Pronunciation:

bue-TOR-fa-nol

Brand Names:

• Stadol NS

Dosage Forms:

• Spray

Warnings:

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. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental exposure to butorphanol, especially in children, can result in fatal overdose of butorphanol. 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. The concomitant use of butorphanol tartrate with all CYP3A4 inhibitors may result in an increase in butorphanol plasma concentrations, which may cause potentially fatal respiratory depression, and discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in butorphanol plasma concentrations; monitor patients receiving butorphanol tartrate and any CYP3A4 inhibitor or inducer. Concomitant use 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 nasal spray is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. 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 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 under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

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 nasal spray 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 nasal spray 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 liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving butorphanol nasal spray.

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 taking 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
• Oliceridine
• 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, history of or
• Brain tumor, history of or
• Breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Head injuries, history of or
• Heart attack, history of or
• Heart or blood vessel problems or
• Increased pressure in the head or
• Seizures, history of or
• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Gallbladder disease or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Pancreatitis (inflammation or swelling of the pancreas), acute—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 problems, severe (eg, bronchial asthma, respiratory depression) or
• Stomach or bowel blockage (including paralytic ileus), known or suspected—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of butorphanol. This medicine should also come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it into your eyes or on your skin. If it does get on these areas, rinse it off right away.

To use the nasal spray:

• Blow your nose gently to clear the nostrils.
• Take the cap off of the bottle and remove the clip from the neck of the pump.
• If you are using the medicine for the first time, you will need to prime the spray pump.
• To do this, hold the spray bottle with your thumb on the bottom of the bottle and your index and middle fingers on the 2 flaps on the side of the pump.
• Push down with your index and middle fingers. Keep pumping until you see a fine spray from the bottle.
• Put the tip of the spray pump into your nostril.
• Close the other nostril with your finger and lean your head slightly forward.
• Sniff gently and push down on the 2 flaps to spray the medicine into your nose. Keep your mouth closed as you are breathing in.
• Take the spray pump out of your nostril and tilt your head back. Sniff a few more times.

After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For pain:
    • Adults—1 milligram (mg) or 1 spray in one nostril. A second spray may be taken 60 to 90 minutes after the first dose if needed. This may be repeated every 3 to 4 hours as needed.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After you stop using the nasal spray, unscrew the cap, rinse the bottle, and place the parts in a waste container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

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 will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, barbiturates or seizure medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

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. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased. 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

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 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.

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 the serotonin levels in your body.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

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:

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 immediately if any of the following side effects occur:

Less common

Bloody nose

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

cough

cough producing mucus

difficult or labored breathing

ear congestion

fast, irregular, pounding, or racing heartbeat or pulse

feeling faint, dizzy, or lightheaded

feeling of warmth or heat

fever

flushing or redness of the skin, especially on the face and neck

headache

loss of voice

runny nose

shakiness in the legs, arms, hands, or feet

sneezing

sore throat

stuffy nose

sweating

tightness in the chest

trembling or shaking of the hands or feet

unusual tiredness or weakness

Rare

Blurred vision

chest pain

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

shallow breathing

Incidence not known

Agitation

bluish lips or skin

confusion

darkening of the skin

diarrhea

difficulty swallowing

hives, itching, skin rash

loss of appetite

mental depression

nausea

not breathing

overactive reflexes

poor coordination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

seizures

shivering

sweating

talking or acting with excitement you cannot control

tightness in the chest

twitching

vomiting

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

Symptoms of overdose

Change in consciousness

chest pain

choking

cold and clammy skin

constricted, pinpoint, or small pupils (black part of the eye)

coughing that sometimes produces a pink frothy sputum

decreased awareness or responsiveness

difficult, fast, or noisy breathing

extremely shallow or slow breathing

increased sweating

loss of consciousness

no muscle tone or movement

pale skin

severe sleepiness

slow heartbeat

swelling in the legs and ankles

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

Sleepiness or unusual drowsiness

trouble sleeping

Less common

Bad or unusual or unpleasant (after) taste

continuing ringing or buzzing or other unexplained noise in the ears

difficulty having a bowel movement

dry mouth

ear pain

false or unusual sense of well-being

fear or nervousness

floating feeling

hearing loss

lack or loss of strength

pain or tenderness around the eyes and cheekbones

sneezing

stomach pain

tender, swollen glands in the neck

trouble with swallowing

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

voice changes

weight loss

Incidence not known

False beliefs that cannot be changed by facts

feeling of constant movement of self or surroundings

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.