Bunavail

Name: Bunavail

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What Is Bunavail?

Buprenorphine is an opioid medication. An opioid is sometimes called a narcotic.

Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication.

Buprenorphine and naloxone may also be used for purposes not listed in this medication guide.

This medicine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine and naloxone may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use this medicine if you are allergic to buprenorphine or naloxone (Narcan).

To make sure buprenorphine and naloxone is safe for you, tell your doctor if you have:

any type of breathing problem or lung disease;
enlarged prostate, urination problems;
liver or kidney disease;
curvature of the spine that affects breathing;
problems with your gallbladder, adrenal gland, or thyroid;
a history of drug abuse, alcohol addiction, or mental illness; or
a history of head injury, brain tumor, or seizures.

It is not known whether this medicine will harm an unborn baby. If you use buprenorphine and naloxone 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.

Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Bunavail Drug Class

Bunavail is part of the drug class:

Drugs used in opioid dependence

Side Effects of Bunavail

Serious side effects have been reported with Bunavail. See the “Bunavail Precautions” section.

Common side effects of Bunavail include the following:

Headache
Drug withdrawal syndrome
Nausea
Decrease in sleep (insomnia)
Vomiting
Pain
Increased sweating
Constipation

This is not a complete list of Bunavail side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Bunavail and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bunavail falls into category C. There are no well-controlled studies that have been done in pregnant women. Bunavail should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Bunavail and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Buprenorphine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Bunavail, a choice should be made whether to stop nursing or to stop use of this medication. Caution should be exercised when Bunavail is administered to a nursing woman. The importance of the drug to the mother should be considered.

Bunavail Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

the condition being treated
how you respond to this medication

Apply Bunavail buccal film as a single daily dose.

The recommended daily dose for maintenance is 8.4 mg/1.4 mg.

Other Requirements

Store Bunavail at at 20-25°C (68-77°F).
Protect Bunavail from freezing and moisture. Do not use if the foil package has been damaged.
Keep this and all medicines out of the reach of children.

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

Before Using Bunavail

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, 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 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.

Nalmefene
Naltrexone
Safinamide

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.

Acepromazine
Alfentanil
Almotriptan
Alprazolam
Amineptine
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Aripiprazole
Asenapine
Atazanavir
Baclofen
Benperidol
Benzphetamine
Bromazepam
Bromopride
Brompheniramine
Buspirone
Butabarbital
Butorphanol
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Chloral Hydrate
Chlordiazepoxide
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Citalopram
Clobazam
Clomipramine
Clonazepam
Clorazepate
Clozapine
Cocaine
Codeine
Cyclobenzaprine
Desipramine
Desmopressin
Desvenlafaxine
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Eletriptan
Enflurane
Escitalopram
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Flibanserin
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fospropofol
Frovatriptan
Furazolidone
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Imipramine
Iproniazid
Isocarboxazid
Isoflurane
Ketamine
Ketazolam
Ketobemidone
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lorazepam
Lorcaserin
Loxapine
Meclizine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Midazolam
Milnacipran
Mirtazapine
Moclobemide
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Naldemedine
Naloxegol
Naratriptan
Nefazodone
Nialamide
Nicomorphine
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Palonosetron
Papaveretum
Paregoric
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Prazepam
Primidone
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propofol
Protriptyline
Quazepam
Quetiapine
Ramelteon
Rasagiline
Remifentanil
Remoxipride
Rizatriptan
Secobarbital
Selegiline
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
St John's Wort
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Tranylcypromine
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Venlafaxine
Vilazodone
Vortioxetine
Zaleplon
Ziprasidone
Zolpidem
Zopiclone
Zotepine

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

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 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

Proper Use of buprenorphine/naloxone

This section provides information on the proper use of a number of products that contain buprenorphine/naloxone. It may not be specific to Bunavail. Please read with care.

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 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 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 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 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 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 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—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 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.