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buprenorphine (oral/sublingual)

Generic Name: buprenorphine (oral/sublingual) (BUE pre NOR feen (OR al / sub LIN gwal))
Brand Name: Subutex

What is buprenorphine sublingual?

Buprenorphine is an opioid medication, sometimes called a narcotic.

Buprenorphine oral (sublingual, given under the tongue) is used to treat narcotic addiction. Buprenorphine sublingual tablets are not for use as a pain medication.

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

Important Information

Buprenorphine sublingual tablets are not for use as a pain medication.

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

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

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

Before taking this medicine

You should not use this medicine if you are allergic to buprenorphine, or:

  • if you have used another narcotic drug within the past 4 hours.

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

Some medicines can interact with buprenorphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or 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.

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.

This medicine can pass into breast milk and cause drowsiness or breathing problems in a nursing baby. Tell your doctor if you are breast-feeding.

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

How should I take buprenorphine sublingual?

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.

Buprenorphine sublingual is usually taken for only 1 or 2 days at the start of treatment for addiction. Most people are later switched to another medicine called buprenorphine/naloxone (Bunavail, Suboxone, Zubsolv).

You may receive your first doses of buprenorphine sublingual in a hospital or clinic setting until your condition improves.

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.

Use dry hands when handling the tablet. Place the tablet under your tongue and allow it to dissolve with your mouth closed. Do not chew the tablet or swallow it whole.

If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.

Do not eat or drink anything until the tablet or 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.

Never crush or break a buprenorphine pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Wear a medical alert tag or carry an ID card stating that you take buprenorphine. Any medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

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

Store at room temperature away from moisture and heat.

Keep track of the amount 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 this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

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, pinpoint pupils, slow heart rate, weak pulse, very slow breathing, or coma.

What should I avoid while taking buprenorphine sublingual?

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 sublingual 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.

A person caring for you should 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;

  • slow heartbeat or weak pulse;

  • a light-headed feeling, like you might pass out;

  • chest pain, trouble breathing;

  • 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.

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

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.

See also: Side effects (in more detail)

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:

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

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

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 sublingual?

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:

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.

Where can I get more information?

  • Your pharmacist can provide more information about buprenorphine sublingual.
  • 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: 7.01.

Date modified: January 03, 2018
Last reviewed: December 12, 2017

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