Brand Name Mylan-Buprenorphine/Naloxone Common Name buprenorphine - naloxone
The content of this page:
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.
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 4 mg to 8 mg (of buprenorphine) once daily. Your doctor will 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.
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. 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.
Buprenorphine - naloxone is used for a minimum of 2 months. 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.
What form(s) does this medication come in?
2 mg/0.5 mg
Each white-to-off-white, 0.2500" round, flat-faced, bevelled-edge tablet debossed with "M" inside a hexagon on one side of the tablet and "2-5" on the other side. 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" round, flat-faced, bevelled-edge tablet debossed with "M" inside a hexagon on one side of the tablet and "8-2" on the other side. 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
- are breast-feeding
- 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
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.
- dizziness when getting up from a sitting or lying position
- loss of appetite
- stomach pain
- tiredness or drowsiness
- trouble sleeping
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:
- decreased blood pressure
- 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)
- swelling hands or feet
- 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 sugar (e.g., cold sweat, cool pale skin, headache, fast heart beat, weakness)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- chest pain
- feeling faint, dizzy, confused, or having any unusual symptoms
- 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)
Are there any other precautions or warnings for 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.
Alcohol use: People taking this medication should not consume alcohol since doing so can reduce the effectiveness of this medication and increase the risk of side effects. It is not recommended for people with alcohol abuse problems.
Breathing: Buprenorphine - naloxone can suppress breathing. 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.
Medical conditions: Tell your doctor if you have any of the following conditions:
- Addison's disease
- an enlarged prostate or other problems with urination
- low blood pressure
- 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.
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:
- abiraterone acetate
- amphetamines (e.g., lisdexamphetamine, dexamphetamine)
- antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol,olanzapine, quetiapine, risperidone)
- azole antifungals (e.g., ketoconazole, itraconazole)
- barbiturates (e.g., butalbital, phenobarbital)
- benzodiazepines (e.g., lorazepam, diazepam)
- calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
- chloral hydrate
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- general anesthetics (medications used to put people to sleep before surgery)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (e.g., delaviridine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- kava kava
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- other opiates (narcotics; e.g., codeine, morphine, hydromorphone, oxycodone)
- certain protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib)
- St. John's wort
- seizure medications (e.g., clobazam, carbamazepine, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
- sodium oxybate
- tricyclic antidepressants (e.g., amitriptyline, imipramine)
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.
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 – 2018. 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