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Buprenorphine sublingual tablets

What is this medicine?

BUPRENORPHINE (byoo pre NOR feen) is used to treat certain types of drug dependence.

How should I use this medicine?

The medicine is placed under the tongue and allowed to dissolve. Several minutes will be needed to allow the tablet to fully dissolve. If your dose requires you to take more than 2 tablets at once, either place all the tablets at once under the tongue, or if you cannot fit more than 2 tablets comfortably, place 2 tablets at a time under the tongue. Either way, you should hold the tablets under the tongue until they completely dissolve. Do not swallow or chew the tablet. Do not inject the medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by your healthcare provider each time this medicine is inserted into your arm. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years of age for selected conditions, precautions do apply.

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

  • breathing problems

  • confusion

  • 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):

  • constipation

  • dry mouth

  • nausea, vomiting

  • tiredness

What may interact with this medicine?

Do not take this medication with any of the following medicines:

  • cisapride

  • certain medicines for fungal infections like ketoconazole and itraconazole

  • dronedarone

  • pimozide

  • thioridazine

This medicine may interact with the following medications:

  • alcohol

  • antihistamines for allergy, cough and cold

  • antiviral medicines for HIV or AIDS

  • atropine

  • 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

  • diuretics

  • dofetilide

  • general anesthetics like halothane, isoflurane, methoxyflurane, propofol

  • ipratropium

  • local anesthetics like lidocaine, pramoxine, tetracaine

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

  • medicines that relax muscles for surgery

  • methylene blue

  • other medicines that prolong the QT interval (cause an abnormal heart rhythm)

  • other narcotic medicines for pain or cough

  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine

  • ritonavir

  • ziprasidone

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:

  • brain tumor

  • drink more than 3 alcohol-containing drinks per day

  • head injury

  • heart disease

  • kidney disease

  • liver disease

  • lung disease such as asthma or COPD

  • an unusual or allergic reaction to buprenorphine, naloxone, morphine, codeine, other medicines, lactose, mannitol, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

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.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider. Copyright© 2020 Elsevier