Generic name: buprenorphine (oral/buccal) (BUE pre NOR feen (OR al / BUK al))
Brand name: Belbuca
Drug class: Narcotic analgesics
Belbuca buccal films contain buprenorphine, an opioid medication. An opioid is sometimes called a narcotic.
Belbuca buccal films are for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines.
Belbuca is not for use on an as-needed basis for occasional pain.
The Belbuca buccal film is placed between the gum and cheek where it adheres to the moist buccal mucosa to deliver the medicine as the film dissolves.
Warnings
Belbuca can slow or stop your breathing, and may be habit-forming. MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Using Belbuca during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use Belbuca with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Before using this medicine
You should not use Belbuca if you are allergic to buprenorphine, or if you have:
- severe asthma or trouble breathing; or
- a blockage in your digestive tract, including a bowel obstruction called paralytic ileus.
To make sure Belbuca is safe for you, tell your doctor if you have ever had:
- breathing problems, sleep apnea;
- liver disease (especially hepatitis B or C);
- kidney disease;
- enlarged prostate, urination problems;
- problems with your gallbladder, pancreas, or thyroid;
- a head injury, brain tumor, or seizures;
- drug addiction, methadone use, alcoholism, mental illness;
- mouth sores caused by cancer;
- an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
- long QT syndrome, or if you take heart rhythm medication.
If you use Belbuca 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 or plan to become pregnant.
Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breastfeed while you are using Belbuca.
Belbuca is not approved for use by anyone younger than 18 years old.
How should I use Belbuca?
Use Belbuca exactly as prescribed by your doctor. Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use Belbuca in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Buprenorphine may be habit-forming, even at regular doses. 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 Belbuca is against the law.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Drink a glass of water to moisten your mouth. Use dry hands when handling the buccal film. Place the film against the inside of your cheek and hold it in place for 5 seconds. Once in place, the film will dissolve completely in about 30 minutes. Do not chew the film or swallow it whole.
Do not eat or drink anything until the Belbuca film has completely dissolved in your mouth.
While using Belbuca, you may need frequent blood tests to check your liver function.
If you need surgery, tell the surgeon ahead of time that you are using Belbuca.
Do not stop using Belbuca suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using buprenorphine.
Store at room temperature away from moisture and heat. Keep the medicine in a place where a child cannot get to it. Keep track of your medicine. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. 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.
What happens if I miss a dose?
Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.
Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, severe muscle weakness, pinpoint pupils, weak pulse, very slow breathing, or coma.
What should I avoid while using Belbuca?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid applying the buccal film to an area where you have a mouth sore.
Buprenorphine may impair your thinking or reactions. Avoid driving or operating machinery until you know how Belbuca will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Belbuca side effects
Get emergency medical help if you have signs of an allergic reaction to Belbuca: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, buprenorphine 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 if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- slow heartbeat or weak pulse;
- a light-headed feeling, like you might pass out;
- chest pain, fast heart rate, trouble breathing;
- severe constipation;
- opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
- low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
- liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
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.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
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 Belbuca side effects may include:
- constipation, nausea, vomiting;
- headache, dizziness, drowsiness;
- increased sweating;
- sleep problems (insomnia); or
- pain anywhere in your body.
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.
What other drugs will affect Belbuca?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other narcotic medications - opioid pain medicine or prescription cough medicine;
- a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
- drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.