How does this medication work? What will it do for me?

Buprenorphine belongs to the class of medications called opioid analgesics (pain relievers). Buprenorphine is only intended to treat persistent severe chronic (long-term) pain, when pain relief is needed around the clock and when other treatment options are no effective in controlling pain. This medication is not used to treat pain on an "as needed" basis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

75 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E0" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 75 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

150 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E1" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 150 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

300 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E3" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 300 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

450 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E4" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 450 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

600 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E6" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 600 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

750 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E7" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 750 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

900 µg
Each rectangular bi-layer, peppermint-flavoured, buccal film with rounded corners, consisting of a white to off-white backing layer with "E9" printed in black ink and a light yellow to yellow active mucoadhesive layer, contains 900 µg of buprenorphine as buprenorphine hydrochloride. Nonmedicinal ingredients: carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide and vitamin E acetate, yellow iron oxide, purified water, shellac and black iron oxide.

How should I use this medication?

The dose of buprenorphine buccal film varies depending on the individual's pain and tolerance to side effects.

For people who have not been using opioid pain relievers, the recommended starting dose is 75 µg once or twice daily. This dose can then be gradually increased until pain is controlled and side effects are tolerable.

The starting dose for people who are currently taking opioids depends on the current daily dose of opioid.

The maximum daily dose of buprenorphine is 900 µg taken every 12 hours.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Keep the medication in its pouch until you are ready to use a dose. Wet the inside of your cheek, either with your tongue or by rinsing your mouth with water.

Using a clean, dry finger, press a film in place in the inside of the cheek for 5 seconds to ensure the contact of the buccal film and the inside of the cheek is complete. The yellow side of the film should go against the cheek. Leave the film in place until it has dissolved. Do not use the buprenorphine film if it is cut or damaged in any way. Do not chew or swallow the buprenorphine film.

It usually takes less than 30 minutes for the buccal film to dissolve. Avoid eating or drinking until the film is completely dissolved. Eating or drinking before the film has completely dissolved reduces the amount of medication that is absorbed and therefore, decreases the effectiveness of the medication.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Accidental exposure to the buprenorphine film may cause death or serious medical problems. Store this medication at room temperature in a safe place, protect it from light and moisture, and keep it out of the reach and sight of children.

Do not dispose of any unneeded medication in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to buprenorphine or any ingredients of this medication
  • are dependent on opioids and experiencing narcotic withdrawal symptoms
  • are pregnant, planning to become pregnant, in labour, or breast-feeding
  • have irritation or sores in the mouth
  • have acute or severe asthma or another airway disease
  • have or are suspected to have paralytic ileus (a condition of the intestine that does not allow material to pass through the intestine) or any other conditions that block the intestine, narrow the intestine, or slow down movement through the intestinehave acute pain or pain following surgery, including outpatient surgery
  • have mild or intermittent pain that can otherwise be managed
  • have myasthenia gravis
  • have severe drowsiness or severe breathing difficulties
  • have taken MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide or selegiline) within 14 days
  • may require abdominal surgery (e.g. people with inflamed pancreas or appendix)
  • suffer from alcohol addiction or dependence, or are experiencing alcohol withdrawal
  • have  epilepsy or other conditions that can cause seizures
  • have increased intracranial pressure (increased pressure inside the head), cerebrospinal pressure (increased pressure inside the head and spine), or head injury

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • diarrhea
  • dizziness
  • dry mouth
  • headache
  • itching
  • muscle cramps
  • nausea
  • signs of low blood pressure, such as fainting, dizziness or lightheadedness, especially when standing from a lying or sitting position
  • sleepiness
  • sweating
  • tiredness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
  • symptoms of withdrawal (e.g., nausea, vomiting, diarrhea, cold, clammy skin, body aches decreased appetite, sweating)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of bowel blockage (e.g., abdominal pain, severe constipation, nausea)
  • symptoms of respiratory depression (e.g., slow, shallow or weak breathing)
  • symptoms of overdose (e.g., trouble breathing; extreme drowsiness with slowed breathing; slow, shallow breathing; feeling faint, dizzy, confused; difficulty thinking, talking, or walking; seizures; hearing, seeing, or feeling things that are not there [also known as hallucinations])

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: Like other narcotic medications, buprenorphine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have a history of abdominal problems, such as constipation or slow movement of material through the digestive system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Abnormal heart rhythms: This medication can cause an abnormal heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Accidental use: When buprenorphine is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Keep this medication out of sight and reach of children. Avoid removing the medication from its protective pouch until you are ready to use it.

Alcohol and other medications that cause drowsiness: Do not combine buprenorphine with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additive drowsiness can occur and cause serious injury or death. Tell your doctor if you are using any of these other medications.

Blood pressure: Buprenorphine can cause decreases in blood pressure, especially when a person rises from a lying or sitting position (orthostatic hypotension). To minimize the feeling of dizziness or lightheadedness upon standing, get up slowly from a lying or sitting position. If you have a condition that increases your risk of low blood pressure (hypotension) such as certain heart conditions, cerebrovascular disease (e.g., strokes), are prone to dehydration, or are being treated with blood pressure medications, discuss with your doctor how this medication may affect your medical condition or medications you are taking and whether any special monitoring is needed.

Dependence and withdrawal: As with other opioid medications, physical dependence can occur when this medication is taken for long periods of time. This is not the same as addiction. Misuse of this medication is not usually a problem when it is used appropriately to treat pain. Consult your doctor if you have any questions.

It is important to tell your doctor if you or a family member have ever been dependent on or misused alcohol, prescription medications, or street drugs.

Drowsiness/reduced alertness: Buprenorphine may impair the mental or physical abilities needed for certain potentially hazardous activities such as driving a car or operating machinery. Avoid driving or operating heavy machinery until you have determined how this medication affects you.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: If you have addiction problems, Addison's disease, blood pressure problems, enlarged prostate, problems urinating, mental health problems (e.g., depression or hallucinations), reduced pituitary function, or reduced thyroid function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mouth Sores: This medication is absorbed into the body more quickly if you have sores in your mouth, possibly resulting in an overdose. If you have mouth irritation or sores, do not use this medication.

Respiratory conditions: This medication affects breathing and may cause respiratory depression. If you experience difficulty breathing, including slow, shallow breathing, seek medical attention immediately. If you have breathing difficulties (e.g., asthma, chronic obstructive pulmonary disease [COPD], sleep apnea), are severely overweight, are taking medications that may affect breathing (e.g., codeine, morphine, oxycodone, anesthetic agents, haloperidol, phenobarbital), or are a senior, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: Buprenorphine can increase the risk of seizures, particularly if you have a seizure disorder. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Buprenorphine is not recommended for people with a seizure disorder that is being treated.

Stopping the medication: Stopping this medication suddenly may lead to withdrawal symptoms such as anxiety, sweating, difficulty sleeping, rigors, pain, nausea, tremors, diarrhea, difficulty breathing, goose bumps, or, rarely, hallucinations. If you are thinking of stopping the medication, check with your doctor first. This medication should be stopped gradually as recommended by your doctor.

Pregnancy: Taking this medication during pregnancy can harm the developing baby and cause a withdrawal syndrome in the baby after birth. Buprenorphine should not be used during pregnancy. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are using buprenorphine buccal film, it may affect your baby. Women taking this medication should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are at increased risk of experiencing side effects caused by this medication. Your doctor may recommend lower doses and increase the dose more gradually to avoid unnecessary side effects.

What other drugs could interact with this medication?

There may be an interaction between buprenorphine and any of the following:

  • aclidinium
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aprepitant
  • atropine
  • azelastine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, pentobarbital phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • bosentan
  • brimonidine
  • bromocriptine
  • buspirone
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • chloral hydrate
  • clondidne
  • cobicistat
  • conivaptan
  • dabrafenib
  • deferasirox
  • desmopressin
  • dextromethorphan
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dofetilide
  • domperidone
  • dronedarone
  • entacapone
  • enzalutamide
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • flavoxate
  • general anesthetics (medications used to put people to sleep before surgery)
  • glycopyrrolate
  • grapefruit juice
  • guanfacine
  • hepatitis C antivirals s (e.g., daclatasvir, dasabuvir, ombitasvir, paritaprevir, ritonavir, simeprevir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • idelalisib
  • ipratropium
  • kava kava
  • ketotifen
  • linezolid
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • metoclopramide
  • mifepristone
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
  • nabilone
  • naltrexone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • norfloxacin
  • octreotide
  • oxybutynin
  • pegvisomant
  • pramipexole
  • protein kinase inhibitors (e.g., crizotinib, imatinib, nilotinib, vemurafenib)
  • quinidine
  • quinine
  • rifampin
  • ropinirole
  • rotigotine
  • rufinamide
  • St. John's wort
  • sarilumab
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • siltuximab
  • solifenacin
  • sotalol
  • tetracycline
  • thalidomide
  • tocilizumab
  • tiotropium
  • tolcapone
  • tolterodine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)
  • "triptan" migraine medications (e.g., eletriptan, rizatriptan, sumatriptan)
  • tryptophan
  • umeclidinium
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Belbuca