Buprenorphine injection is used to relieve moderate to severe pain. Buprenorphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain.
Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose.
Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly.
However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped. completely. This medicine is available only with your doctor's prescription.
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 population
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of buprenorphine injection in children 2 to 12 years of age. However, safety and efficacy have not been established in children younger than 2 years of age.
Geriatric population
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine injection.
Pregnancy and Lactation:Category C
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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:
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.
- Acepromazine, Alfentanil, Alphaprodine,Alprazolam, Alvimopan, Amisulpride, Amobarbital, Anileridine, Aripiprazole, Asenapine, Atazanavir
- Baclofen, Benperidol, Bromazepam, Buspirone, Butabarbital, Butorphanol,
- Carbinoxamine, Carisoprodol, Carphenazine, Chloral Hydrate, Chlordiazepoxide
- Chlorpromazine, Chlorzoxazone, Clobazam, Clonazepam, Clorazepate, Clozapine, Codeine Cyclobenzaprine
- Dexmedetomidine, Dezocine, Diacetylmorphine, Diazepam, Dichloralphenazone, Difenoxin, Dihydrocodeine, Diphenhydramine, Diphenoxylate, Donepezil, Doxylamine, Droperidol
- Enflurane, Estazolam, Eszopiclone, Ethchlorvynol, Ethopropazine, Ethylmorphine
- Fentanyl, Flibanserin, Flunitrazepam, Fluphenazine, Flurazepam, Fluspirilene, Fospropofol
- Halazepam, Haloperidol, Halothane, Hexobarbital, Hydrocodone, Hydromorphone, Hydroxyzine
- Isoflurane
- Ketamine, Ketazolam, Ketobemidone
- Levorphanol, Lorazepam
- Meclizine, Melperone, Meperidine, Mephobarbital, Meprobamate, Meptazinol, Mesoridazine, Metaxalone, Methadone, Methdilazine, Methocarbamol, Methohexital, Methotrimeprazine, Methylene Blue, Methylnaltrexone, Midazolam, Molindone, Moricizine, Morphine, Morphine Sulfate, Liposome
- Nalbuphine, Nalmefene, Nalorphine, Naloxone, Nicomorphine, Nitrazepam, Nitrous Oxide
- Olanzapine, Opium, Opium Alkaloids, Orphenadrine, Oxazepam, Oxycodone, Oxymorphone
- Papaveretum, Paregoric, Pentazocine, Pentobarbital, Perampanel, Perazine, Periciazine, Perphenazine, Phenobarbital, Pimozide, Piperacetazine, Pipotiazine, Piritramide, Prazepam, Primidone, Prochlorperazine, Promazine, Promethazine, Propofol, Propoxyphene
- Quazepam, Quetiapine
- Ramelteon, Remifentanil, Remoxipride
- Samidorphan, Secobarbital, Sertindole, Sodium Oxybate, Sufentanil, Sulpiride, Suvorexant
- Tapentadol, Temazepam, Thiethylperazine, Thiopental, Thiopropazate, Thioridazine, Tilidine, Tizanidine, Tolonium Chloride, Topiramate, Tramadol, Triazolam, Trifluoperazine, Trifluperidol, Triflupromazine, Trimeprazine
- Zaleplon, Zolpidem, Zopiclone, Zotepine.
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.
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's disease (adrenal gland problem) or Brain tumor or CNS depression, history of or Enlarged prostate (BPH, prostatic hypertrophy) or Head injuries or Hypothyroidism (an underactive thyroid) or Kyphoscoliosis (curvature of spine that can cause breathing problems) or Lung or breathing problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia) or Mental illness, history of or Problems with passing urine. Use with Caution.
May increase risk for more serious side effects:
Alcohol abuse, or history of or Drug dependence, especially narcotic abuse or dependence, history of may be more likely to develop. Hypertension (high blood pressure) or Respiratory depression (hypoventilation or slow breathing) .Use with caution.
May make these conditions worse:
Kidney disease or Liver disease ”Use with caution”.
The effects may be increased because of slower removal of the medicine from the body.
It is very important that your doctor check the progress of you or your child while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it. This medicine may be habit-forming. If you or your child feels that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child 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.
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 or your child is 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. If you or your child has been using this medicine regularly for several days, do not suddenly stop using it without first checking with your doctor. You or your child may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects (e.g., abdominal or stomach cramps, fever, runny nose, anxiety, or restlessness).
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.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common:
- Drowsiness
- Relaxed and calm
- Sleepiness
Rare:
- Bleeding, Blistering, Burning, coldness, discoloration of skin
- Feeling of pressure
- Hives
- Infection
- Inflammation
- Itching
- Lumps
- Numbness
- Pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- Blurred vision burning
- Crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Chest pain or discomfort
- Confusion
- Difficult or labored breathing
- Feeling, seeing, or hearing things that are not there
- Feeling that others are watching you or controlling your behavior
- Feeling that others can hear your thoughts
- Headache
- Severe mood or mental changes
- Shortness of breath
- Slurred speech
- Tightness of the chest
- Unusual behavior
- Wheezing
Incidence not known:
- Anxiety
- Cough
- Diarrhea
- Difficulty breathing
- Dry mouth
- Hyperventilation
- Irregular heartbeats
- Irritability
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- Loss of muscle coordination
- Nervousness
- Noisy breathing
- Restlessness
- Seizures
- Shaking
- Trouble sleeping
- Wheezing
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:
Less common:
- Constricted, pinpoint, or small pupils (black part of the eye)
- Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- Extremely shallow or slow breathing
- Sweating
- Vomiting
Rare:
- Burning, dry, or itching eyes
- Chills
- Continuing ringing or buzzing or other unexplained noise in the ears
- Decrease in frequency of urination
- Decrease in urine volume
- Depression
- Difficulty in passing urine (dribbling) discharge,
- Excessive tearing
- Dreaming
- Dry mouth
- False or unusual sense of well-being
- Fast, pounding, or irregular heartbeat or pulse
- Feeling of warmth
- Hearing loss
- Itching of the skin
- Painful urination
- Pounding in the ears
- Redness of the face, neck, arms and occasionally, upper chest redness,
- Pain or swelling of the eye, eyelid, or inner lining of eyelid
- Unusual tiredness or weakness
Incidence not known:
- Acid or sour stomach belching
- Bloated bluish lips or skin
- Change in vision
- Excess air or gas in the stomach or intestines, feeling of unreality full feeling,
- General feeling of discomfort or illness
- Heartburn, hives or welts
- Impaired vision
- Indigestion, loss of appetite
- Not breathing
- Paleness of the skin
- Passing gas
- Redness of the skin
- Sense of detachment from self or body
- Skin rash
- Stomach discomfort, upset, or pain.
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.
