Buprenorphine (Buccal mucosa route, sublingual route)
Warnings:Buccal mucosa route(Film)
Buprenorphine has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in uncontrolled delivery which may lead to overdose and death. Accidental exposure to buprenorphine, especially in children, can result in fatal overdose of buprenorphine. Prolonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
Buprenorphine buccal film is used to relieve severe pain that is constant. This medicine is not used for minor pain or pain that only sometimes occurs. It acts on the central nervous system (CNS) to relieve pain.
Buprenorphine sublingual tablet is used to treat opioid (narcotic) dependence or addiction. When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine. It acts on the central nervous system (CNS) to help prevent withdrawal side effects.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine in the elderly. However, elderly patients are more likely to have age-related lung, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine in order to avoid potentially serious side effects.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Methylene Blue
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Asthma, severe or
- Brain tumor, history of or
- Breathing problems, severe (eg, hypercapnia, hypoxia, apnea) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious heart condition) or
- Drug dependence, especially with narcotics, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Gallbladder disease or gallstones or
- Head injury, history of or
- Heart disease (eg, angina, congestive heart failure) or
- Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
- Hepatitis B or C, history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Hypovolemia (low blood volume) or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Problems with passing urine—Use with caution. May increase risk for more serious side effects.
- Constipation or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas), history of or
- Respiratory depression (very slow breathing) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Mucositis (mouth sores or ulcers)—Use with caution. The effects of the Belbuca™ film may be increased because of more drug being absorbed.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use the buccal film:
- Do not place the medicine on areas of the mouth with sores or lesions.
- Use your tongue to wet the inside of your cheek or rinse your mouth with water before placing the film in your mouth.
- Place the yellow side of the film against the inside of your cheek.
- Press against the film and hold it there with clean, dry fingers for 5 seconds.
- Leave the film in place until it dissolves and do not touch or move the film. Do not chew or swallow the film.
- Do not eat or drink anything until the film is completely dissolved, which is usually within 30 minutes.
Do not crush or swallow the sublingual tablet. Place the tablet under the tongue until it is dissolved. If you take 2 or more tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For buccal dosage form (film):
- For severe pain:
- Adults—At first, 75 micrograms (mcg) as a single dose once a day or every 12 hours. Your doctor may adjust your dose as needed. However, the dose is usually not more than 900 mcg every 12 hours.
- Children—Use and dose must be determined by your doctor.
- For severe pain:
- For sublingual dosage form (tablets):
- For maintenance treatment of opioid dependence:
- Adults—4 to 24 milligrams (mg) as a single dose once a day.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Unused tablets should be flushed down the toilet. Unused buccal films should be removed from the foil packaging first, then flushed down the toilet.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets and buccal films in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS) depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, benzodiazepines, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, barbiturates or seizures medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
If you have been using this medicine regularly for several weeks or longer, do not suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Blurred vision
- difficult or troubled breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular, fast, slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm feeling
- unusual tiredness or weakness
- More common
- Back pain
- cough or hoarseness
- difficulty having a bowel movement (stool)
- fever or chills
- lower back or side pain
- painful or difficult urination
- runny nose
- stomach pain
- stuffy nose
- trouble sleeping
- Less common
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- lack or loss of strength
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017