Mylan-Buprenorphine/Naloxone

Brand Name

Mylan-Buprenorphine/Naloxone

Common Name

buprenorphine - naloxone

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

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

This combination medication contains two active ingredients: buprenorphine and naloxone.

Buprenorphine belongs to a group of medications known as partial opiate agonists.

Naloxone belongs to a group of medications known as opiate antagonists.

The combination medication is used, together with an overall addiction treatment program that includes medical, social, and psychological support, to treat adults who are dependent on opiates (narcotics) such as oxycodone or morphine. A person addicted to narcotics who suddenly stops taking the narcotic may experience severe withdrawal symptoms.

Buprenorphine works by replacing the physical effects of the narcotic the person is addicted to, which can help make it easier to treat their addiction. Naloxone is added to the medication to prevent it from being misused (i.e., to prevent it from being injected into a vein). Naloxone has no effect if given under the tongue as the medication is intended. But if the medication is misused and injected into a vein (also called "shooting up"), naloxone will work by blocking the effects of buprenorphine, leading to withdrawal symptoms.

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 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. Do not stop taking this medication without consulting your doctor.

How should I use this medication?

This medication must be prescribed by a qualified doctor who meets specific requirements regarding the use of the medication. The dose of this medication varies depending on the individual situation and will be adjusted by your doctor.

The usual recommended starting dose is 2 mg to 4 mg (of buprenorphine). Your doctor will gradually adjust the dose until you are no longer experiencing the effects of narcotic withdrawal. The maximum daily dose is 24 mg. Over time, your doctor may gradually decrease your dose until the medication has been stopped. Do not try to adjust the dose or stop the medication on your own.

Buprenorphine – naloxone is taken once daily. Do not cut, break, crush, or chew this medication. Taking this medication in any other way than prescribed can cause serious harm, death, or unpleasant withdrawal effects.

[Sublingual Tablets]

The medication should be placed under the tongue until it has dissolved (this usually happens within 2 to 10 minutes). Do not swallow the tablets. Do not cut, break, crush, or chew the tablets. If more than one tablet is needed at a time, both tablets may be placed under the tongue at the same time. Alternatively, you may place one tablet under the tongue at a time, placing the second tablet under the tongue immediately after the first tablet has dissolved. Avoid eating or drinking until the tablet is completely dissolved.

Do not stop taking this medication on your own. Your doctor will advise you on how to taper the medication to avoid withdrawal symptoms, when it is time to stop using buprenorphine - naloxone.

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.

It is important to use this medication exactly as prescribed by your doctor. If you miss a single dose, take it as soon as possible. If you have missed more than one dose, contact your doctor or pharmacist for instructions. Do not take a double dose to make up for a missed dose.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the sight and reach of children. Accidental use by a child is a medical emergency and may result in death.

[Sublingual Film]

Buprenorphine – naloxone is taken once daily. The sublingual film should be left in the original foil packaging until you are ready to take the medication. When you are ready to use a dose, take a sip of water to moisten your mouth. Remove the film from the foil package with dry hands, holding it by the edges. Place the film under the tongue and allow it to dissolve. Do not eat or drink anything until the film has dissolved completely. If you are using 2 films you can place one under each side of the tongue. If your doctor tells you that you need a third film, place it under your tongue on either side after the first 2 films have dissolved. Do not use more than 2 films at the same time.

Once you are on a steady dose of buprenorphine – naloxone film, as an alternative, they may be dissolved by placing the film in the cheek. If you are using 2 films you can place one on the inside of each cheek. If your doctor tells you that you need a third film, place it inside one of your cheeks after the first 2 films have dissolved. Do not use more than 2 films at the same time.

Do not stop taking this medication on your own. Your doctor will advise you on how to taper the medication to avoid withdrawal symptoms, when it is time to stop using buprenorphine - naloxone.

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.

It is important to use this medication exactly as prescribed by your doctor. If you miss a single dose, take it as soon as possible. If you have missed more than one dose, contact your doctor or pharmacist for instructions. Do not take a double dose to make up for a missed dose.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the sight and reach of children. Accidental use by a child is a medical emergency and may result in death.

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.

What form(s) does this medication come in?

2 mg/0.5 mg
Each white-to-off-white, 0.2500 inch round, flat-faced, bevelled-edged tablet debossed with "M" inside a hexagon on one side of the tablet and "2-5" on the other side contains 2 mg of buprenorphine and 0.5 mg of naloxone. Nonmedicinal ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, crospovidone, lactose monohydrate, lemon lime flavour, magnesium stearate, mannitol, and sodium citrate.

8 mg/2 mg
Each white-to-off-white, 0.4062 inch round, flat-faced, bevelled-edged tablet debossed with "M" inside a hexagon on one side of the tablet and "8-2" on the other side contains 8 mg of buprenorphine and 2 mg of naloxone. Nonmedicinal ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, crospovidone, lactose monohydrate, lemon lime flavour, magnesium stearate, mannitol, and sodium citrate.

Who should NOT take this medication?

Do not take buprenorphine - naloxone if you:

• are allergic to buprenorphine, naloxone, or any ingredients of the medication
• have acute alcohol addiction
• have delirium tremens
• have not been taking opioid pain relievers regularly
• have severely reduced liver function
• have severely reduced lung (breathing) function
• are currently taking or have taken a MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 14 days
• have a blockage in the digestive system or slowed movement of your digestive system
• are experiencing sudden, severe, abdominal pain that may require surgery (surgical abdomen)
• 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 a 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 ability or interest in sexual activity
• dizziness when getting up from a sitting or lying position
• dry mouth
• headache
• itching
• loss of appetite
• mouth irritation
• nausea
• stomach pain
• sweating
• tiredness or drowsiness
• trouble sleeping
• 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:

• chest pain
• confusion
• fast, slow, or irregular heartbeat
• hallucinations (seeing or hearing things that are not really there)
• skin rash, hives
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• symptoms of blocked bowel (e.g., abdominal pain, nausea, severe constipation)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of liver problems (such as yellow eyes or skin, abdominal pain, loss of appetite, pale stools, itchy skin, or dark urine)
• symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
• vision changes
• weakness

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

• feeling faint, dizzy, confused, or having any unusual symptoms
• seizures
• signs of overdose (e.g., cold, damp skin; confusion; shakiness; nausea; weak, rapid pulse; inability to walk normally; breathing difficulty; floppy muscles)
• slower than normal breathing or difficulty breathing
• symptoms of a serious allergic reaction (such as swelling of the face or throat, skin rash, hives, wheezing, or difficulty breathing)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

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: As with other narcotic medications, buprenorphine - naloxone may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal 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.

Accidental use: When buprenorphine - naloxone 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 blister until you are ready to use the tablet.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and avoid combining it with other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness. Doing so can cause additive drowsiness and reduced breathing as well as other side effects, which can be dangerous. It is not recommended for people with alcohol abuse problems.

Breathing: Buprenorphine - naloxone can cause serious and life-threatening breathing problems. This effect on breathing may be more pronounced for people with breathing problems or brain damage, or those who are taking other medications that suppress breathing (e.g., codeine, morphine). If you have breathing problems, such as COPD, asthma, or respiratory depression, 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.

Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with this medication. Severe withdrawal symptoms may be experienced (e.g., seizures) if the dose is significantly reduced or suddenly stopped. Withdrawal symptoms include irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

Drowsiness/reduced alertness: This medication causes drowsiness or reduced alertness. Do not drive or engage in other activities requiring alertness unless and until you know how the medication affects you. Alcohol and antianxiety medications can increase the drowsiness caused by this medication.

Drug testing for sports: This medication may cause a positive result on anti-doping tests.

Head injury: Buprenorphine - naloxone can cause increased pressure inside the head. If you have acute head injuries or other conditions which increase your intracranial pressure (pressure inside the head), 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.

Kidney function: If you have reduced kidney function or kidney disease, 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.

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, such as hepatitis C, alcohol abuse or anorexia, 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.

This medication may also cause injury to the liver, particularly if it is misused. 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.

Low blood pressure: Buprenorphine - naloxone can cause low blood pressure or make low blood pressure worse. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

Medical conditions: Tell your doctor if you have any of the following conditions:

• Addison's disease
• an enlarged prostate or other problems with urination
• a problem with brain health
• a problem with spinal curvature that affects breathing
• an underactive thyroid

This medication may cause a change in the symptoms of any of these medical conditions. For this reason, it is important to be closely monitored by your doctor while you are taking buprenorphine - naloxone.

Misuse of the medication: Do not misuse this medication by injecting it, as this could cause serious effects such as trouble breathing, severe infections, skin reactions, or death from overdose. Do not give this medication to anyone else. It can be harmful for people to take this medication if their doctor has not prescribed it.

Serotonin Syndrome: Severe reactions are possible when buprenorphine - naloxone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, 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.

Stopping the medication: This medication can cause withdrawal symptoms if it is stopped too quickly. Do not stop this medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. If it is taken near the end of pregnancy, the baby may experience withdrawal syndrome after being born.

Breast-feeding: Buprenorphine passes into breast milk. It is not known if naloxone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding is not recommended for women who are taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children. If this medication is taken accidentally by a child, it is a medical emergency and may be fatal.

Seniors: The safety and effectiveness of using this medication have not been established for people over the age of 65 years. Buprenorphine - naloxone should be used with caution in this age group.

What other drugs could interact with this medication?

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

• aclidinium
• alcohol
• amiodarone
• amphetamines (e.g., lisdexamfetamine, dexamphetamine)
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apalutamide
• aprepitant
• atropine
• azelastine
• azole antifungals (e.g., ketoconazole, fluconazole, itraconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• belladonna
• benzodiazepines (e.g., lorazepam, diazepam)
• benztropine
• bosentan
• brimonidine
• buspirone
• butorphanol
• cannabis
• chloral hydrate
• clidinium
• clonidine
• cobicistat
• conivaptan
• darifenacin
• desmopressin
• diltiazem
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• domperidone
• dronedarone
• eluxadoline
• entacapone
• enzalutamide
• eszopiclone
• flibanserin
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• glycopyrronium
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (e.g., darunavir, efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• ipratropium
• kava kava
• ketotifen
• lemborexant
• linezolid
• lithium
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• methadone
• methylnaltrexone
• metoclopramide
• mifepristone
• mirtazapine
• mitotane
• modafinil
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
• nabilone
• naloxegol
• naltrexone
• octreotide
• other opiates (narcotics; e.g., codeine, morphine, hydromorphone, oxycodone, tramadol, tapentadol)
• oxybutynin
• pegvisomant
• pomalidomide
• pramipexole
• procainamide
• certain protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, imatinib)
• quinidine
• quinine
• rifabutin
• rifampin
• ropinirole
• rotigotine
• St. John's wort
• sarilumab
• scopolamine
• seizure medications (e.g., clobazam, carbamazepine, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, rufinamide, 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
• thalidomide
• tiotropium
• tocilizumab
• tolterodine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• trospium
• tryptophan
• umeclidinium
• verapamil
• 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 – 2025. 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/Mylan-BuprenorphineNaloxone