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BUPRENORPHINE AND NALOXONE- buprenorphine hydrochloride, naloxone hydrochloride film, soluble


  1. Patient Information
  2. What Is Buprenorphine And Naloxone Sublingual Film?
  3. Who Should Not Take Buprenorphine And Naloxone Sublingual Film?
  4. Buprenorphine And Naloxone Sublingual Film May Not Be Right For You. Before Taking Buprenorphine And Naloxone Sublingual Film, Tell Your Doctor If You:
  5. Buprenorphine And Naloxone Sublingual Film Can Cause Serious Side Effects, Including:
  6. How Should I Dispose Of Unused Buprenorphine And Naloxone Sublingual Film?
  7. Active Ingredients:
  8. Inactive Ingredients:
  9. Revised: 4/2019document Id:

Patient Information 

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Safe Use

Before initiating treatment with buprenorphine and naloxone sublingual film, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time buprenorphine and naloxone sublingual film is dispensed because new information may be available.

  • Buprenorphine and naloxone sublingual film must be administered whole. Advise patients not to cut, chew, or swallow buprenorphine and naloxone sublingual film.
  • Inform patients and caregivers that potentially fatal additive effects may occur if buprenorphine and naloxone sublingual film is used with benzodiazepines or other CNS depressants, including alcohol. Counsel patients that such medications should not be used concomitantly unless supervised by a health care provider[

    • Buprenorphine and naloxone sublingual film can cause serious and life threatening breathing problems. Call your doctor right away or get emergency help if:
      • You feel faint, dizzy, or confused
      • Your breathing gets much slower than is normal for youThese can be signs of an overdose or other serious problems.
    • Do not switch from buprenorphine and naloxone sublingual film to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine and naloxone sublingual film that may be different than other buprenorphine containing medicines you may have been taking.
    • Buprenorphine and naloxone sublingual film contains an opioid that can cause physical dependence.
      • Do not stop taking buprenorphine and naloxone sublingual film without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
      • Physical dependence is not the same as drug addiction.
      • Buprenorphine and naloxone sublingual film is not for occasional or as needed use.
    • An overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using buprenorphine and naloxone sublingual film. Ask your doctor what you should do if you are taking one of these.
    • Call a doctor or get emergency help right away if you:
      • Feel sleepy and uncoordinated
      • Have blurred vision
      • Have slurred speech
      • Cannot think well or clearly
      • Have slowed reflexes and breathing
    • Do not inject ( shoot up ) buprenorphine and naloxone sublingual film.
      • Injecting buprenorphine and naloxone sublingual film may cause life threatening infections and other serious health problems.
      • Injecting buprenorphine and naloxone sublingual film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
    • In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with buprenorphine and naloxone sublingual film.

What Is Buprenorphine And Naloxone Sublingual Film? 


  • Buprenorphine and naloxone sublingual film is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
  • Buprenorphine and naloxone sublingual film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your buprenorphine and naloxone sublingual film in a safe place to protect it from theft. Never give your buprenorphine and naloxone sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law. It is not known if buprenorphine and naloxone sublingual film is safe or effective in children.

Who Should Not Take Buprenorphine And Naloxone Sublingual Film? 


Do not take buprenorphine and naloxone sublingual filmif you are allergic to buprenorphine or naloxone.

Buprenorphine And Naloxone Sublingual Film May Not Be Right For You. Before Taking Buprenorphine And Naloxone Sublingual Film, Tell Your Doctor If You: 


  • Have liver or kidney problems
  • Have trouble breathing or lung problems
  • Have an enlarged prostate gland (men)
  • Have a head injury or brain problem
  • Have problems urinating
  • Have a curve in your spine that affects your breathing
  • Have gallbladder problems
  • Have adrenal gland problems
  • Have Addison's disease
  • Have low thyroid (hypothyroidism)
  • Have a history of alcoholism
  • Have mental problems such as hallucinations (
    • Always take buprenorphine and naloxone sublingual film exactly as your doctor tells you. Your doctor may change your dose after
      • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you.Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take buprenorphine and naloxone sublingual film.
      • You should not drink alcohol while using buprenorphine and naloxone sublingual film,as this can lead to loss of consciousness or even death.

Buprenorphine And Naloxone Sublingual Film Can Cause Serious Side Effects, Including: 


  • Store buprenorphine and naloxone sublingual film at room temperature between 68 F to 77 F (20 C to 25 C).
    Keep buprenorphine and naloxone sublingual film in a safe place, out of the sight and reach of children.
  • How Should I Dispose Of Unused Buprenorphine And Naloxone Sublingual Film? 


    • Dispose of unused buprenorphine and naloxone sublingual film as soon as you no longer need them.
    • Unused films should be removed from the foil pouch and flushed down the toilet.
    • Do not flush the buprenorphine and naloxone sublingual film foil pouch down the toilet.If you need help with disposal of buprenorphine and naloxone sublingual film, call 1 877 782 6966.
    General information about the safe and effective use of buprenorphine and naloxone sublingual film.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take buprenorphine and naloxone sublingual film for a condition for which it was not prescribed. Do not give buprenorphine and naloxone sublingual film to other people, even if they have the same symptoms you have. It may harm them and it is against the law.
    This Medication Guide summarizes the most important information about buprenorphine and naloxone sublingual film. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.
    For more information, call 1 877 782 6966.

    Active Ingredients: 

    buprenorphine and naloxone.

    Inactive Ingredients: 

    polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.
    Manufactured for Sandoz Inc. Princeton, NJ 08540 by: Aquestive Therapeutics, Warren, NJ 07059

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 2 mg/0.5 mg Carton Label

    NDC 0781-7216-64

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    2 mg/0.5 mg

    Rx only

    30 Pouches each containing 1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 2 mg/0.5 mg Carton Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 2 mg/0.5 mg Pouch Label

    NDC 0781-7216-06

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    2 mg/0.5 mg

    Rx only

    1 Sublingual Film

    SANDOZ

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 2 mg/0.5 mg Pouch Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 4 mg/1 mg Carton Label

    NDC 0781-7227-64

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    4 mg/1 mg

    Rx only

    30 Pouches each containing 1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 4 mg/1 mg Carton Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 4 mg/1 mg Pouch Label

    NDC 0781-7227-06

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    4 mg/1 mg

    Rx only

    1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 4 mg/1 mg Pouch Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 8 mg/2 mg Carton Label

    NDC 0781-7238-64

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    8 mg/2 mg

    Rx only

    30 Pouches each containing 1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 8 mg/2 mg Carton Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 8 mg/2 mg Pouch Label

    NDC 0781-7238-06

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    8 mg/2 mg

    Rx only

    1 Sublingual Film

    SANDOZ

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 8 mg/2 mg Pouch Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 12 mg/3 mg Carton Label

    NDC 0781-7249-64

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    12 mg/3 mg

    Rx only

    30 Pouches each containing 1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 12 mg/3 mg Carton Label

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 12 mg/3 mg Pouch Label

    NDC 0781-7249-06

    Buprenorphine and
    Naloxone Sublingual Film

    CIII

    12 mg/3 mg

    Rx only

    1 Sublingual Film

    SANDOZ

    a Novartis company

    Principal Display Panel - Buprenorphine and Naloxone Sublingual Film 12 mg/3 mg Pouch Label
    BUPRENORPHINE AND NALOXONE
    buprenorphine hydrochloride, naloxone hydrochloride film, soluble
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-7216
    Route of AdministrationSUBLINGUAL, BUCCALDEA ScheduleCIII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)buprenorphine2 mg
    naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N)naloxone0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
    HYPROMELLOSES(UNII: 3NXW29V3WO)
    maltitol(UNII: D65DG142WK)
    acesulfame potassium(UNII: 23OV73Q5G9)
    citric acid monohydrate(UNII: 2968PHW8QP)
    sodium citrate(UNII: 1Q73Q2JULR)
    FD&C yellow no. 6(UNII: H77VEI93A8)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0781-7216-6430 in 1 CARTON02/19/2019
    1NDC:0781-7216-061 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02241002/19/2019
    BUPRENORPHINE AND NALOXONE
    buprenorphine hydrochloride, naloxone hydrochloride film, soluble
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-7227
    Route of AdministrationSUBLINGUAL, BUCCALDEA ScheduleCIII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)buprenorphine4 mg
    naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N)naloxone1 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
    HYPROMELLOSES(UNII: 3NXW29V3WO)
    maltitol(UNII: D65DG142WK)
    acesulfame potassium(UNII: 23OV73Q5G9)
    citric acid monohydrate(UNII: 2968PHW8QP)
    sodium citrate(UNII: 1Q73Q2JULR)
    FD&C yellow no. 6(UNII: H77VEI93A8)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0781-7227-6430 in 1 CARTON02/19/2019
    1NDC:0781-7227-061 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02241002/19/2019
    BUPRENORPHINE AND NALOXONE
    buprenorphine hydrochloride, naloxone hydrochloride film, soluble
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-7238
    Route of AdministrationSUBLINGUAL, BUCCALDEA ScheduleCIII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)buprenorphine8 mg
    naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N)naloxone2 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
    HYPROMELLOSES(UNII: 3NXW29V3WO)
    maltitol(UNII: D65DG142WK)
    acesulfame potassium(UNII: 23OV73Q5G9)
    citric acid monohydrate(UNII: 2968PHW8QP)
    sodium citrate(UNII: 1Q73Q2JULR)
    FD&C yellow no. 6(UNII: H77VEI93A8)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0781-7238-6430 in 1 CARTON02/19/2019
    1NDC:0781-7238-061 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02241002/19/2019
    BUPRENORPHINE AND NALOXONE
    buprenorphine hydrochloride, naloxone hydrochloride film, soluble
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-7249
    Route of AdministrationSUBLINGUAL, BUCCALDEA ScheduleCIII
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)buprenorphine12 mg
    naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N)naloxone3 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
    HYPROMELLOSES(UNII: 3NXW29V3WO)
    maltitol(UNII: D65DG142WK)
    acesulfame potassium(UNII: 23OV73Q5G9)
    citric acid monohydrate(UNII: 2968PHW8QP)
    sodium citrate(UNII: 1Q73Q2JULR)
    FD&C yellow no. 6(UNII: H77VEI93A8)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0781-7249-6430 in 1 CARTON02/19/2019
    1NDC:0781-7249-061 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02241002/19/2019
    Labeler -Sandoz Inc (110342024)

    Revised: 4/2019document Id: 

    b4c1273d-cd04-4160-8366-26c185e708f2Set id: 16695a4c-9e32-4a4d-8aa9-e10fd2412a46Version: 6Effective Time: 20190425Sandoz Inc



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