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buprenorphine (oral/sublingual)

Pronunciation

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. An opioid is 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.

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

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

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.

Tell your doctor if you are pregnant. Buprenorphine may cause life-threatening withdrawal symptoms in a newborn.

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

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.

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;

  • abnormal curvature of the spine that affects breathing;

  • liver disease (especially hepatitis B or C);

  • kidney disease;

  • enlarged prostate, urination problems;

  • problems with your stomach, gallbladder, adrenal gland, or thyroid;

  • a history of head injury or brain tumor;

  • a history of alcohol addiction, hallucinations, or mental illness;

  • a history of methadone use; or

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

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

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 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 pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet

Never crush or break a buprenorphine pill or mix it into a liquid to inject the drug into your vein. This could result in a life-threatening infection or other serious medical problems.

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, fainting, slow heart rate, weak pulse, weak or shallow breathing (breathing may stop).

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.

Call your doctor at once if you have:

  • chest pain, trouble breathing;

  • weak or shallow breathing;

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

  • severe dizziness, loss of coordination;

  • confusion, unusual thoughts or behavior;

  • infertility, missed menstrual periods;

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

  • 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:

  • constipation, nausea, vomiting;

  • headache;

  • 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.

See also: Side effects (in more detail)

Buprenorphine dosing information

Usual Adult Dose for Opiate Dependence:

To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):
Induction dose:
-Day 1: 8 mg sublingually once a day
-Day 2: 16 mg sublingually once a day
Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear.
-Following induction, combination buprenorphine/naloxone is preferred; use of buprenorphine alone should be limited to those patients who cannot tolerate naloxone.

Use: For the treatment of opioid dependence, preferably induction only.

Buprenorphine IMPLANT for Subdermal Administration:
-For opioid tolerant patients only
-Insert 1 dose subdermally in the inner side of the upper arm
-Remove implant at the end of the sixth month

Comments:
-Insertions and removals of implant should be performed by a certified healthcare provider.
-One dose consists of 4 implants; each implant contains buprenorphine 74.2 mg (equivalent to 80 mg buprenorphine hydrochloride).
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal product for continued treatment; there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Use: For the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a BTOD.

Patients chosen for implant use should meet all of the following criteria:
-Achieved and sustained prolonged clinical stability on an acceptable BTOD maintenance dose for 3 months or longer without any need for supplemental dosing or adjustments
Acceptable BTOD maintenance doses include:
--buprenorphine sublingual tablets (Subutex[R]) or generic equivalent at 8 mg or less per day
--buprenorphine/naloxone sublingual tablets (Suboxone[R]) or generic equivalent at 8 mg/2 mg or less per day
--buprenorphine/naloxone buccal film (Bunavail[R]) at 4.2 mg/0.7 mg or less per day
--buprenorphine/naloxone sublingual tablets (Zubsolv[R]) at 5.7 mg/1.4 mg or less per day
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Usual Adult Dose for Pain:

Parenteral:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.3 mg (IV) or 0.6 mg (IM)

Comments:
-Use extra caution with IV administration, especially the first dose

Use: For the relief of moderate to severe pain

Usual Adult Dose for Chronic Pain:

Individualize dosing taking into account prior analgesic treatment; 7.5 mcg, 10 mcg, 15 mcg, and 20 mcg/hr patches are for opioid-experienced patients only.

-As first opioid analgesic: Initiate with 5 mcg/hr patch applied transdermally every 7 days

Conversion from Other Opioids to Buprenorphine:
-Discontinue all other around-the-clock opioid drugs when initiating therapy
For patients whose prior total opioid dose is less than 30 mg/day of oral morphine equivalents:
-Initiate with 5 mcg/hr patch applied transdermally every 7 days at next dosing interval
For patients whose prior total opioid dose is between 30 and 80 mg/day of oral morphine equivalents:
-Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day of oral morphine equivalents, then initiate with 10 mcg/hr patch applied transdermally every 7 days starting at the next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained.
For patients whose prior total opioid dose is greater than 80 mg/day of oral morphine equivalents:
-Consider use of an alternate analgesic as 20 mcg/hr patch may not provide adequate analgesia

Conversion from Methadone:
-The ratio between methadone and other opioid agonists may vary widely due to its long half-life and accumulation in the plasma; close monitoring is of particular importance.

Titration: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
Maximum dose: 20 mcg/hr due to risk of QTc interval prolongation

Comments:
-Monitor patients closely for respiratory depression, especially within 24 to 72 hours after initiating therapy.
-If pain level increases after dose stabilization, attempt to identify source of increased pain before increasing buprenorphine dose
-Do not abruptly discontinue; use a gradual downward titration every 7 days, may consider introduction of 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:

Parenteral:
13 years or older:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes) ; may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.3 mg

2 to 12 years: 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

Comments:
-Fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established.
-Use extra caution with IV administration, especially the first dose

Use: For the relief of moderate to severe pain

Usual Pediatric Dose for Opiate Dependence:

Aged 16 years or older: To be used as part of a complete treatment plan to include counseling and psychosocial support:

Buprenorphine TRANSMUCOSAL Products for Opioid Dependence (BTOD):
Induction dose:
-Day 1: 8 mg sublingually once a day
-Day 2: 16 mg sublingually once a day
Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear.
-Following induction, combination buprenorphine/naloxone is preferred; use of buprenorphine alone should be limited to those patients who cannot tolerate naloxone.

Use: For the treatment of opioid dependence, preferably induction only.

Buprenorphine IMPLANT for Subdermal Administration:
-For opioid tolerant patients only
-Insert 1 dose subdermally in the inner side of the upper arm
-Remove implant at the end of the sixth month

Comments:
-Insertions and removals of implant should be performed by a certified healthcare provider.
-One dose consists of 4 implants; each implant contains buprenorphine 74.2 mg (equivalent to 80 mg buprenorphine hydrochloride).
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal product for continued treatment; there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Use: For the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a BTOD.

Patients chosen for implant use should meet all of the following criteria:
-Achieved and sustained prolonged clinical stability on an acceptable BTOD maintenance dose for 3 months or longer without any need for supplemental dosing or adjustments
Acceptable BTOD maintenance doses include:
--buprenorphine sublingual tablets (Subutex[R]) or generic equivalent at 8 mg or less per day
--buprenorphine/naloxone sublingual tablets (Suboxone[R]) or generic equivalent at 8 mg/2 mg or less per day
--buprenorphine/naloxone buccal film (Bunavail[R]) at 4.2 mg/0.7 mg or less per day
--buprenorphine/naloxone sublingual tablets (Zubsolv[R]) at 5.7 mg/1.4 mg or less per day
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

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:

  • 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.

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: 5.04.

Date modified: November 30, 2016
Last reviewed: September 29, 2016

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