Butorphanol Nasal Spray

The dose depends on your response to the medication.** The usual recommended adult dose for starting nasal therapy is one spray in one nostril (1 mg).** A repeat dose may be allowed if there is inadequate pain relief within 60 to 90 minutes of the initial dose.

This dosing sequence can be repeated every 3 to 4 hours as needed for pain relief. The dose may be increased as directed by your doctor, but doses of more than 16 mg daily are not normally recommended. The effectiveness of butorphanol for periods longer than 3 days has not been established.

For people who experience more severe pain, their doctor may prescribe an initial dose of one spray in each nostril. If this is the case, ensure there is a place for you to lie down, as drowsiness or dizziness may occur. The next dose should not be used for 3 or 4 hours. Seniors and those with kidney or liver damage may require different dosing as prescribed by their doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

This medication may be habit-forming if taken for long periods of time. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important to use this medication exactly as prescribed by your doctor. Do not take more of this medication than your doctor has recommended. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, with the protective clip and dust cover on. Keep it out of the reach of children. Accidental ingestion of this medication, especially by children, can have severe and even fatal consequences.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of clear, colourless aqueous solution contains 10 mg of butorphanol tartrate. Nonmedicinal ingredients: 0.2 mg/mL benzethonium chloride as a preservative, citric acid, purified water with hydrochloric acid and sodium hydroxide.

Do not use this medication if you:

• are allergic to butorphanol or any ingredients of the medication

• have mild to moderate pain that can be controlled with other medications

• have a blockage in the digestive system or narrowing of the stomach or intestines

• are experiencing sudden, severe, abdominal pain that may require surgery (surgical abdomen)

• have severe breathing problems or severe obstructive lung problems (e.g., chronic bronchitis, emphysema)

• are experiencing decreased, shallow breathing

• are currently taking or have taken a MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 14 days

• are experiencing acute alcoholism, delirium tremens or have a seizure disorder

• have severe central nervous system (CNS) depression (e.g., slowed nervous system), increased pressure in the brain or a head injury

• are pregnant or breast-feeding

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain

• appetite changes (increase or decrease)

• constipation

• decreased ability or interest in sexual activity

• dizziness

• drowsiness

• dry mouth

• ear problems (e.g., ear pain, ringing in the ears, increased sensitivity to sound)

• feeling cold

• fever

• gas

• headache

• irritation inside nose

• itchiness

• loss of sense of taste

• nausea

• sweating

• trouble sleeping

• weakness (severe)

• vivid imagination or dreams

• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision

• confusion

• decreased coordination

• difficulty urinating

• false sense of well-being

• fast, slow, or irregular heartbeat

• hallucinations (e.g., hearing or seeing things that aren't there)

• irritability

• low blood pressure (e.g., dizziness, fainting, lightheadedness when rising from a sitting or lying position)

• memory problems

• signs of allergy (e.g., skin rash or hives)

• signs of breathing problems (e.g., shortness of breath, wheezing, irregular or troubled breathing)

• symptoms of bowel blockage (e.g., abdominal pain, severe constipation, nausea)

• symptoms of high blood pressure (e.g., shortness of breath, fatigue, dizziness, chest pain or pressure, bluish colour to lips and skin, racing heartbeat)

• symptoms of withdrawal (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, loss of appetite, sweating)

Stop taking the medication and seek medical attention immediately if any of the following occur:

• convulsions (seizures)

• signs of too much butorphanol; overdose:

  • cold, clammy skin

  • low blood pressure

  • pinpoint pupils of eyes

  • severe drowsiness, weakness

  • severe nervousness or restlessness

  • slow heartbeat

  • slow or weak breathing

• signs of a serious allergic reaction:

  • abdominal cramps

  • difficulty breathing

  • nausea and vomiting

  • swelling of the face and throat

• slow or troubled breathing

• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: Butorphanol, like other narcotic medications, can cause constipation. It may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have stomach problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Accidental Use: **When butorphanol nasal spray is used by anyone other than the person for whom it was prescribed, it can have dangerous and even fatal side effects.  Keep this medication out of sight and reach of children.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including how your body responds to injury or stress. When used for longer periods of time, butorphanol may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

**Alcohol and other medications that cause drowsiness: **Alcohol increases the risk of severe side effects from butorphanol, such as breathing problems and severe drowsiness. Consuming alcohol while you are taking butorphanol is not recommended. Other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications) should be avoided if possible, as additive side effects may occur and can be dangerous and potentially fatal.

Breathing: Butorphanol can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of butorphanol. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication.

Abuse is not a problem with people who require this medication for pain relief. If you suddenly stop taking this medication, you may experience withdrawal symptoms such as anxiety, agitation, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

**Dizziness: **Butorphanol can cause severe dizziness, especially when rising from a sitting or lying position. This is more likely to occur within the first hour of butorphanol being used or when other medications with similar side effects are being taken. People taking medications that can cause dizziness should rise slowly from sitting or lying down to reduce the possibility of severe dizziness or fainting.

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Head injury: If you have had a head injury or have increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of your condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Decreased kidney function can cause a buildup of butorphanol in the body, resulting in more severe side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Liver function: **Decreased liver function can cause a buildup of butorphanol in the body, resulting in more severe side effects. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Butorphanol can cause low blood pressure or make low blood pressure worse. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

Serotonin Syndrome: Severe reactions are possible when butorphanol is combined with medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations can cause an increase in the amount of serotonin in the body. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Butorphanol crosses the placental barrier and can cause harm to the developing baby if it is used by the mother during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. Withdrawal symptoms have been noted in newborns of mothers who used butorphanol during pregnancy.

**Breast-feeding: **This medication may pass into breast milk. If you are a breast-feeding mother and are using butorphanol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children and adolescents under 18 years of age.

Seniors: Seniors may be more sensitive to the side effects of butorphanol, particularly dizziness.

There may be an interaction between butorphanol and any of the following:

• acetazolamide

• aclidinium

• alcohol

• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)

• anaesthetics

• antihistamines (e.g., azelastine, bilastine, cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine, rupatadine)

• antipsychotic medications (e.g., aripiprazole, cariprazine, haloperidol, olanzapine, quetiapine, risperidone)

• apalutamide

• atropine

• barbiturates (e.g., butalbital, phenobarbital)

• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)

• benztropine

• brimonidine

• buprenorphine

• cannabis

• ceritinib

• chloral hydrate

• clidinium

• clonidine

• cobicistat

• darifenacin

• desmopressin

• diphenoxylate

• disopyramide

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• domperidone

• efavirenz

• entacapone

• enzalutamide

• eplerenone

• ergot alkaloids (e.g., ergotamine, dihydroergotamine)

• esketamine

• fesoterodine

• flibanserin

• flunarizine

• gabapentin

• glycopyrrolate

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• idelalisib

• ipratropium

• itraconazole

• kava kava

• ketoconazole

• ketotifen

• lemborexant

• linezolid

• lithium

• methadone

• metoclopramide

• mifepristone

• mirtazapine

• MAO inhibitors (e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)

• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)

• nabilone

• naloxone

• naltrexone

• other narcotic medications (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)

• oxybutynin

• pegvisomant

• pramipexole

• pregabalin

• quinidine

• rifampin

• ropinirole

• rotigotine

• St. John's wort

• seizure medications (e.g., carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, phenytoin, primidone, topiramate)

• selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)

• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)

• solifenacin

• somatostatin-like medications (e.g., lanreotide, octreotide, pasireotide)

• spironolactone

• stiripentol

• tetrabenazine

• thalidomide

• theophylline

• tiotropium

• tolterodine

• trazodone

• tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)

• trihexyphenidyl

• trospium

• tryptophan

• umeclidinium

• valerian

• zolpidem

• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Butorphanol-Nasal-Spray