Nalbuphine (Injection route)
Serious, life-threatening, or fatal respiratory depression may occur with use of nalbuphine, particularly when used concomitantly with other opioids or central nervous system depressants. Monitor for respiratory depression, especially during initiation of nalbuphine or following a dose increase. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of nalbuphine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .
Uses of This Medicine:
Nalbuphine injection is used to relieve moderate to severe pain. It may also be given before and after a surgery or with a general anesthesia before an operation. It may also be used to relieve pain while giving birth.
Nalbuphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
When a nalbuphine injection 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 have not been performed on the relationship of age to the effects of nalbuphine injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Nubain® in the elderly. However, elderly patients are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
No information is available on the relationship of age to the effects of nalbuphine injection in geriatric patients.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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:
- Adrenal problems or
- Alcohol abuse, history of or
- Brain tumor or
- Breathing or lung problems (eg, COPD, cor pulmonale, hypercapnia) or
- Depression, or history of or
- Drug dependence, especially narcotic abuse or dependence, or history of or
- Head injury, history of or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Bradycardia (slow heartbeat) or
- Gallbladder problems or
- Heart attack or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, or history of—Use with caution. May make these conditions worse.
- Breathing or lung problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin or into a muscle a vein.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.
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.
Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.
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 dizziness or lightheadedness.
This medicine may make you dizzy, drowsy, or lightheaded. 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.
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 change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want to gradually reduce the amount of medicine given to you before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
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 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.
Side Effects of This Medicine:
- Chest pain or discomfort
- difficult or labored breathing
- difficulty swallowing
- false beliefs that cannot be changed by facts
- fast, pounding, or irregular heartbeat or pulse
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- redness of the face, neck, arms and occasionally, upper chest
- seeing, hearing, or feeling things that are not there
- sense of detachment from self or body
- shortness of breath
- slow or irregular heartbeat
- Incidence not known
- Blue lips and fingernails
- coughing that sometimes produces a pink frothy sputum
- decrease in consciousness
- difficult, fast, or noisy breathing, sometimes with wheezing
- fear or nervousness
- increased sweating
- loss of bladder control
- muscle spasm or jerking of all extremities
- pale skin
- shakiness in legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- stomach pain
- sudden loss of consciousness
- swelling in legs and ankles
- trembling or shaking of hands or feet
- More common
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- relaxed and calm
- sensation of spinning
- sweaty, clammy skin
- Less common
- Dry mouth
- Acid or sour stomach
- aggressive or angry
- blurred vision
- changes in speech
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- excessive crying
- false or unusual sense of well-being
- feeling of heaviness
- feeling of warmth
- feeling sad or empty
- floating feeling
- frequent strong or increased urge to urinate
- hives or welts
- itching of skin
- lack of appetite
- loss of interest or pleasure
- pounding in the ears
- skin rash
- slow or fast heartbeat
- stomach discomfort, upset, or pain
- trouble concentrating
- trouble sleeping
- tingling feeling of unreality
- unusual tiredness or weakness
- Incidence not known
- 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 site
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