Cassipa (Oromucosal, Sublingual)

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 starting and ongoing 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, leading to mental or physical dependence. Physical dependence may cause 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 works on the central nervous system (CNS) to help prevent the withdrawal side effects.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress while you are using this medicine. This will help your doctor see if the medicine is working well and decide if you should keep taking it. Blood tests may be needed to check for side effects.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) in the past 14 days.

It is illegal 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 try to steal this medicine.

This medicine can be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.

Taking too much of this medicine can lead to an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficulty breathing, dizziness, faintness, or lightheadedness when getting up suddenly from lying down or sitting, irregular, fast, slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness, or weakness. If you suspect an overdose, call your doctor immediately. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing issues (for example, sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea while using this medicine.

This medicine may lead to serious tooth problems. Inform 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 type of surgery (including dental surgery) or emergency treatment, inform the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if certain medicines are taken with buprenorphine and naloxone combination.

This medicine will enhance the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or reduce alertness. Examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, seizure medicines or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Consult your doctor before taking any of the medicines listed above while using this medicine.

Dizziness, lightheadedness, or fainting may happen when you stand up suddenly from a lying or sitting position. Getting up slowly may help reduce this issue. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may cause dizziness, drowsiness, or lightheadedness. Do not drive or do anything else that could be dangerous until you understand how this medicine affects you.

Using this medicine while you are pregnant may lead to neonatal opioid withdrawal syndrome in your newborn. Inform your doctor immediately if your baby shows signs like an unusual sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.

This medicine may cause adrenal insufficiency. Contact your doctor right away if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Inform your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Call your doctor right away if you experience a rash, hives, itching, hoarseness, difficulty breathing or swallowing, or swelling of your hands, face, or mouth while using this medicine.

Contact your doctor immediately if you notice any changes in your heart rhythm. You might feel dizzy or faint, or experience a fast, pounding, or uneven heartbeat. Be sure your doctor knows if you or anyone in your family has had heart rhythm problems such as QT prolongation.

Do not stop using this medicine suddenly without first talking to your doctor. Your doctor may want you to gradually reduce the dose before stopping completely. This may help lessen the risk of withdrawal symptoms like anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble sleeping.

Check with your doctor immediately 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 signs of a serious condition called serotonin syndrome. Your risk may be higher if you are also taking certain other medicines that affect serotonin levels in your body.

Taking too much of this medicine may cause infertility (inability to have children). Talk to your doctor before using this medicine if you plan to have children.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medications. 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. Nevertheless, elderly patients are more likely to have age-related kidney, liver, heart, or lung issues, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Drugs

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 clinician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially important that your healthcare professional know if you are using 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 medication with any of the following drugs is not advised. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nalmefene
• Naltrexone
• Pimozide
• Piperaquine
• Posaconazole
• Safinamide
• Samidorphan
• Saquinavir
• Sparfloxacin
• Terfenadine

Using this medication with any of the following medicines is normally not advised, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medications.

• 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
• Azithromycin
• Baclofen
• Bedaquiline
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Benztropine
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bumetanide
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Carbamazepine
• Carbinoxamine
• Cariprazine
• Carisoprodol
• Carphenazine
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Chlorzoxazone
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clopamide
• Clopidogrel
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclosporine
• Cyclothiazide
• Cyproheptadine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Delorazepam
• Desipramine
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Duvelisib
• Ebastine
• Efavirenz
• Elagolix
• Eletriptan
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Eplerenone
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethacrynic Acid
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etozolin
• Etrasimod
• Etravirine
• Famotidine
• Felbamate
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flavoxate
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Frovatriptan
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Homatropine
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Ibutilide
• Idelalisib
• Iloperidone
• Imatinib
• Imipramine
• Indapamide
• Indinavir
• Inotuzumab Ozogamicin
• Ipratropium
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lapatinib
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Lenvatinib
• Lesinurad
• Letermovir
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Lurasidone
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Medazepam
• Mefloquine
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metoclopramide
• Metolazone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nafcillin
• Nalbuphine
• Naldemedine
• Naloxegol
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Palbociclib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piretanide
• Piritramide
• Pitolisant
• Polythiazide
• Ponesimod
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propafenone
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Relugolix
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Risperidone
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Schisandra sphenanthera
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spironolactone
• St John's Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Telotristat Ethyl
• Temazepam
• Terodiline
• Tetrabenazine
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Tolterodine
• Topiramate
• Toremifene
• Torsemide
• Tramadol
• Tranylcypromine
• Trazodone
• Treosulfan
• Triamterene
• Triazolam
• Trichlormethiazide
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Triptorelin
• Troleandomycin
• Tropicamide
• Trospium
• Tryptophan
• Tucatinib
• Umeclidinium
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Vortioxetine
• Voxelotor
• Xipamide
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your physician may change the dose or how often you use one or both of the medications.

• Clonidine
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medications 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 medications 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 typically not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical problems may affect the use of this medication. Make sure you inform your clinician if you have any other medical issues, especially:

• Addison disease (adrenal gland issue) or
• Alcohol abuse or dependence, or history of or
• Asthma, serious or
• Brain tumor, history of or
• Breathing problems, serious (eg, hypoxia, hypercapnia, sleep apnea) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (severe 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 issues, history of or
• Problems with passing urine or
• Stomach issues—Use with caution. May increase risk for more severe adverse 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, serious—Should not be used in patients with this condition.

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
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness
• darkening of the skin
• diarrhea
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• loss of appetite
• mental depression
• nausea
• 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
• 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.

In the U.S.

• Cassipa
• Suboxone
• Zubsolv

Available Dosage Forms:

• Tablet
• Film

Therapeutic Class: Opioid Dependency

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

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 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—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: Suboxone®: 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. Zubsolv®: 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.

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

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