FDA Drug Safety Communication:
- As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
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 has had an overdose, 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, brain tumor, 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 medication 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.
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 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 medication cause?
Butorphanol nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- excessive tiredness
- difficulty falling asleep or staying asleep
- unusual dreams
- stomach pain
- feeling hot
- pain, burning, numbness, or tingling in the hands or feet
- uncontrollable shaking of a part of the body
- intense happiness
- feeling of floating
- feeling of sadness, unpleasantness, or discomfort
- blurred vision
- ringing in the ears
- ear pain
- unpleasant taste
- dry mouth
- difficulty urinating
- stuffy or irritated nose
- sore throat
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- slowed breathing
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- difficulty breathing
- irregular or pounding heartbeat
Butorphanol nasal spray may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
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
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://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 should talk to your doctor about having a rescue medication called naloxone readily 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. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize 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 symptoms of an overdose occur, a friend or family member should give the 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
- difficulty breathing
- unable to respond or wake up
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.
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¶ This branded product is no longer on the market. Generic alternatives may be available.