermally at next dosing interval
-For prior opioid dose between 30 and 80 mg/day MME: Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day MME; then, initiate with 10 mcg/hr transdermally at next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained
-For prior opioid dose greater than 80 mg/day MME: Consider an alternate analgesic as transdermal therapy may not provide adequate analgesia
Conversion from Methadone: The ratio between methadone as a function of previous dose exposure varies widely; methadone has a long half-life and accumulates in the plasma; close monitoring is of particular importance.

Comments:
-The buccal film and transdermal system should be prescribed by healthcare providers knowledgeable in the use of potent opioids for chronic pain; these products are not for use as as-needed analgesics.
-Monitor patients closely for respiratory depression, especially within 24 to 72 hours after initiating therapy and with dose increases.
-If pain level increases after dose stabilization, attempt to identify source of increased pain before increasing dose; rescue medication with an immediate-release analgesic may be needed.
-Because of the risks of opioid addiction, abuse, and misuse, this drug should be reserved for patients for whom alternative treatment options have not or are not expected to be tolerated; or have not or are not expected to provide adequate analgesia.
-Upon discontinuation, use a gradual downward titration; for patients on transdermal system, may need to switch to an immediate-release opioid.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Usual Pediatric Dose for Pain:

Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours
-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Usual Pediatric Dose for Opiate Dependence:

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear AND not less than 4 hours after the patient has last used heroin or other short-acting opioids OR not less than 24 hours after last use of methadone or other long-acting opioids:

16 years or older:

INDUCTION:
Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred)
Day 2: 16 mg sublingually once a day

MAINTENANCE:
-Adjust in 2 to 4 mg increments/decrements to a level that holds patient in treatment and suppresses opioid withdrawal signs and symptoms
-Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day
-Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage

Comments:
-This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.
-Buprenorphine (without naloxone) is the preferred drug for induction; buprenorphine/naloxone is the preferred drug for maintenance therapy.
-It is important to achieve adequate treatment doses as rapidly as possible as gradual induction over several days has led to higher dropout rates.
-There is no maximum recommended duration for maintenance therapy as patients may require indefinite treatment; when the decision is made to discontinue, doses should be tapered.

Subdermal IMPLANT: For use in opioid-tolerant patients who meet ALL of the following criteria:
-Achieved and sustained prolonged clinical stability on transmucosal buprenorphine as evidenced by a stable dose for 3 months or longer without any need for supplemental dosing or dose adjustments.
-Currently receiving maintenance buprenorphine (with or without naloxone) doses of 8 mg/day or less, or equivalent transmucosal product (e.g. Bunavail[R] buprenorphine 4.2 mg/naloxone 0.7 mg per day or less; or Zubsolv[R] buprenorphine 5.7 mg/naloxone 1.4 mg per day or less)
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Insert 1 dose subdermally in the inner side of the upper arm
-Remove at the end of the sixth month

Comments:
-Implant insertions and removals should be performed by certified healthcare providers.
-Each dose consists of 4 implants; each implant contains buprenorphine 74.2 mg
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal products for continued treatment as there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

What other drugs will affect buprenorphine buccal?

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

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of 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.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about buprenorphine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03.

Date modified: October 13, 2017
Last reviewed: September 28, 2016

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