Buprenorphine & Naloxone

Buprenorphine and naloxone are prescription medications used for the maintenance treatment of opioid addiction in adults. This combination is available as a single product containing 2 medications.

Buprenorphine and naloxone belong to a group of drugs called opioid antagonists. These work by preventing withdrawal symptoms when someone stops taking opioid medications.

This medication is available as a film that is applied to the buccal mucosa (the inside lining of the cheek) once daily. It is also available as a film and a tablet that are applied sublingually (under the tongue). Avoid eating or drinking until the film or tablet has dissolved entirely.

Common side effects of buprenorphine and naloxone include headache, nausea, vomiting, excessive sweating, constipation, opioid withdrawal symptoms, insomnia, and pain.

Buprenorphine and naloxone can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how buprenorphine and naloxone affect you.

Buprenorphine and naloxone are available in a combination prescription medication that is used for maintenance treatment of opioid addiction. This combination is used to prevent withdrawal symptoms when someone stops taking opioid medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The dose of buprenorphine and naloxone should be increased slowly until reaching a level that maintains the patient’s treatment and suppresses signs and symptoms of opioid withdrawal.

Serious side effects have been reported with buprenorphine and naloxone including the following:

• Respiratory problems. You have a higher risk of death and coma from respiratory problems if you take buprenorphine and naloxone with other medicines that cause respiratory problems, such as benzodiazepines including diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien).
• Sleepiness, dizziness, and problems with coordination
• Decreased blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• Dependency or abuse
• Liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems:
• Yellowing of the skin or eyes
• Dark urine
• Light colored stools
• Decreased appetite
• Stomach pain
• Allergic reaction. Tell your doctor right away if you have any of the following signs or symptoms of an allergic reaction:
  • Rash
  • Hives
  • Swelling of the face
  • Wheezing
  • Decreased blood pressure
  • Loss of consciousness
• Opioid withdrawal. Symptoms of opioid withdrawal may include:
  • Shaking
  • Excessive sweating
  • Feeling hot or cold more than normal
  • Runny nose
  • Watery eyes
  • Goosebumps
  • Diarrhea
  • Vomiting
  • Muscle aches

Buprenorphine and naloxone can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how buprenorphine and naloxone affect you.

Do not take buprenorphine and naloxone if you:

• are allergic to buprenorphine and naloxone or to any of the ingredients in the combination product

Serious side effects have been reported with buprenorphine and naloxone. See the “Buprenorphine and naloxone Precautions” section.

Common side effects of buprenorphine and naloxone include the following:

• headache
• nausea
• vomiting
• excessive sweating
• constipation
• opioid withdrawal symptoms
• insomnia
• pain
• mouth numbness
• tongue pain
• lightheadedness
• irregular heartbeat
• fainting

This is not a complete list of buprenorphine and naloxone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen (Tylenol, others)
• antifungals such as fluconazole (Diflucan), itraconazole (Sporanox) and ketoconazole (Nizoral)
• benzodiazepines such as diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien)
• carbamazepine (Tegretol)
• cholesterol-lowering medications (statins)
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• dexamethasone (Decadron)
• diltiazem (Cardizem, Dilacor, Tiazac)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• ethosuximide (Zarontin)
• fluoxetine (Prozac, Sarafem)
• fluvoxamine (Luvox)
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir)
• iron products
• isoniazid (INH, Nydrazid)
• medications for anxiety, mental illness, and seizures
• methotrexate (Rheumatrex)
• metronidazole (Flagyl)
• nefazodone (Serzone)
• niacin (nicotinic acid)
• oral contraceptives (birth control pills)
• phenobarbital (Luminal)
• phenytoin (Dilantin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• troleandomycin 
• verapamil (Calan, Covera, Isoptin, Verelan)
• zafirlukast (Accolate)

This is not a complete list of buprenorphine and naloxone drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Buprenorphine and naloxone fall into category C. There are no well-controlled studies that have been done in pregnant women. Buprenorphine and naloxone should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Buprenorphine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from buprenorphine and naloxone, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.