Description
Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction. Buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet is used for induction and maintenance treatment of opioid (narcotic) dependence. It should be used in patients who have already been treated with buprenorphine sublingual tablets.
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 and naloxone combination. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Film
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Isocarboxazid
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Naltrexone
- Phenelzine
- Piperaquine
- Posaconazole
- Safinamide
- Samidorphan
- Saquinavir
- Sparfloxacin
- Terfenadine
- Ziprasidone
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.
- Acecainide
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clonidine
- Yohimbine
Other Interactions
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.
- Ethanol
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 dependence, or history of or
- Asthma, severe or
- Brain tumor, history of or
- Breathing problems, severe (eg, hypoxia, hypercapnia, sleep apnea) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious heart condition) or
- Depression, history of or
- Drug abuse or dependence, especially with narcotics, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Gallbladder problems or
- Head injuries, 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
- Hypomagnesemia (low magnesium in the blood), severe or
- Hypothyroidism (an underactive thyroid) or
- Hypovolemia (low blood volume) or
- Increased pressure in the head or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Mental health problems, history of or
- Problems with passing urine or
- Stomach problems—Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure)—Use with caution. May make this condition worse.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe—Should not be used in patients with this condition.
Proper Use
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 medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you are using the buccal film:
- Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
- Do not cut or tear the film. Hold the film on a clean, dry finger. If you are using Bunavail®, hold with the text (BN2, BN4, or BN6) facing up.
- Place the side of the film against the inside of your cheek. If you are using Bunavail®, place with the text (BN2, BN4, or BN6) against the inside of your cheek.
- Press the film and hold it there for 5 seconds.
- Leave the film in place until it dissolves. Do not touch, move, chew, or swallow it.
- If you must use more than one film, place the second film on the other side of your mouth. Do not place more than 2 buccal films to the inside of one cheek at a time.
- Do not eat or drink anything until the film is completely dissolved.
- After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.
If you are using the sublingual tablet:
- Do not cut, crush, chew, or swallow it.
- 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 in different places under the tongue at the same time.
- If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all the tablets have been taken.
- Do not eat or drink anything until the tablets are completely dissolved.
- Rinse your mouth with water and swallow. Wait at least one hour before brushing your teeth.
If you are using the sublingual film:
- Drink water before taking this medicine to help moisten your mouth.
- Place the film under the tongue until it is dissolved.
- If you need to take an additional film, place the new film on the opposite side from the first film.
- Do not eat or drink anything until the film is completely dissolved.
- Do not cut, chew, swallow, or move the film after placing it under the tongue.
- After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.
Check with your doctor first before changing dosage forms (eg, films, tablets) or dosage strengths. These forms are very different from each other.
Dosing
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 induction treatment of opioid dependence:
- Adults—On Day 1, your doctor may give you an induction dosage up to 4.2 milligrams (mg) of buprenorphine and 0.7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8.4 mg of buprenorphine and 1.4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
- Adults—8.4 milligrams (mg) of buprenorphine and 1.4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For induction treatment of opioid dependence:
- For buccal or sublingual dosage form (film):
- For induction treatment of opioid dependence:
- Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
- Adults—4 milligrams (mg) of buprenorphine and 1 mg of naloxone to 24 mg of buprenorphine and 6 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For induction treatment of opioid dependence:
- For sublingual dosage form (tablets):
- For induction treatment of opioid dependence:
- Adults—On Day 1, your doctor may give you an induction dosage up to 5.7 milligrams (mg) of buprenorphine and 1.4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11.4 mg of buprenorphine and 2.9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
- Adults—2.9 milligrams (mg) of buprenorphine and 0.71 mg of naloxone to 17.2 mg of buprenorphine and 4.2 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For induction treatment of opioid dependence:
Missed Dose
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.
Storage
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.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
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 tests may be needed to check for unwanted effects.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused films or tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
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 too much of this medicine may cause an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position or sitting position, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness or weakness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine may cause serious tooth problems. Tell your doctor right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss. Schedule regular dental checkups while taking 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 and naloxone combination.
This medicine will add to the effects of alcohol and other 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 allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using this medicine while you are pregnant may cause neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble with breathing or 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.
Do not suddenly stop using it without first 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, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
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.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
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:
More common
- Chills
- cough
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- fever
- flushing or redness of the skin, especially on the face and neck
- headache
- hoarseness
- lower back or side pain
- painful or difficult urination
- sweating
Incidence not known
- Agitation
- anxiety
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest tightness
- cold sweats
- coma
- cool, pale skin
- darkening of the skin
- depression
- diarrhea
- difficulty swallowing
- dizziness
- fainting
- fast heartbeat
- hives, itching, skin rash
- increased hunger
- loss of appetite
- mental depression
- nausea
- nervousness
- nightmares
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- restlessness shivering talking or acting with excitement you cannot control
- seizures
- shakiness
- slurred speech
- tingling of the hands or feet
- toothache
- trembling or shaking twitching
- unusual weight gain or loss
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- confusion
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- irregular, fast, slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm feeling
- sleepiness
- unusual tiredness or weakness
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:
More common
- Difficulty having a bowel movement
- lack or loss of strength
- stomach pain
- trouble sleeping
Less common
- Back pain
- diarrhea
- runny or stuffy nose
- sneezing
Incidence not known
- Burning or sore mouth
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings inside the mouth
- decline or loss of libido or sexual desire
- irritability
- mood swings
- poor concentration
- redness, swelling, or soreness of the tongue
- reduced muscle strength
- swelling, inflammation, or redness of the mouth
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.
DRG-20074097
