Description
Buprenorphine implant is used for the maintenance treatment of opioid (narcotic) dependence in patients who have received other medicines containing buprenorphine (eg, Suboxone®, Subutex®).
When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.
This medicine is to be given only by or under the direct supervision of a trained healthcare professional.
This product is available in the following dosage forms:
- Implant
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine implant in children younger than 16 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine implant in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine implant.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Naltrexone
- Pimozide
- Piperaquine
- Posaconazole
- Safinamide
- Samidorphan
- Saquinavir
- Sparfloxacin
- Terfenadine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Brain problems (eg, tumor, increased intracranial pressure), history of or
- Breathing problems, severe (eg, hypercapnia, hypoxia) or
- Chronic obstructive pulmonary disease (COPD) or
- CNS depression or
- Connective tissue disease (eg, scleroderma), history of or
- Cor pulmonale (serious heart condition) or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Gallbladder disease or
- Heart disease (eg, angina, congestive heart failure) or
- Head injuries, history of or
- Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
- Hepatitis B or C, history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood), severe or
- Hypothyroidism (an underactive thyroid) or
- Keloid formation, history of or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Mental illness or
- MRSA infection, history of or
- Problems with passing urine—Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure)—Use with caution. May make this condition worse.
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Probuphine® is an implant that is surgically placed and removed under the skin of the upper arm by a trained healthcare provider. The implants are placed in the upper arm for 6 months of treatment and are removed by the end of the sixth month.
Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be covered with 2 bandages. The top adhesive bandage will be placed over the arm and should be left on for 24 hours. Keep the smaller, bottom bandage clean and dry and in place for 3 to 5 days.
You should apply an ice pack to your arm for 40 minutes every 2 hours for the first 24 hours after placing the implants or as needed.
Your doctor will give you a patient identification card to carry with you.
Do not try to remove the implants by yourself.
If the implant sticks out or comes out: Wash your hands if you touch the implant. Cover the area where the implants were inserted with a clean bandage. Place the implant in a plastic bag, store it in a safe place out of the reach of children, and call your doctor right away.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, linezolid [Zyvox®], phenelzine [Nardil®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
If you have been using this medicine regularly for several weeks or longer, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects (eg, abdominal or stomach cramps, fever, runny nose, anxiety, or restlessness).
Using too much buprenorphine may cause an overdose. Symptoms of overdose include: blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sweating, or unusual tiredness or weakness.
Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problem.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Chest pain
- dizziness
- headache, severe and throbbing
- lack or loss of strength
- sleepiness or unusual drowsiness
Incidence not known
- Agitation
- bleeding, itching, pain, redness, scarring, or swelling at the incision
- chest tightness
- confusion
- cough
- dark urine
- darkening of the skin
- diarrhea
- difficult or trouble breathing
- difficulty with swallowing
- fainting
- fast heartbeat
- fever
- general tiredness and weakness
- hives, itching, or skin rash
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- mental depression
- noisy breathing
- overactive reflexes
- pale or blue lips, fingernails, or skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm
- sleepiness
- sweating
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- depression
- difficulty having a bowel movement (stool)
- headache
- mouth pain
- nausea
- sneezing
- stuffy or runny nose
- toothache
- vomiting
Less common
- Bloated
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- excess air or gas in stomach or intestines
- full feeling
- pain in the arms or legs
- passing gas
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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