buprenorphine/naloxone (Oromucosal route, Sublingual route)

bue-pre-NOR-feen, nal-OX-one

Commonly used brand name(s)

In the U.S.

• Bunavail
• Suboxone
• Zubsolv

Available Dosage Forms:

• Tablet
• Film

Therapeutic Class: Opioid Dependency

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

Uses For buprenorphine/naloxone

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 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.

buprenorphine/naloxone is available only with your doctor's prescription.

Before Using buprenorphine/naloxone

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 buprenorphine/naloxone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to buprenorphine/naloxone 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 tablet, or sublingual film 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, or heart problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

Pregnancy

	Pregnancy Category	Explanation
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.

Breast Feeding

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.

Interactions with Medicines

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 buprenorphine/naloxone, 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 buprenorphine/naloxone 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.

• Naltrexone

Using buprenorphine/naloxone 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.

• Alfentanil
• Alphaprodine
• Alprazolam
• Amobarbital
• Anileridine
• Atazanavir
• Baclofen
• Bromazepam
• Buspirone
• Butabarbital
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasabuvir
• Delavirdine
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Donepezil
• Doxylamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Fentanyl
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fospropofol
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Idelalisib
• Ketazolam
• Ketobemidone
• Levorphanol
• Lorazepam
• Meclizine
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Midazolam
• Mitotane
• Morphine
• Morphine Sulfate Liposome
• Naloxegol
• Nelfinavir
• Nilotinib
• Nitrazepam
• Ombitasvir
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Paritaprevir
• Pentazocine
• Pentobarbital
• Phenobarbital
• Piperaquine
• Prazepam
• Primidone
• Promethazine
• Propofol
• Propoxyphene
• Quazepam
• Ramelteon
• Secobarbital
• Siltuximab
• Sodium Oxybate
• Sufentanil
• Suvorexant
• Tapentadol
• Telaprevir
• Temazepam
• Thiopental
• Thioridazine
• Tipranavir
• Tizanidine
• Topiramate
• Topotecan
• Triazolam
• Zaleplon
• Zolpidem
• Zopiclone

Using buprenorphine/naloxone 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
• Darunavir
• Etravirine
• Fosamprenavir
• Perampanel
• Yohimbine

Interactions with Food/Tobacco/Alcohol

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 buprenorphine/naloxone 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 buprenorphine/naloxone, 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 buprenorphine/naloxone. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Asthma, severe or
• Brain tumor, history of or
• Breathing problems, severe (eg, hypoxia, hypercapnia) or
• Chronic obstructive pulmonary disease (COPD) or
• CNS depression 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 injuries, history of or
• Heart disease or
• Hepatitis B or C, history of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Mental illness or
• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Hypotension (low blood pressure) or
• Respiratory depression (very slow breathing)—Use with caution. May make these conditions worse.

• Kidney disease or
• 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 of buprenorphine/naloxone

Take buprenorphine/naloxone 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.

buprenorphine/naloxone 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 with the text (BN2, BN4, or BN6) facing up.
• Place the side of the film 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 and do not touch or move the film. Do not chew or swallow the film.
• 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.

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 tablets have been taken.
• Do not eat or drink anything until the tablets are completely dissolved.

If you are using the sublingual film:

• Drink water before taking buprenorphine/naloxone 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 cut, chew, swallow, or move the film after placing it under the tongue.

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 buprenorphine/naloxone 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 buprenorphine/naloxone. 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 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 sublingual dosage form (film):
  • For maintenance treatment of opioid dependence:
    • Adults—16 milligrams (mg) of buprenorphine and 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 sublingual dosage form (tablets):
  • For maintenance treatment of opioid dependence:
    • Adults—11.4 milligrams (mg) of buprenorphine and 2.9 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 treatment of opioid dependence:
    • Adults—8 to 16 milligrams (mg) as a single dose once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of buprenorphine/naloxone, 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.

Flush any unused Bunavail™ films, Suboxone® films, and Zubsolv® tablets down the toilet.

Precautions While Using buprenorphine/naloxone

It is very important that your doctor check your progress while you are using buprenorphine/naloxone. 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.

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 buprenorphine/naloxone.

Do not use more of buprenorphine/naloxone or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using buprenorphine/naloxone. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.

buprenorphine/naloxone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or 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. Check with your doctor before taking any of the medicines listed above while you are using buprenorphine/naloxone.

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.

buprenorphine/naloxone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to buprenorphine/naloxone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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.

buprenorphine/naloxone 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 buprenorphine/naloxone.

If you have been using buprenorphine/naloxone 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 buprenorphine/naloxone 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 buprenorphine/naloxone.

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.

buprenorphine/naloxone 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

• Cough or hoarseness
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• fever or chills
• flushing or redness of the skin, especially on the face and neck
• headache
• lower back or side pain
• painful or difficult urination
• sweating

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• confusion
• difficult or troubled 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

• Abdominal or stomach pain
• difficulty having a bowel movement (stool)
• lack or loss of strength
• nausea
• pain
• trouble sleeping
• vomiting

Less common

• Back pain
• diarrhea
• runny nose
• sneezing
• stuffy nose

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.

See also: Side effects (in more detail)

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