Generic Name: buprenorphine (oral/buccal) (BUE pre NOR feen (OR al / BUK al))
Brand Name: Belbuca
What is buprenorphine buccal?
Buprenorphine is an opioid medication. Buprenorphine oral/buccal (placed between the gum and cheek) is for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines.
Buprenorphine is not for use on an as-needed basis for occasional pain.
Buprenorphine may also be used for purposes not listed in this medication guide.
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Before taking this medicine
You should not use buprenorphine if you are allergic to it, or if you have:
severe asthma or trouble breathing; or
a blockage in your stomach or intestines.
Tell your doctor if you have ever had:
breathing problems, sleep apnea;
liver disease (especially hepatitis B or C);
enlarged prostate, urination problems;
problems with your gallbladder, pancreas, or thyroid;
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 opioid medicine 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 opioids may need medical treatment for several weeks.
You should not breastfeed while you are using buprenorphine.
Buprenorphine is not approved for use by anyone younger than 18 years old.
How should I take buprenorphine buccal?
Follow the directions on your prescription label and read all medication guides. Never use buprenorphine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of buprenorphine.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
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 film has completely dissolved in your mouth.
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 buprenorphine.
Do not stop using buprenorphine 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 buprenorphine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use 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. 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 taking buprenorphine buccal?
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.
Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Buprenorphine buccal side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. 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;
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 side effects may include:
constipation, nausea, vomiting;
headache, dizziness, drowsiness;
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 buprenorphine buccal?
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");
other narcotic medications--opioid pain medicine or prescription cough medicine;
drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.03.
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