Belbuca : Uses, Side Effects, Interactions & More
Belbuca can create a habit, especially with prolonged use. Apply Belbuca exactly as directed. Do not apply more Belbuca oral films, use oral films more often, or use oral films in a different way than prescribed by your doctor. While using Belbuca, talk to your healthcare provider about your pain management goals, the duration of treatment, and other ways to manage your pain. Tell your doctor if you or someone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used illegal drugs, or has overused prescription drugs, or if you have or have ever had depression or other Mental illness. There is an increased risk that you overuse Belbuca if you have or have ever had any of these conditions. Talk to your healthcare provider right away and ask for guidance if you think you have an opioid addiction, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) national helpline at 1-800-662-HELP.
Belbuca can cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours and each time your dose is increased. Your doctor will monitor you carefully during your treatment. Your doctor will adjust your dose carefully to control your pain and decrease the risk of serious breathing problems. Tell your doctor if you have trouble breathing and if you have or have ever had asthma. Your doctor may tell you not to use Belbuca. Also tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), other lung diseases, a head injury, brain tumor, or any condition that increases the amount of pressure on the brain. The risk of developing respiratory problems may also be higher if you are an older adult or are weakened or malnourished due to illness. If you have any of the following symptoms, call your doctor immediately: shortness of breath, shortness of breath, extreme drowsiness, fainting, or loss of consciousness.
Taking certain medications with Belbuca can increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan) , oxazepam, temazepam (Restoril) and triazolam (Halcion); medications for mental illness and nausea; other pain medications; muscle relaxants; sedative sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medications and will monitor you carefully. If you use Belbuca with any of these medicines and develop any of the following symptoms, call your doctor immediately or seek emergency medical attention: unusual dizziness, light-headedness, extreme drowsiness, slow or difficult breathing, or lack of response. Make sure your caregiver or family members know what symptoms can be serious so that they can call the doctor or emergency medical attention if they are unable to seek treatment on their own.
Drinking alcohol, taking prescription or over-the-counter medications containing alcohol, or using illegal drugs while taking Belbuca increases your risk of experiencing these serious and life-threatening side effects. Do not drink alcohol or use illegal drugs during your treatment.
Belbuca can cause serious harm or death if accidentally used by a child or adult who has not been prescribed the medication. Do not let anyone else use your medicine. Store Belbuca in a safe place so that no one else can use it accidentally or on purpose. Keep track of how many vestibular films are left to see if any are missing.
Tell your doctor if you are pregnant or plan to become pregnant. If you use Belbuca regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, crying, uncontrollable shaking of a part of the body, vomiting, diarrhea, or lack of weight gain.
Your doctor or pharmacist will provide you with the manufacturer’s patient information sheet (Medication Guide) when you start treatment with Belbuca and each time you get a refill. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of using Belbuca.
Why is this medication prescribed?
Belbuca (Buprenorphine) is used to relieve severe pain in people who are expected to need pain medications throughout the day for a long time and who cannot be treated with other medications. Belbuca should not be used to treat pain that can be controlled with medications taken as needed. Belbuca in a class of medications called partial opiate agonists. It works by changing the way the brain and nervous system respond to pain.
How should this medicine be used?
Belbuca (Buprenorphine) comes as a Belbuca film to apply inside the cheek. It is usually applied twice a day. Apply Belbuca at around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Use Belbuca exactly as directed.
Your doctor will probably start with a low dose of Belbuca, either once a day or every 12 hours, and will gradually increase your dose, not more than once every 4 days. Your doctor may decrease your dose if you experience side effects. Tell your doctor if you feel that your pain is not controlled or if you experience side effects during your treatment with Belbuca. Do not change the dose of your medicine without talking to your doctor.
Do not stop using Belbuca without talking to your doctor. Your doctor will probably reduce your dose gradually. If you suddenly stop using Belbuca, you may have withdrawal symptoms. Call your doctor if you experience any of these withdrawal symptoms: restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle and back pain, large pupils (black circles in the center of the eyes), irritability, anxiety, difficulty. falling asleep or falling asleep, diarrhea, nausea, vomiting, decreased appetite, stomach cramps, joint pain, weakness, fast heartbeat, or rapid breathing.
Belbuca is sealed in an aluminum package. Do not open the package until you are ready to use. Do not apply Belbuca if the seal of the package is broken or if the oral film is cut, damaged or changed in any way.
To apply the Belbuca film, follow these steps:
- Fold along the dotted line at the top of the foil package. Keep it bent and tear or cut with scissors at the notch in the direction of the scissors on the dotted line. Tear to the bottom. Take care to avoid cutting and damaging the vestibular film when using scissors.
- Use your tongue to moisten the inside of the cheek, or rinse your mouth with water to moisten the area of the mouth where you will apply the oral film. Avoid placing the oral film in areas with open sores.
- Remove the oral film from the package and hold it with clean, dry fingers with the yellow side facing up.
- Immediately place the yellow side of the Belbuca film against the inside of the moistened cheek. Hold the Belbuca film in place for 5 seconds, and then remove your finger.
- The oral film should stick against your cheek. Leave the Belbuca film in place until it has completely dissolved, usually within 30 minutes after application. Avoid touching or moving the mouth film with your tongue or fingers after applying it. Do not eat or drink anything until the oral film has completely dissolved. Do not chew or swallow the oral film.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using Belbuca,
- Tell your doctor and pharmacist if you are allergic to Belbuca, any other medications, or any of the ingredients in Belbuca oral films. Consult your pharmacist or consult the Medication Guide for a list of ingredients.
- Tell your doctor and pharmacist what other prescription and over-the-counter medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Nexterone, Pacerona); anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine); butorphanol; carbamazepine (Carbatrol, Tegretol, Teril, others); clarithromycin (Biaxin, in Prevpac); cyclobenzaprine (Amrix); dextromethorphan (found in many cough medicines; in Nuedexta); disopyramide (Norpace); diuretics (‘water pills’); dofetilide (Tikosyn); enzalutamide (Xtandi); medications for human immunodeficiency virus (HIV) such as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine ( Viramune), ritonavir (Norvir, in Kaletra) and saquinavir (Invirase); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); lithium (Lithobid); migraine medications such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; nefazodone; pentazocine (Talwin); phenobarbital; phenytoin (Dilantin, Phenytek); pioglitazone (Actos); procainamide; quinidine (in Nuedexta); rifabutin (mycobutin); rifampicin (rifadine, rimactane); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz) or palonosetron (Aloxi); selective serotonin reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva) and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors, such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); tramadol (Conzip, Ultram, in Ultracet); trazodone; sotalol (Betapace, Sotylize, others); or tricyclic antidepressants (‘mood elevators’) such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramin. Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them in the last two weeks: isocarboxazide (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil ), selegiline (Eldepryl, Emsam, Zelapar) or tranilcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications can also interact with Belbuca, so be sure to tell your doctor about all the medications you are taking, even those that are not listed here.
- Tell your doctor what herbal products you are taking, especially St. John’s wort and tryptophan.
- Tell your doctor if you have any of the conditions listed in the IMPORTANT WARNING section or paralytic ileus (a condition in which food does not move through the intestines) or a blockage in the stomach or intestines. Your doctor may tell you not to use Belbuca.
- Tell your doctor if you or a member of your immediate family has or has ever had prolonged QT syndrome (a condition that increases the risk of developing an irregular heartbeat that can cause loss of consciousness or sudden death); if you have low levels of potassium or magnesium in your blood; and if you have or have ever had a slow or irregular heartbeat; heart failure; low blood pressure; any condition that causes difficulty urinating; seizures mouth ulcers; or gallbladder, pancreas, kidney, thyroid, or liver disease.
- Tell your doctor if you are breastfeeding.
- You should know that this medicine can decrease fertility in men and women. Talk to your doctor about the risks of using Belbuca.
- If you are going to have surgery, including dental surgery, tell the doctor or dentist that you are using Belbuca.
- You should know that Belbuca can cause drowsiness. Do not drive a car or operate machinery until you know how this medicine affects you.
- You should know that Belbuca can cause dizziness, lightheadedness and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- You should know that Belbuca can cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while using Belbuca.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.
What side effects can this medication cause?
Belbuca may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dry mouth
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- changes in heartbeat
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- chest pain
- swelling of your face, tongue or throat
Belbuca can cause other side effects. Call your doctor if you have any unusual problems while using this medicine.
If you experience a serious side effect, you or your doctor can submit an online report to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medicine in its container, tightly closed and out of the reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Throw away any medicine as soon as it is out of date or no longer needed. Immediately dispose of any out-of-date or unnecessary medicine through a drug take-back program. If you don’t have a nearby return program or one that you can quickly access, remove the unused films from their foil packages and flush them down the toilet. Throw away the aluminum packaging. Do not flush Belbuca down the toilet in foil packages or cartons.
It is important to keep all medications out of the sight and reach of children, as many containers (such as those for taking pills weekly and those used for eye drops, creams, patches, and inhalers) are not resistant to children and children. young children can easily open them. To protect young children from poisoning, always close the safety caps and immediately put the medicine in a safe place, one that is up and away and out of your sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help.
If the victim collapsed, had a seizure, is having trouble breathing, or cannot wake up, call 911 immediately.While using Belbuca, you may be told to always have a rescue medicine called naloxone available (for example, at home, in the office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opioids to relieve dangerous symptoms caused by high levels of opiates in the blood. You probably cannot be treated if you experience an opioid overdose. You should make sure that your family members, caregivers, or people who spend time with you know if you are experiencing an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medicine. Ask your pharmacist for instructions or visit the manufacturer’s website for instructions. If someone sees that you are experiencing symptoms of an overdose, you should give them your first dose of naloxone, call 911 immediately, and stay with you and keep a close eye on it until emergency medical help arrives. Your symptoms may come back within a few minutes after receiving naloxone. If his symptoms return, the person should give him another dose of naloxone. Additional doses may be administered every 2 to 3 minutes, if symptoms return before medical help arrives.
Symptoms of overdose may include the following:
- slowed or difficulty breathing
- extreme sleepiness or drowsiness
- coma (loss of consciousness for a period of time)
- slow heartbeat
- cold, clammy skin
- muscle weakness
- narrowing or widening of the pupils (black circles in the center of the eye)
- unusual snoring
What other information should I know?
Keep all appointments with your doctor and laboratory. Your doctor may order certain laboratory tests to check your body’s response to Belbuca.
Before having a laboratory test (especially those involving methylene blue), tell your doctor and laboratory personnel that you are using Belbuca.
Do not allow anyone to use your medicine. Belbuca is a controlled substance. Recipes can be replenished only a limited number of times; ask your pharmacist if you have any questions.
It is important to keep a written list of all prescription and over-the-counter (non-prescription) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should carry this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.