Buprenorphine sublingual and buccal are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
Side Effects Of Buprenorphine Sublingual and Buccal (Opioid Dependence)
Buprenorphine sublingual and buccal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- difficulty falling asleep or staying asleep
- mouth numbness or redness
- tongue pain
- blurred vision
- back pain
Some side effects of buprenorphine sublingual and buccal can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections, call your doctor immediately:
- difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- 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
- slowed breathing
- upset stomach
- extreme tiredness
- blurred vision
- slurred speech
- unusual bleeding or bruising
- lack of energy
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- dark-colored urine
- light-colored stools
Buprenorphine sublingual and buccal may cause other side effects. Call your doctor if you have any unusual problems while taking or using this medication.
Warnings & Precautions
Before taking or using buprenorphine sublingual and buccal:
- tell your doctor and pharmacist if you are allergic to buprenorphine, naloxone, any other medications, or any of the other ingredients in buprenorphine or buprenorphine and naloxone sublingual tablets or film. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking with buprenorphine sublingual and buccal. Be sure to mention any of the following: antihistamines (found in cold and allergy medications); antipsychotics such as aripiprazole (Abilify), asenapine (Saphris), cariprazine (Vraylar), chlorpromazine, clozapine (Versacloz), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), loxapine, lurasidone (Latuda), molindone, olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimavanserin (Nuplazid), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, thiothixene, trifluoperazine, and ziprasidone (Geodon); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clobazam (Onfi), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, quazepam (Doral), temazepam (Restoril), and triazolam (Halcion); diuretics (‘water pills’); erythromycin (E.E.S., Eryc, Erythrocin, others); certain HIV medications such as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), and ritonavir (Norvir, in Kaletra, in Technivie); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson’s disease, ulcers, or urinary problems; ketoconazole; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); muscle relaxants; opiate (narcotic) medications for pain control and cough; rifampin (Rifadin, Rimactane, in Rifater, in Rifamate); medications for seizures such as carbamazepine (Epitol, Tegretol, Teril, others), phenobarbital, and phenytoin (Dilantin, Phenytek); 5HT3 serotonin blockers such as alosetron (Lotronex), granisetron (Sancuso, Sustol), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in 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); sleeping pills; tramadol (Conzip); trazodone; or tricyclic antidepressants (‘mood elevators’) such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). 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 within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with buprenorphine or buprenorphine and naloxone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects while using buprenorphine sublingual and buccal.
- tell your doctor what herbal products you are taking, especially St. John’s wort and tryptophan.
- tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had adrenal problems such as Addison’s disease (a condition in which the adrenal gland produces less hormone than normal); benign prostatic hypertrophy (BPH, enlargement of the prostate gland); difficulty urinating; a head injury; hallucinations (seeing things or hearing voices that do not exist); a curve in the spine that makes it hard to breathe; gallbladder disease; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); or thyroid, kidney, liver, or lung disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking or using buprenorphine sublingual and buccal, call your doctor. If you take or use buprenorphine or buprenorphine and naloxone tablets or film 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, seizures, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
- tell your doctor if you are breastfeeding. Tell your baby’s doctor right away if your baby is sleepier than usual or has trouble breathing while you are taking this medication.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking or using buprenorphine sublingual and buccal.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine sublingual and buccal.
- you should know that buprenorphine sublingual and buccal may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should not drink alcohol or take prescription or nonprescription medications that contain alcohol while taking or using this medication.
- you should know that buprenorphine sublingual and buccal may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking or using buprenorphine sublingual and buccal. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
Buprenorphine Sublingual and Buccal (Opioid Dependence) Dosage
Buprenorphine comes as a sublingual tablet. The combination of buprenorphine and naloxone comes as a sublingual tablet (Zubsolv) and as a sublingual film (Suboxone) to take under the tongue and as a buccal film (Bunavail) to apply between the gum and cheek. After your doctor determines an appropriate dose, these products are usually taken once a day. To help you remember to take or apply buprenorphine sublingual and buccal, take or apply it 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. Take or apply buprenorphine sublingual and buccal exactly as directed. Do not take or apply more or less of it or take or apply it more often than prescribed by your doctor.
Your doctor may decide to start your treatment with buprenorphine, which you will take in the doctor’s office. You will start on a low dose of buprenorphine and your doctor will increase your dose for 1 or 2 days before switching you to buprenorphine and naloxone. Depending on the type of opioid that you were taking, a different option that your doctor may choose is to start you on treatment with buprenorphine and naloxone right away. Your doctor may increase or decrease your buprenorphine sublingual and buccal dose depending on your response.
If you are taking the sublingual tablets, place the tablets under your tongue until they completely melt. If you are taking more than two tablets, either place them all under your tongue at the same time or place them under your tongue up to two at a time. Do not chew the tablets or swallow them whole. Do not eat, drink, or talk until the tablet dissolves completely.
If you are using the buccal film, use your tongue to wet the inside of your cheek or rinse your mouth with water before you apply the film. Apply the film with a dry finger against the inside of the cheek. Then remove your finger and the film will stick to the inside of your cheek. If you are to use two films, place another film on the inside of your other cheek at the same time. Do not apply films on top of each other and do not apply more than two films to the inside of the mouth at one time. Leave the film(s) in the mouth until they dissolve. Do not cut, tear, chew, swallow, touch or move the film while it dissolves. Do not eat or drink anything until the film dissolves completely.
If you are using the sublingual film, rinse your mouth with water before you place the film. Place the film with a dry finger under your tongue to the right or left of the center and hold the film in place for 5 seconds. If you are using two films, place the other one on the opposite side under the tongue. Do not put the films on top of or near each other. Do not use more than two films at one time. Do not cut, tear, chew, swallow, touch or move the film while it dissolves. Do not eat or drink anything until the film dissolves completely.
If you need to switch from one buprenorphine sublingual and buccal product to another, your doctor may need to adjust your dose. Each time you receive your medication, check to be sure that you have received the buprenorphine product that was prescribed for you. Ask your pharmacist if you have are not sure that you received the right medication.
Do not stop taking or using buprenorphine sublingual and buccal without talking to your doctor. Stopping buprenorphine sublingual and buccal too quickly can cause withdrawal symptoms. Your doctor will tell you when and how to stop taking or using buprenorphine sublingual and buccal. If you suddenly stop taking or using buprenorphine sublingual and buccal, you may experience withdrawal symptoms such as hot or cold flashes, restlessness, teary eyes, runny nose, sweating, chills, muscle pain, vomiting, or diarrhea.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to buprenorphine and naloxone.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine sublingual and buccal.
In case of an emergency, you or a family member should tell the treating doctor or emergency room staff that you are taking or using buprenorphine sublingual and buccal.
Do not inject buprenorphine sublingual and buccal sublingual film or tablets. Severe reactions may happen, including withdrawal symptoms.
Do not let anyone else take or use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring 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.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.