Brand Name(s):

Stadol^® NS¶

IMPORTANT WARNING

Butorphanol nasal spray may be habit forming, especially with prolonged use. Use butorphanol nasal spray exactly as directed. Do not use more of it, use it more often, or use it in a different way than directed by your doctor. While using butorphanol nasal spray, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse butorphanol if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Butorphanol nasal spray may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use butorphanol nasal spray. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications with butorphanol nasal spray may increase the risk of serious or life-threatening breathing problems. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); carbamazepine (Carbatrol, Epitol, Tegretol, Teril); medications for anxiety, mental illness or nausea; benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); clarithromycin (Biaxin, in PrevPac)muscle relaxants; erythromycin (Erytab, Erythrocin); certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); other narcotic pain medications; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medication and will monitor you carefully.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with butorphanol nasal spray also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you use butorphanol nasal spray regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Butorphanol nasal spray is used to relieve moderate to severe pain. Butorphanol is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.

HOW should this medicine be used?

Butorphanol nasal spray comes as a solution (liquid) to spray in the nose. It is usually used as needed for pain but not more often than once every 3 to 4 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Butorphanol nasal spray should relieve your pain soon after you use it. If you are using a low starting dose of butorphanol nasal spray, your doctor may tell you that you may use a second dose if you still have pain 60 to 90 minutes after your first dose. Do not use this second dose unless your doctor tells you that you may. Call your doctor if you still have pain after using butorphanol nasal spray as prescribed. Also call your doctor if you have used butorphanol nasal spray for some time and find that it no longer works as well as it did at the beginning of your treatment.

Do not stop using butorphanol nasal spray without talking to your doctor. If you suddenly stop using butorphanol nasal spray, you may experience withdrawal symptoms such as nervousness, agitation, shakiness, diarrhea, chills, sweats, difficulty falling asleep or staying asleep, loss of coordination,confusion, or hallucinations (seeing things or hearing voices that do not exist). Your doctor will probably decrease your dose gradually.

Before you use butorphanol nasal spray for the first time, read the written directions provided by the manufacturer. Ask your doctor or pharmacist if you have any questions about how to use butorphanol nasal spray.

To use butorphanol nasal spray, follow these directions:

Wash your hands.
Gently blow your nose.
Remove the clear cover and protective clip from the bottle.
If you are using a new pump or a pump that has not been used in 48 hours or longer, you must prime the pump before use. Hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom. Be sure that the bottle is aimed away from you, other people, and animals. Pump the bottle firmly and quickly (up to 8 strokes) until a fine spray appears.
Insert the tip of the sprayer approximately 1/4 inch (0.6 cm) into one nostril, pointing the tip toward the back of your nose.
Close your other nostril with your finger and tilt your head slightly forward.
Pump the spray firmly and quickly one time and sniff gently with your mouth closed.
Remove the sprayer from your nose. Tilt your head backward and sniff gently for a few seconds.
Replace the protective clip and cover on the spray bottle. Put the bottle back in the child-resistant storage container.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) to obtain the Medication Guide.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using butorphanol nasal spray,

tell your doctor and pharmacist if you are allergic to butorphanol, any other medications, or benzethonium chloride (a preservative found in some medications and personal care products). Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, or secobarbital (Seconal); cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nasal sprays such as oxymetazoline (Afrin, Dristan, others); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), and milnacipran (Savella), venlafaxine (Effexor); theophylline (Theochron, Uniphyl, others); trazodone (Oleptro); and tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with butorphanol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or a blockage in your stomach or intestine such as a paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use butorphanol nasal spray.
tell your doctor if you have or have ever had problems urinating; a heart attack; seizures; high blood pressure; or pancreas, gallbladder, thyroid, heart, kidney, or liver disease.
tell your doctor if you are breastfeeding.
you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using butorphanol.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using butorphanol nasal spray.
you should know that butorphanol nasal spray may cause drowsiness, dizziness, or fainting, especially during the first hour after you use the medication. Be sure that you have a comfortable place available in case you need to lie down after you use the medication. Do not drive a car or operate machinery for at least 1 hour after using butorphanol nasal spray. After 1 hour has passed, do not drive until you are sure that you are not dizzy, drowsy, or less alert than usual.
you should know that butorphanol nasal spray may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using butorphanol nasal spray.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Butorphanol nasal spray is usually used as needed. If your doctor has told you to use butorphanol nasal spray regularly, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Store butorphanol nasal spray in its child-resistant container, tightly closed and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of butorphanol nasal spray as soon as it becomes outdated or is no longer needed by unscrewing the cap, rinsing the bottle, and placing the parts in the waste container.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While using butorphanol nasal spray, you may be told to always have a rescue medication called naloxone available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. You will probably be unable to treat yourself if you experience an opiate overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to tell if you are experiencing an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If someone sees that you are experiencing symptoms of an overdose, he or she should give you your first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

slow or shallow breathing
coma (loss of consciousness for a period of time)
death

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to butorphanol.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using butorphanol.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2018.