Buprenorphine buccal film
What is this medicine?
BUPRENORPHINE (byoo pre NOR feen) is a pain reliever. It is used to treat moderate to severe pain.
How should I use this medicine?
Take this medicine by mouth. Follow the directions on the prescription label. Wet the inside of your cheek with tongue or rinse mouth with water before using this medicine. Open package with dry hands just before you are ready to use. Do not cut or tear the film. Use the tip of a dry finger to put film in the mouth with the yellow side of the film facing the cheek. Hold the film in place for 5 seconds. After you place the medicine on your cheek leave the film in place until it dissolves away in about 30 minutes. Do not move or touch the film with fingers or tongue. Do not eat or drink until the film has dissolved. Do not chew or swallow the film. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellow of the eyes or skin
signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
trouble passing urine or change in the amount of urine
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
What may interact with this medicine?
Do not take this medication with any of the following medicines:
certain medicines for fungal infections like ketoconazole and itraconazole
This medicine may interact with the following medications:
antihistamines for allergy, cough and cold
antiviral medicines for HIV or AIDS
certain antibiotics like clarithromycin, erythromycin, linezolid, rifampin
certain medicines for anxiety or sleep
certain medicines for bladder problems like oxybutynin, tolterodine
certain medicines for depression like amitriptyline, fluoxetine, sertraline
certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
certain medicines for nausea or vomiting like dolasetron, ondansetron, palonosetron
certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
certain medicines for seizures like phenobarbital, primidone
certain medicines for stomach problems like cimetidine, dicyclomine, hyoscyamine
certain medicines for travel sickness like scopolamine
general anesthetics like halothane, isoflurane, methoxyflurane, propofol
local anesthetics like lidocaine, pramoxine, tetracaine
MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
medicines that relax muscles for surgery
other medicines that prolong the QT interval (cause an abnormal heart rhythm)
other narcotic medicines for pain or cough
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Where should I keep my medicine?
Keep out of the reach of children.
This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law. Follow the directions in the MedGuide.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).
This medicine may cause accidental overdose and death if it is taken by other adults, children, or pets. Return medicine that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medicine, remove any unused films from the foil packs and flush any down the toilet to reduce the chance of harm. Throw away the empty foil packaging in the trash. Do not use the medicine after the expiration date.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
blockage in your bowel
drink more than 3 alcohol-containing drinks per day
drug abuse or addiction
lung or breathing disease, like asthma
trouble passing urine or change in the amount of urine
an unusual or allergic reaction to buprenorphine, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
What should I watch for while using this medicine?
Tell your health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this drug. Tolerance means that you will need a higher dose of the drug for pain relief. Tolerance is normal and is expected if you take this drug for a long time.
Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the drug. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If you have pain, you have a medical reason to take pain drug. Your health care provider will tell you how much drug to take. If your health care provider wants you to stop the drug, the dose will be slowly lowered over time to avoid any side effects.
If you take other drugs that also cause drowsiness like other narcotic pain drugs, benzodiazepines, or other drugs for sleep, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.
Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.
This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.
July 31, 2020