Buprenorphine (bue-pre-NOR-feen)

Treats addiction to opioid pain relievers. Also relieves severe pain.

Brand Name(s):

Belbuca

When This Medicine Should Not Be Used:

How to Use This Medicine:

Thin Sheet, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may give naloxone to treat an overdose.
• Buccal film:
  • Do not place a film on an area of the mouth that has sores or lesions.
  • Use your tongue to wet the side of your cheek or rinse your mouth with water.
  • Place the yellow side of the film against the inside of your cheek.
  • Press down on the film and hold it in place with clean, dry fingers for 5 seconds.
  • Leave the film in place until it dissolves. Do not touch or move the it. Do not chew or swallow the film.
  • Do not eat or drink anything until the film is completely dissolved, which is usually within 30 minutes.
  • Rinse your mouth with water and swallow. Wait for at least one hour before brushing your teeth.
  • Do not use a film that is cut, torn, or damaged.
• Sublingual tablet:
  • Do not cut, crush, chew, or swallow it.
  • Place the tablet under the tongue until it is dissolved.
  • If you take more than 2 tablets at a time, place all of the tablets in different places under the tongue at the same time.
  • If you cannot fit more than 2 tablets under your tongue comfortably, place 2 at a time until you have taken all of the medicine.
  • Do not eat or drink anything until the tablets are completely dissolved.
  • Take a sip of water, swish gently swish around your mouth, and swallow. Wait at least one hour before brushing your teeth.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid 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

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor (MAOI) within the past 14 days.
• Some medicines can affect how buprenorphine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, tramadol, trazodone
  • Diuretic (water pill)
  • Medicine to treat anxiety, mental health, or depression (including SNRIs, SSRIs, TCAs)
  • Medicine to treat heart rhythm problems (including amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol)
  • Medicine to treat HIV or AIDS medicine (including atazanavir, delavirdine, efavirenz, etravirine, nevirapine, ritonavir)
  • Phenothiazine medicine
  • Tranquilizer or benzodiazepine medicine (including alprazolam, clonazepam, diazepam, lorazepam)
  • Triptan or medicine to treat migraine headaches
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer (including cyclobenzaprine, metaxalone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, an adrenal gland problem, an enlarged prostate, gallbladder problems, lung or breathing problems (including COPD, sleep apnea), tooth problems (including history of cavities), mouth sores or ulcers, pancreas problems, trouble urinating, an underactive thyroid, or mental health problems (including depression). Tell your doctor if you have heart disease, congestive heart failure, a slow heartbeat, or a history of heart rhythm problems (including long QT syndrome). Tell your doctor if you have ever had a head injury, brain tumor, seizures, stroke, or alcohol or drug use disorder.
• This medicine may cause the following problems:
  • High risk of an overdose, which can lead to death
  • Respiratory depression (serious breathing problem which can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • Adrenal gland problems
  • QT prolongation (heart rhythm problem)
  • Tooth problems (including tooth fracture, tooth loss)
  • Low blood pressure
  • Liver problems
  • Serotonin syndrome, when used with certain medicines
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Tell any doctor or dentist who treats you that you are using this medicine.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness or weakness, shallow breathing, sweating, seizures, cold or clammy skin
• Fast, pounding, or uneven heartbeat
• Severe confusion, lightheadedness, dizziness, or fainting
• Severe constipation
• Trouble breathing or slow breathing
• Toothache
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild constipation
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

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