Buprenorphine Buccal (chronic pain)

Name: Buprenorphine Buccal (chronic pain)

Why is this medication prescribed?

Buprenorphine (Belbuca) is used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Buprenorphine (Belbuca) should not be used to treat pain that can be controlled by medication that is taken as needed. Buprenorphine (Belbuca) in a class of medications called opiate partial agonists. It works by changing the way the brain and nervous system respond to pain.

What special precautions should I follow?

Before using buprenorphine (Belbuca),

  • tell your doctor and pharmacist if you are allergic to buprenorphine, any other medications, or any of the ingredients in buprenorphine buccal films. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Nexterone, Pacerone); anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine); butorphanol; carbamazepine (Carbatrol, Tegretol, Teril, others); clarithromycin (Biaxin, in Prevpac); cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); disopyramide (Norpace); diuretics ('water pills'); dofetilide (Tikosyn); enzalutamide (Xtandi); human immunodeficiency virus (HIV) medications such as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; nefazodone; pentazocine (Talwin); phenobarbital; phenytoin (Dilantin, Phenytek); pioglitazone (Actos); procainamide; quinidine (in Nuedexta); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); tramadol (Conzip, Ultram, in Ultracet); trazodone ; sotalol (Betapace, Sotylize, others); or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with buprenorphine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
  • tell your doctor if you have any of the conditions listed in the IMPORTANT WARNING section or paralytic ileus (condition in which food does not move through the intestines) or a blockage in the stomach or intestines. Your doctor may tell you not to use buprenorphine (Belbuca).
  • tell your doctor if you or an immediate family member have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death); if you have low levels of potassium or magnesium in the blood; and if you have or have ever had a slow or irregular heartbeat; heart failure; low blood pressure; any condition that causes difficulty urinating; seizures; mouth sores; or gallbladder, pancreas, kidney, thyroid, or liver disease.
  • tell your doctor if you are breastfeeding.
  • you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using buprenorphine (Belbuca).
  • you should know that buprenorphine (Belbuca) may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that buprenorphine (Belbuca) may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that buprenorphine (Belbuca) may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine (Belbuca).

What should I do if I forget a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • slowed or difficulty breathing
  • extreme sleepiness or drowsiness
  • coma (loss of consciousness for a period of time)
  • slow heartbeat
  • cold, clammy skin
  • muscle weakness
  • narrowing or widening of the pupils (black circles in the center of the eye)
  • unusual snoring

What other information should I know?

Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to buprenorphine.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine.

Do not let anyone else take your medication. Buprenorphine (Belbuca) is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Belbuca®
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