Important: How To Use This Information
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Buprenorphine has a risk for abuse and addiction, which can lead to overdose and death. Buprenorphine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you use the smallest dose of buprenorphine that works, and use it for the shortest possible time. See also How to Use section for more information about addiction.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you use the wrong dose/strength. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to use buprenorphine and what other drugs you should avoid using with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Buprenorphine is used to help relieve moderate to severe pain. Buprenorphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.
How To Use
This medication is given by injection into a vein or muscle by a health care professional, as directed by your doctor.
The dosage is based on your medical condition and response to treatment.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your pain does not get better or if it gets worse.
See also Warning section.
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while. Redness, itching, or irritation at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including:
- interrupted breathing during sleep (sleep apnea)
- mental/mood changes (such as agitation, confusion, hallucinations)
- difficulty urinating
- signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss)
Get medical help right away if you have any very serious side effects, including:
- slow/shallow breathing
- severe drowsiness/difficulty waking up
- fast/irregular heartbeat
- severe dizziness
Buprenorphine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including:
- nausea/vomiting that doesn't stop
- loss of appetite
- stomach/abdominal pain
- yellowing eyes/skin
- dark urine
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using buprenorphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
- brain disorders (such as head injury, tumor, seizures)
- breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD)
- gallbladder disease
- kidney disease
- liver disease
- mental/mood disorders (such as confusion, depression, thoughts of suicide)
- personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
- stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus)
- disease of the pancreas (pancreatitis)
- difficulty urinating (such as due to enlarged prostate)
Buprenorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using buprenorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:
- certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
- family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using buprenorphine safely.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug are:
- certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol)
Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, disopyramide, quinidine, procainamide, sotalol, among others.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness.
This medication may interfere with certain lab tests (such as amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, coma.
Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.
Information last revised October 2019.
Copyright(c) 2019 First Databank, Inc.
Conditions of use: The information in this database is intended to supplement, not substitute for the expertise and judgment of healthcare professionals. The information in not intend to cover all possible uses, directions, precautions, drug interactions or adverse effects nor should it be construed in indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.