Stadol NS (Nasal)

Butorphanol nasal spray is used to relieve pain that is severe enough to need opioid treatment and when other pain medicines haven't worked well or cannot be tolerated. It is part of a group of medicines known as narcotic analgesics (pain medicines). Butorphanol works on the central nervous system (CNS) to relieve pain.

Using butorphanol for a long time may lead to habit-forming behavior, causing mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to happen when narcotics are used for this purpose. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, serious withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping treatment completely.

This medicine is only available through a restricted program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your progress while you are using this medicine, especially during the first 24 to 72 hours of treatment. This will help your doctor determine if the medicine is working well and if you should keep using it. You may need blood and urine tests to check for negative effects.

Signs of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor immediately if you notice any of these symptoms.

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

This medicine may lead to dependence. If you feel that the medicine is not working as effectively, do not take more than your prescribed dose. Call your doctor for guidance.

You may experience dizziness, lightheadedness, or fainting when you get up quickly from lying down or sitting. These symptoms are more likely when you start using this medicine or when your dose is increased. Getting up slowly may help reduce this issue. Also, lying down for a while may ease dizziness or lightheadedness.

This medicine may cause dizziness, drowsiness, or lightheadedness. 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 needs immediate medical help. 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 using this medicine.

Using narcotics for a long time can lead to severe constipation. To avoid this, your doctor may recommend taking laxatives, drinking plenty of fluids, or increasing your dietary fiber. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious issues.

Do not change your dose or stop using this medicine suddenly without first talking to your doctor. Your doctor may want you to gradually reduce your dosage before stopping completely. This can help prevent worsening of your condition and lower the chance of withdrawal symptoms, such as abdominal cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Contact your doctor immediately if you experience anxiety, restlessness, a rapid heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may increase if you are also taking certain other medicines that affect serotonin levels in your body.

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

Taking excessive amounts of this medicine may cause infertility (the inability to have children). Discuss with your doctor before using this medicine if you intend to have children.

Do not take other medicines unless you have talked with your doctor about them. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medication, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medications. Also inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of butorphanol nasal spray in the elderly. However, elderly patients may be more sensitive to the effects of this medication than younger adults, and are more likely to have age-related liver, kidney, heart, or lung issues, 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 chances prior to taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially important that your healthcare professional know if you are using 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 medication with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following drugs is usually not advised, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• 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

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications may additionally 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 normally not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently 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 medication. Make sure you inform your physician if you have any other medical problems, especially:

• Adrenal issues 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 issues or
• Increased pressure in the head or
• Seizures, history of or
• Weakened physical condition—Use with caution. May increase chance for more serious adverse 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 since of slower removal of the medicine from the body.

• Lung or breathing problems, severe (eg, bronchial asthma, respiratory depression) or
• Stomach or bowel blockage (such as paralytic ileus), known or suspected—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, 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, 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.

In the U.S.

• Stadol NS

Available Dosage Forms:

• Spray

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

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.