Buprenorphine (Injection route)
Use of buprenorphine hydrochloride increases the risk of opioid addiction, abuse, or misuse, which may cause overdose or death. Assess the risk prior to therapy and monitor for signs of addiction, abuse, or misuse during therapy. Serious, life-threatening, or fatal respiratory depression may occur, particularly at treatment initiation and with dose increases. Monitor for signs of respiratory depression during treatment. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if unnoticed and untreated. If prolonged use is required in a pregnant woman, advise the patient of the risk to the fetus. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
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, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine injection.
|All Trimesters||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.
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.
- Chloral Hydrate
- Methylene Blue
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
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
- Alcohol abuse, or history of or
- Brain tumor or
- CNS depression, history of or
- Congestive heart failure or
- Drug dependence, especially narcotic abuse or dependence, history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Head injuries or
- Heart disease, unstable or
- Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypothyroidism (an underactive thyroid) or
- Kyphoscoliosis (curvature of spine that can cause breathing problems) or
- Lung or breathing problems (eg, 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.
- Gallbladder problems or
- Hypertension (high blood pressure) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of—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.
- Lung or breathing problem, severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
Proper Use of This Medicine:
A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot into a muscle or a vein.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you or your child to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Precautions While Using This Medicine:
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.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.
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 (eg, abdominal or stomach cramps, fever, runny nose, anxiety, or restlessness).
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
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 serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
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.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan 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 of This Medicine:
- More common
- relaxed and calm
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection 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
- 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
- severe mood or mental changes
- slurred speech
- tightness of the chest
- unusual behavior
- Incidence not known
- dry mouth
- irregular heartbeats
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of muscle coordination
- noisy breathing
- trouble sleeping
- More common
- Less common
- Constricted, pinpoint, or small pupils (black part of the eye)
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extremely shallow or slow breathing
- Burning, dry, or itching eyes
- continuing ringing or buzzing or other unexplained noise in the ears
- decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- discharge, excessive tearing
- 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 the eyelid
- unusual tiredness or weakness
- Incidence not known
- Acid or sour stomach
- 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
- hives or welts, skin rash
- impaired vision
- loss of appetite
- not breathing
- paleness of the skin
- passing gas
- redness of the skin
- sense of detachment from self or body
- stomach discomfort, upset, or pain
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 or nurse immediately if any of the following side effects occur:
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:
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.
Last Updated: 9/4/2017