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Buprenorphine Buccal (chronic pain)

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WARNING

It’s possible for buprenorphine (Belbuca) to develop a habit with repeated use. Buprenorphine should only be used as prescribed. Applying additional buccal films of buprenorphine, using them more frequently, or using them otherwise than as directed by your doctor are all prohibited. Discuss your pain management options, treatment duration, and goals with your healthcare professional while using buprenorphine. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you currently have or have ever had any of these conditions, there is a higher chance that you may abuse buprenorphine. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Breathing issues can be severe or even fatal when taking buprenorphine (Belbuca), particularly in the first 24 to 72 hours and if your dose is raised. Throughout your therapy, your doctor will keep a close eye on you. To manage your pain and lower your risk of developing severe breathing issues, your doctor will carefully modify your dosage. If you have trouble breathing or have previously had asthma, let your doctor know. Your physician might advise against using buprenorphine (Belbuca.) Additionally, let your doctor know if you currently have COPD or have ever had it (COPD; a group of diseases that affect the lungs and airways), any illness that raises the pressure inside your brain, including additional lung ailments, head trauma, brain tumours, or other conditions. You have a greater danger of developing breathing issues if you’re an older adult, sickly-weakened, or undernourished. Call your doctor right away if you experience any of the following signs or symptoms: Shortness of breath, excessive sleepiness, fainting, or loss of consciousness are all symptoms of breathing trouble.

Buprenorphine (Belbuca) with certain drugs together may increase the risk of serious or life-threatening respiratory issues, drowsiness, or coma. If you already take or intend to take any of the following medications, inform your doctor and pharmacist right away: Benzodiazepines such as chlordiazepoxide and alprazolam (Xanax) (Librium), drugs for mental illness and nausea; other painkillers; muscle relaxants; sedatives; sleeping pills; or tranquillizers. These include clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion). Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms while taking buprenorphine together with any of these drugs: unusual dizziness, lightheadedness, excessive drowsiness, sluggish or laboured breathing, or inability to respond. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

You run a higher chance of developing these severe, potentially fatal adverse effects while receiving treatment with buprenorphine if you consume alcohol, take prescription or over-the-counter meds that include alcohol, or use illicit substances. During your treatment, refrain from drinking alcohol and other illegal substances.

If mistakenly taken by a kid or an adult who has not been prescribed the drug, buprenorphine (Belbuca) can result in severe injury or even death. Don’t let anyone else take your medication. Belbuca (buprenorphine) should be kept in a secure location to prevent accidental or intentional usage by others. Keep note of how many buccal films are still available so you can identify any that are missing.

If you are pregnant or want to become pregnant, let your doctor know. Regular buprenorphine usage during pregnancy increases the risk that your unborn child could have potentially fatal withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start buprenorphine (Belbuca) medication and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Consult your physician regarding the dangers of using buprenorphine (Belbuca).

Why is this medication prescribed?

Buprenorphine (Belbuca) is used to treat severe pain in patients who cannot be treated with other medications and are anticipated to require pain medication 24 hours a day for a prolonged period of time. Belbuca, which contains buprenorphine, should not be used to relieve pain that can be managed with as-needed medicine. Opiate partial agonists are a group of medicines that includes buprenorphine (Belbuca). It functions by altering how the nerve system and brain react to pain.

How should this medicine be used?

Belbuca, which contains buprenorphine, is available as a buccal film to place inside the cheek. Usually, it is applied twice daily. Buprenorphine (Belbuca) should be administered daily at roughly the same times. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the Belbuca (buprenorphine) directions precisely.

Your doctor will likely put you on a modest dose of buprenorphine (Belbuca), once per day or every twelve hours, and gradually raise your dose, not more frequently than once every four days. If you encounter side effects, your doctor might reduce your dose. If you believe that your pain is not being controlled or if you encounter side effects while taking buprenorphine, let your doctor know (Belbuca). Without first consulting your doctor, never alter the dosage of your prescription.

Without consulting your doctor, never discontinue taking buprenorphine (brand name Belbuca). Most likely, your dosage will be gradually reduced by your doctor. You can experience withdrawal symptoms if you abruptly stop using buprenorphine (Belbuca). Call your doctor if you experience any of these withdrawal symptoms: agitation, teary eyes, runny nose, yawning, sweating, chills, muscle and back aches, large pupils (black circles in the centre of the eyes), irritability, anxiety, trouble falling or staying asleep, diarrhoea, nausea, vomiting, decreased appetite, stomach cramps, pain in the joints, weakness, rapid heartbeat, or rapid breathing.

A foil container containing buprenorphine (Belbuca) is sealed. Keep the package closed until you’re ready to use it. Applying buprenorphine (Belbuca) is not advised if the buccal film is cut, damaged, or altered in any way, or if the package seal is broken.

Apply the buccal film by doing the following steps:

  1. The top of the foil packet should be folded along the dotted line. Keep folded and cut with scissors along the dotted line at the notch in the direction of the scissors. To the very bottom, tear. When using scissors, use caution to prevent cutting and harming the buccal film.
  2. To moisten the area in your mouth where the buccal film will be applied, use your tongue to moisten the inside of your cheek or to rinse your mouth out with water. Buccal film placement should be avoided near open wounds.
  3. With the yellow side facing up, take out the buccal film from the packaging and hold it in your clean, dry hands.
  4. Put the buccal film’s yellow side on the inside of your moistened cheek right away. For 5 seconds, press and hold the buccal film in place, then remove your finger.
  5. You want the buccal film to adhere to your cheek. The buccal film should dissolve fully within 30 minutes of application, so keep it in place until then. After application, refrain from using your tongue or fingers to touch or move the buccal film. Eat or drink nothing until the buccal film has entirely disappeared. Avoid swallowing or chewing the buccal film.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using buprenorphine (Belbuca),

  • If you have an allergy to buprenorphine, any other drugs, or any of the ingredients in buprenorphine buccal films, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: Butorphanol; carbamazepine (Carbatrol, Tegretol, Teril, others); amiodarone (Cordarone, Nexterone, Pacerone); anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine);Diuretics (‘water pills’), dofetilide (Tikosyn), enzalutamide (Xtandi), clarithromycin (Biaxin, in Prevpac), cyclobenzaprine (Amrix), dextromethorphan (present in many cough medicines; in Nuedexta), disopyramide (Norpace), and human immunodeficiency virus (HIV) drugs such atazanavir (Reyataz, in Evotaz), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), lithium (Lithobid), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), Almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and others are migraine drugs, phenobarbital, phenytoin (Dilantin, Phenytek), zolmitriptan (Zomig), mirtazapine (Remeron), nalbuphine, nefazodone, pentazocine (Talwin), pioglitazone (Actos), procainamide, and quinidine (in Nuedexta); 5HT3 serotonin blockers like alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors, tramadol (Conzip, Ultram, in Ultracet), trazodone, and sotalol (Betapace, Sotylize, others); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); or tricyclic antidepressants (often known as “mood elevators”), including amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Additionally, let your doctor or pharmacist know if you’re receiving any of the following monoamine oxidase (MAO) inhibitors or if you’ve recently stopped taking them: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Buprenorphine may also interact with many other drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort and tryptophan.
  • If you have any of the ailments detailed in the IMPORTANT WARNING section, paralytic ileus (a condition in which food does not pass through the intestines), a blockage in the stomach, or any other medical issue, let your doctor know right once. Your physician might advise against using buprenorphine (Belbuca).
  • If you or a member of your family has prolonged QT syndrome (a condition that raises the chance of experiencing an abnormal heartbeat that could result in loss of consciousness or sudden death), let your doctor know; if you suffer from seizures, low blood pressure, heart failure, low potassium or magnesium levels, slow or irregular heartbeat, gallbladder, pancreatic, kidney, thyroid, or liver problems, mouth sores, or any condition that makes it difficult to urinate.
  • Describe to your doctor if you are nursing a baby.
  • You should be aware that this medicine may lower both male and female fertility. The hazards of using buprenorphine should be discussed with your doctor.
  • Inform the surgeon or dentist that you are taking buprenorphine if you are having surgery, including dental surgery (Belbuca).
  • You need to be aware that buprenorphine (Belbuca) can cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • You should be aware that if you stand up too rapidly from a laying position while taking buprenorphine (Belbuca), you could have dizziness, lightheadedness, and fainting. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • Buprenorphine (Belbuca) might produce constipation, therefore you should be aware of it. While taking buprenorphine, discuss with your doctor whether you should alter your diet or take additional drugs to prevent or cure constipation (Belbuca).

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

As soon as you realise you missed a dose, administer it. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. Applying a second dose to make up for a missed one is not advised.

What side effects can this medication cause?

There could be negative effects from buprenorphine (Belbuca). If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Dry mouth
  • Sleepiness
  • Headache

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Alterations in heartbeat
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Chest ache
  • Swelling in your throat, tongue, or face
  • Rash
  • Hives

Other adverse effects of buprenorphine (Belbuca) are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As soon as a drug is no longer needed or has expired, dispose of it. Utilize a drug take-back programme to properly dispose of any medication that is no longer needed or outdated. Remove any unwanted films from their foil packaging and flush them down the toilet if there isn’t a take-back programme available to you locally or that you can quickly reach. The foil package should be discarded in the garbage. Buprenorphine (Belbuca) in foil or carton packaging should not be flushed down the toilet.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

While using buprenorphine (Belbuca), you should speak with your doctor about keeping naloxone, a life-saving drug, close at hand (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or pharmacist. For the directions, speak to your pharmacist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Overdose signs could include the following:

  • Breathing slowly, shallowly, or having trouble breathing
  • Excessive tiredness or sleepiness
  • Not able to speak or awaken
  • Sluggish heartbeat
  • Clammy, frigid skin
  • Muscular tremor
  • Pupil dilation or dilation of the pupils (black circles in the centre of the eye)
  • Uncommon snoring

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor how your body is responding to buprenorphine, your doctor may request specific lab tests.

Inform your doctor and the lab staff that you are using buprenorphine prior to any laboratory test (particularly ones involving methylene blue).

Do not share your medication with anybody else. Belbuca (buprenorphine) is a restricted drug. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Belbuca®
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