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.

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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.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bunavail, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Bunavail, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to buprenorphine and naloxone or to any of its ingredients
• have or have had adrenal problems such as Addison's disease
• have or have had benign prostatic hypertrophy (BPH, enlargement of the prostate gland)
• have or have had difficulty urinating
• have or have had a head injury
• have or have had hallucinations (seeing things or hearing voices that do not exist)
• have a curve in the spine that makes it hard to breathe
• have or have had gallbladder disease
• have or have had stomach conditions
• have or have had thyroid disease
• have or have had kidney disease
• have or have had liver disease
• have trouble breathing or lung problems
• have a history of alcoholism
• drink large amounts of alcohol
• are pregnant or breastfeeding

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

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.

Take Bunavail exactly as prescribed.

Bunavail 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. The various forms of medication are not interchangeable.

• Do not take Bunavail more often than prescribed by your doctor.
• Take Bunavail 1 time a day.
• You may be prescribed a dose of 2 or more Bunavail buccal films to be taken at the same time.
• Use the entire Bunavail buccal film. Do not cut, tear, chew, or swallow the buccal film. Your doctor should show you how to use Bunavail the right way.
• Follow the same instructions every time you take a dose of Bunavail buccal film.
• Bunavail comes in a child-resistant foil package. Do not open the foil package until you are ready to use the Bunavail buccal film. After opening the foil package, use Bunavail buccal film right away.

Take the dose prescribed by your doctor as follows:

• To open the Bunavail buccal film foil package, fold along the dotted lines and tear down at slits or cut with scissors in the direction of the arrows
• Use your tongue to wet the inside of your cheek or rinse your mouth with water to moisten the area in your mouth before you place Bunavail.
• Hold the Bunavail buccal film with clean, dry fingers with the text (BN2, BN4, or BN6) facing up.
• Place the Bunavail buccal film inside your mouth with the text (BN2, BN4, or BN6) against the inside of your moistened cheek.
• With your finger, press the Bunavail buccal film against your cheek. Hold it there for 5 seconds.
• Take your finger away from the Bunavail buccal film. It will stick to the inside of your cheek.
• Leave the film in place until it dissolves.
• If your doctor tells you to use more than one Bunavail buccal film at the same time, place the next film on the inside of your other cheek following the instructions above. Do not place more than two buccal films to the inside of one cheek at a time.
• Avoid touching or moving the buccal film with your tongue or fingers.
• Avoid drinking or eating food until after the buccal film has dissolved.
• If you miss a dose of Bunavail, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
• Do not stop taking Bunavail suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using Bunavail the right way.

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.

If you take too much buprenorphine and naloxone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If buprenorphine and naloxone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Bunavail at at 20-25°C (68-77°F).
• Protect Bunavail from freezing and moisture. Do not use if the foil package has been damaged.
• Keep this and all medicines out of the reach of children.