This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat narcotic (opioid) dependence/addiction. Buprenorphine belongs to a class of drugs called mixed narcotic agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opiate-type narcotics.
Naloxone is a narcotic antagonist that blocks the effect of narcotics and can cause severe narcotic withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth or dissolved under the tongue. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Use this medication as directed by your doctor, usually once daily. Drink some water to moisten your mouth before use. This helps the film dissolve. With dry hands, open the foil packet just before use and place the medication film under your tongue. Keep the film in place until it completely dissolves. Do not talk, swallow, chew, or move the film after placing it under your tongue, or it will not work as well.
If you are prescribed more than one film each day, place the second film under your tongue on the opposite side of the mouth. Try not to have the films touch each other. If your doctor has prescribed a third film, place it under your tongue after the first 2 films have completely dissolved.
Buprenorphine alone may be used instead of this medication for the first 2 days after you have stopped all other narcotics. It is usually given in your doctor's office. Your doctor will then switch you to this combination buprenorphine/naloxone medication for maintenance treatment.
The dosage is based on your medical condition and response to treatment. Your doctor will adjust the dose until there are no symptoms of withdrawal. Do not switch between sublingual tablets and film, because you may need a different dose if you switch. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop the medication when directed.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as diarrhea, restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Do not inject ("shoot up") buprenorphine/naloxone. Injecting it is dangerous, and will likely cause severe withdrawal symptoms due to the naloxone in this medication, especially if you have been using narcotics such as heroin, morphine or methadone.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get medical help right away.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Although this medication is used to prevent withdrawal reactions, it may rarely cause narcotic withdrawal symptoms (see also How to Use section). This is more likely to happen when you first start treatment or if you have been using long-acting narcotics such as methadone. If such symptoms occur, tell your doctor or pharmacist right away.
Severe (possibly fatal) breathing problems can occur, especially if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other narcotics).
Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, severe dizziness, mental/mood changes (such as agitation, confusion, hallucinations), slow/shallow breathing, unusual drowsiness/difficulty waking up.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to buprenorphine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol increases your risk for serious, possibly fatal, breathing problems.
Buprenorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using buprenorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using buprenorphine safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness, slow/shallow breathing, and QT prolongation (see above).
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
Buprenorphine passes into breast milk. It is unknown if naloxone passes into breast milk. This product may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this medication include: narcotic antagonists (such as naltrexone), certain narcotic pain medications (mixed narcotic agonist-antagonists such as butorphanol, nalbuphine, pentazocine).
Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), including amiodarone, bretylium, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, among others.
Other medications can affect the removal of buprenorphine from your body, which may affect how buprenorphine works. Examples include azole antifungals (such as ketoconazole), HIV protease inhibitors (such as atazanavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness, dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotics (such as hydrocodone, oxycodone), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Deaths have occurred when this medication has been misused by injecting it ("shooting up"), especially when used in combination with benzodiazepines (such as diazepam) or other depressants such as alcohol or additional narcotics.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.
Do not share this medication with others. It is against the law.
Tell all of your doctors that you use this medication and have regularly used narcotics, especially in cases of emergency treatment.
Laboratory and/or medical tests (such as liver function tests, urine drug screening) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store in a secure place at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Properly discard this product when it is expired or no longer needed. To discard this medication, the FDA recommends flushing down the toilet or pouring into a drain. However, consult your pharmacist or local waste disposal company.
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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