Bunavail

Bunavail is a prescription medication used for maintenance treatment of opioid addiction. It is a single product containing 2 medications: buprenorphine and naloxone.

Bunavail belongs 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. Avoid eating or drinking until the film has dissolved entirely.

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

Bunavail can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Bunavail affects you.

Bunavail is 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

Apply Bunavail buccal film as a single daily dose.

The recommended daily dose for maintenance is 8.4 mg/1.4 mg.

Serious side effects have been reported with Bunavail including the following:

• Respiratory problems. You have a higher risk of death and coma from respiratory problems if you take Bunavail 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
  • Goose bumps
  • Diarrhea
  • Vomiting
  • Muscle aches

Bunavail can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Bunavail affects you.

Do not take Bunavail 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 Bunavail. See the “Bunavail Precautions” section.

Common side effects of Bunavail include the following:

• Headache
• Drug withdrawal syndrome
• Nausea
• Decrease in sleep (insomnia)
• Vomiting
• Pain
• Increased sweating
• Constipation

This is not a complete list of Bunavail 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, Solfoton)
• phenytoin (Dilantin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• troglitazone (Rezulin)
• troleandomycin (TAO)
• verapamil (Calan, Covera, Isoptin, Verelan)
• zafirlukast (Accolate)

This is not a complete list of Bunavail 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.

Bunavail falls into category C. There are no well-controlled studies that have been done in pregnant women. Bunavail 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 Bunavail, a choice should be made whether to stop nursing or to stop use of this medication. Caution should be exercised when Bunavail is administered to a nursing woman. The importance of the drug to the mother should be considered.