Buprenorphine; Naloxone oral dissolving film
What is this medicine?
BUPRENORPHINE; NALOXONE (byoo pre NOR feen; nal OX one) is used to treat certain types of drug dependence.
How should I use this medicine?
For sublingual use (Suboxone): Drink water to moisten the mouth. Then, place the medicine under the tongue and let it dissolve. Follow the directions on the prescription label. Leave this medicine in the sealed foil pack until you are ready to use it. If your dose requires you to take more than 1 film, place the second film under the tongue on other side of the mouth. If your dose requires you to take more than 2 films, place the third film under your tongue on either side after the first 2 films have dissolved. Do not let the films touch in your mouth. After you put this medicine in your mouth, do not move it. Do not swallow, cut, or chew the film. Take your medicine at regular intervals. Do not take your medicine more often than directed.
For buccal use (Suboxone or Bunavail): Drink water to moisten the inside of the cheek. Then, place the medicine against the inside of the moistened cheek and let it dissolve. Follow the directions on the prescription label. Leave this medicine in the sealed foil pack until you are ready to use it. If your dose requires you to take more than 1 film, place the second film on the inside of the other cheek. If your dose requires you to take more than 2 films, place the third film on the inside of your right or left cheek after the first 2 films have dissolved. After you put this medicine in your mouth, do not move it. Do not swallow, cut, or chew the film. Take your medicine at regular intervals. Do not take your medicine more often than directed.
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, linezold, 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.
Store at room temperature between 15 and 30 degrees C (56 and 86 degrees F).
This medicine may cause harm 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, flush it down the toilet. 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:
drink more than 3 alcohol-containing drinks per day
lung or breathing disease, like asthma
an unusual or allergic reaction to buprenorphine, naloxone, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
What should I watch for while using this medicine?
Visit your health care provider regularly. Attend counseling or support groups that your health care provider recommends. Do not try to overcome the effects of the drug by taking large amounts of narcotics. This can cause severe problems including death. Also, you may be more sensitive to lower doses of narcotics after you stop taking this drug.
Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the 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.
Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the drugs and doses you take on the card.
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