What is the most important information I should know about buprenorphine buccal?
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
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.
This medicine 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.
What should I discuss with my healthcare provider before taking buprenorphine buccal?
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:
- tooth problems, including a history of cavities;
- breathing problems, sleep apnea;
- kidney or liver disease (especially hepatitis B or C);
- 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 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 this medicine.
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.
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. Rinse your mouth with water after the medicine dissolves. Wait one hour after the film dissolves to brush your teeth to prevent damage to the teeth and gums. 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 should receive regular dental checkups while taking buprenorphine buccal.
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 this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
What are the possible side effects of buprenorphine buccal?
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:
- any problems with your teeth or gums, 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 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 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"), medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other opioid medications --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 affect buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Where can I get more information?
Your doctor or pharmacist can provide more information about buprenorphine.
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.
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