Butorphanol (Injection route)
Butorphanol tartrate has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Prolonged use of butorphanol tartrate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of opioids with benzodiazepines or other CNS depressants including alcohol, 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:
Butorphanol injection is used to relieve pain. It may also be given before a surgery, when giving birth, or with general anesthesia before an operation. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain.
When butorphanol 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 to be given only by or under the direct supervision of your doctor.
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 butorphanol 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 butorphanol 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 lung, kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving butorphanol injection in order to avoid serious side effects.
|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.|
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.
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, or history of or
- Brain tumor or
- Breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia, apnea) or
- Drug dependence, especially narcotic abuse, history of or
- Head injuries or
- Heart attack or
- Heart or blood vessel problems or
- Increased pressure in the head—Use with caution. May increase risk for more serious side effects.
- Heart attack or
- Heart or blood vessel problems or
- Hypertension (high blood pressure)—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.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle or through a needle placed in one of your veins.
Precautions While Using This Medicine:
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 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.
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.
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.
Your doctor may want you to gradually reduce the amount you are using 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.
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:
- Less common
- Cough producing mucus
- difficulty breathing
- shortness of breath
- tightness in chest
- Blurred vision
- chest pain
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fast, pounding, or irregular heartbeat or pulse
- pounding in the ears
- slow or fast heartbeat
- Incidence not known
- Bluish lips or skin
- false beliefs that cannot be changed by facts
- not breathing
- Symptoms of overdose
- Change in consciousness
- extremely shallow or slow breathing
- irregular heartbeats
- loss of consciousness
- shortness of breath
- swelling in hands and feet
- More common
- sleepiness or unusual drowsiness
- Less common
- Bad unusual or unpleasant (after) taste
- bloody nose
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- clammy skin
- continuing ringing or buzzing or other unexplained noise in ears
- dry mouth
- dryness or soreness of throat
- ear pain
- false or unusual sense of well-being
- fear or nervousness
- feeling of warmth or heat
- floating feeling
- flushing or redness of skin, especially on face and neck
- hearing loss
- heat sensation on body
- loss of appetite
- nasal irritation
- runny nose
- skin itching
- stomach pain
- stuffy nose
- tender, swollen glands in neck
- trouble in swallowing
- trouble sleeping
- unable to sleep
- voice changes
- weight loss
- unusual tiredness or weakness
- Incidence not known
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- lack or loss of strength
- problems in speaking
- sensation of spinning
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:
Get emergency help immediately if any of the following symptoms of overdose 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: 8/2/2019