Butorphanol (Injection route)

Pronunciation:

bue-TOR-fa-nol

Brand Names:

Stadol

Dosage Forms:

Solution

Warnings:

Injection route(Solution)

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 .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Opioid Agonist/Antagonist

Chemical—

Opioid

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:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

Nalmefene
Naltrexone
Safinamide
Samidorphan

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
Almotriptan
Alprazolam
Amifampridine
Amineptine
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Aripiprazole
Asenapine
Baclofen
Benperidol
Benzhydrocodone
Benzphetamine
Bromazepam
Bromopride
Brompheniramine
Buprenorphine
Bupropion
Buspirone
Butabarbital
Calcium Oxybate
Cannabidiol
Cannabis
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Citalopram
Clobazam
Clomipramine
Clonazepam
Clopidogrel
Clorazepate
Clozapine
Cocaine
Codeine
Daridorexant
Desipramine
Desmopressin
Desvenlafaxine
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Doxepin
Droperidol
Duloxetine
Eletriptan
Enflurane
Escitalopram
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fenfluramine
Fentanyl
Flibanserin
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fospropofol
Frovatriptan
Furazolidone
Gabapentin
Gabapentin Enacarbil
Gepirone
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Hydroxyzine
Iproniazid
Isocarboxazid
Isoflurane
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Lasmiditan
Lemborexant
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lorazepam
Lorcaserin
Loxapine
Magnesium Oxybate
Meclizine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Metoclopramide
Midazolam
Milnacipran
Mirtazapine
Moclobemide
Molindone
Moricizine
Morphine
Nalbuphine
Naratriptan
Nefazodone
Nialamide
Nicomorphine
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Ozanimod
Palonosetron
Papaveretum
Paregoric
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Potassium Oxybate
Prazepam
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propofol
Protriptyline
Quazepam
Quetiapine
Ramelteon
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Rizatriptan
Ropeginterferon Alfa-2b-njft
Scopolamine
Secobarbital
Selegiline
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
St John's Wort
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Tranylcypromine
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Venlafaxine
Vilazodone
Vortioxetine
Zaleplon
Ziprasidone
Zolpidem
Zopiclone
Zotepine
Zuranolone

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:

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:

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:

Less common: Cough producing mucus; difficulty breathing; shortness of breath; tightness in chest; wheezing

Rare: Blurred vision; chest pain; confusion; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; fast, pounding, or irregular heartbeat or pulse; nervousness; 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; seizures

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Change in consciousness; extremely shallow or slow breathing; irregular heartbeats; loss of consciousness; shortness of breath; swelling in hands and feet

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: Dizziness; nausea; sleepiness or unusual drowsiness; vomiting

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; congestion; continuing ringing or buzzing or other unexplained noise in ears; cough; dry mouth; dryness or soreness of throat; ear pain; false or unusual sense of well-being; fear or nervousness; feeling of warmth or heat; fever; floating feeling; flushing or redness of skin, especially on face and neck; headache; hearing loss; heat sensation on body; hoarseness; loss of appetite; nasal irritation; runny nose; shakiness; skin itching; sleeplessness; sneezing; stomach pain; stuffy nose; tender, swollen glands in neck; trouble in swallowing; trouble sleeping; unable to sleep; voice changes; weight loss

Rare: Sweating; 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

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: 11/16/2023

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