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Bunavail

Generic Name: buprenorphine and naloxone (buccal film) (BUE pre NOR feen and nal OX one
Brand Names: Bunavail

Medically reviewed on March 11, 2018

What is Bunavail?

Bunavail buccal films contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Bunavail buccal films are used to treat narcotic (opiate) addiction.

Bunavail is not to be used as a pain relieving medication.

Important Information

Bunavail can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking Bunavail during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Bunavail with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Bunavail if you are allergic to buprenorphine or naloxone (Narcan).

Tell your doctor if you have ever had:

Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use Bunavail while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.

Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Bunavail?

Use Bunavail exactly as directed by your doctor Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use Bunavail in larger amounts, or for longer than prescribed.

Bunavail may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Bunavail is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use dry hands when handling Bunavail. Place the Bunavail buccal film against the inside of your cheek. Allow the medicine to dissolve slowly. Do not chew or swallow it whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Bunavail suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Bunavail. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Store this medicine in the foil pouch at room temperature, away from moisture and heat. Discard an empty pouch in a place children and pets cannot get to.

Keep track of your medicine. This medicine is a drug of abuse and you should be aware if anyone is using it improperly.

Do not keep leftover Bunavail. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused films from the foil pack and flush the films down the toilet. Throw the empty foil pack into the trash.

Bunavail dosing information

Usual Adult Dose for Opiate Dependence: Buprenorphine monotherapy is generally used for induction. Bunavail may be used for induction in patients dependent on heroin or short-acting opioid products. Note - one Bunavail 4.2 mg/0.7 mg buccal film provides the equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.

INDUCTION dose: Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptoms
Day 2: a single dose up to 8.4 mg/1.4 mg buccally.

MAINTENANCE Treatment: Doses should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.
-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg
Maximum dose: 12.6 mg/ 2.1 mg buccally once a day.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using this medicine without a prescription.

Overdose symptoms may include extreme drowsiness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, very slow breathing, or coma.

What should I avoid while taking Bunavail?

Do not drink alcohol. Dangerous side effects or death could occur.

See also: Bunavail and alcohol (in more detail)

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Bunavail side effects

Get emergency medical help if you have signs of an allergic reaction to Bunavail: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, Bunavail can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

  • weak or shallow breathing, feeling like you might pass out;

  • confusion, loss of coordination, extreme weakness;

  • blurred vision, slurred speech;

  • liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

  • opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Bunavail side effects may include:

  • dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;

  • withdrawal symptoms;

  • tongue pain, redness or numbness inside your mouth;

  • nausea, vomiting, constipation;

  • headache, back pain;

  • fast or pounding heartbeats, increased sweating; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Bunavail?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

This list is not complete. Other drugs may affect Bunavail, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Bunavail only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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