Stadol NS : Uses, Side Effects, Interactions & More

Notice:

TOPIC: Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert – FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing.

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides, available at: https://bit.ly/3hzDavc, will also be updated.

BACKGROUND: Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.

The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, available at: https://bit.ly/3hx8tXG, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.

RECOMMENDATION:

Patients:

Talk to your health care professionals about the benefits of naloxone and how to obtain it.
Recognize the signs and symptoms of a possible opioid overdose. These include slowed, shallow, or difficult breathing, severe sleepiness, or not being able to respond or wake up. If you know or think someone is overdosing, give the person naloxone if you have access to it, and always call 911 or go to an emergency room right away. Naloxone is a temporary treatment, so repeat doses may be required. Even if you give naloxone, you still need to get emergency medical help right away.
If you have naloxone, make sure to tell your caregivers, household members, and other close contacts that you have it, where it is stored, and how to properly use it in the event of an overdose. When using opioid medicines away from home, carry naloxone with you and let those you are with know you have it, where it is, and how to use it. Read the Patient Information leaflet or other educational material and Instructions for Use that comes with your naloxone because it explains important information, including how to use the medicine.

Health Care Professionals:

Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.
Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose.
Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.
Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state, available at: https://www.usa.gov/state-health, dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

IMPORTANT WARNING:

Stadol NS (Butorphanol nasal spray) can be habit-forming, especially with long-term use. Use Stadol NS exactly as directed. Do not use it more, use it more often, or use it in a way other than that directed by your doctor. While using Stadol NS, talk with your healthcare provider about your pain management 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 had large amounts of alcohol, uses or has ever used illegal drugs, or has overused prescription drugs, or if you have or have ever had depression or other Mental illness. There is an increased risk that you will overuse butorphanol (Stadol NS) if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and seek guidance if you think 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.

Stadol NS can cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and each time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slow breathing or asthma. Your doctor will probably tell you not to use Stadol NS. Also tell your doctor if you have or have ever had a 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 on the brain. Your risk of developing breathing problems may be higher if you are an older adult or weak or malnourished due to illness. If you experience any of the following symptoms, call your doctor immediately or seek emergency medical treatment: slow breathing, long pauses between breaths, or difficulty breathing.

Taking certain other medications with a Stadol NS can 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 such as 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 (Halcion), and triazolam (Halcion); clarithromycin muscle relaxants (Biaxin, in PrevPac); erythromycin (Erytab, Erythrocin); certain medications for the human immunodeficiency virus (HIV), including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); other narcotic pain relievers; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampicin (Rifadin, Rimactane, in Rifamate); sedative sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medicine and will monitor you carefully.

Drinking alcohol, taking prescription or over-the-counter medications that contain alcohol, or using illegal drugs during your treatment with Stadol NS also increases the risk that you will experience these serious and life-threatening side effects. Do not drink alcohol or use illegal drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you use Stadol NS 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 crying, uncontrollable shaking of part of the body, vomiting, diarrhea, or lack of weight gain.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with Stadol NS 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?

Stadol NS (Butorphanol nasal spray) is used to relieve moderate to severe pain. Butorphanol is in a class of medications called opioid agonists-antagonists. It works by changing the way the body feels pain.

How should this medicine be used?

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

Stadol NS should relieve your pain shortly after you use it. If you are using a low starting dose of Stadol NS, your doctor may tell you that you can 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 you can. Call your doctor if you still have pain after using Stadol NS as prescribed. Also call your doctor if you have used Stadol NS 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 Stadol NS without talking to your doctor. If you stop using Stadol NS suddenly, you may experience withdrawal symptoms such as nervousness, agitation, tremors, diarrhea, chills, sweating, difficulty falling or staying asleep, loss of coordination, confusion, or hallucinations (seeing things or hearing voices that do not exist). Your doctor will likely reduce your dose gradually.

Before using Stadol NS for the first time, read the written instructions provided by the manufacturer. Ask your doctor or pharmacist if you have any questions about how to use Stadol NS.

To use Stadol NS, follow these directions:

Wash your hands.
Blow your nose gently.
Remove the clear cap and protective clip from the bottle.
If you are using a new pump or a pump that has not been used for 48 hours or more, you must prime the pump before use. Hold the bottle so that the nozzle is between your forefinger and second finger and thumb at the bottom. Make sure the bottle is not facing 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 about 1/4 inch (0.6 cm) into one nostril, pointing the tip toward the back of your nose.
Close the other nostril with your finger and tilt your head slightly forward.
Pump the spray firmly and quickly once and sniff gently with your mouth closed.
Remove the spray from your nose. Tilt your head back and sniff gently for a few seconds.
Replace the protective clip and cap 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 start treatment with Stadol NS and each time you get a refill. 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 Stadol NS,

Tell your doctor and pharmacist if you are allergic to butorphanol (Stadol NS), any other medications, or benzethonium chloride (a preservative found in some medications and personal care products). Ask your pharmacist or see the Medication Guide for a list of 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 medicines; in Nuedexta); lithium (Lithobid); medications for migraines 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. 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 in the last two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine ( Nardil). , selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate). Many other medications can also interact with butorphanol (Stadol NS), 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 closely 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 paralytic ileus (condition in which digested food does not move through the intestines) . Your doctor may tell you not to use Stadol NS.
Tell your doctor if you have or have ever had trouble urinating; a heart attack; hypertensive seizures; or disease of the pancreas, gallbladder, thyroid, heart, kidney, or liver.
Tell your doctor if you are breastfeeding.
You should know that this medicine can decrease fertility in men and women. Talk to your doctor about the risks of using butorphanol (Stadol NS).
If you are having surgery, including dental surgery, tell the doctor or dentist that you are using Stadol NS.
You should know that Stadol NS can cause drowsiness, dizziness, or fainting, especially during the first hour after using the medicine. Make sure you have a comfortable place available in case you need to lie down after using the medicine. Do not drive a car or operate machinery for at least 1 hour after using Stadol NS. After 1 hour has passed, do not drive until you are sure you are not dizzy, drowsy, or less alert than usual.
You should know that Stadol NS can cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while using Stadol NS.

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?

Stadol NS is usually used as needed. If your doctor has told you to use Stadol NS regularly, use the missed dose as soon as you remember. 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 the one you forgot.

What side effects can this medication cause?

Stadol NS may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

drowsiness
excessive tiredness
difficulty falling asleep or staying asleep
unusual dreams
constipation
stomach pain
feeling hot
flushing
pain, burning, numbness, or tingling in the hands or feet
uncontrollable shaking of a part of the body
nervousness
hostility
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
nosebleed
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
fainting
irregular or pounding heartbeat
headache
lightheadedness
rash
hives

Stadol NS may cause other side effects. Call your doctor if you have any unusual problems while using this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (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 Stadol NS in its child-resistant container, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of Stadol NS as soon as it is out of date or no longer needed by unscrewing the cap, rinsing the bottle, and placing the parts in the waste container.

It is important to keep all medicines out of the sight and reach of children, as many containers (such as those containing weekly pills and those for eye drops, creams, patches, and inhalers) are not child-resistant and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright 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 collapsed, had a seizure, has trouble breathing, or cannot wake up, immediately call 911 for emergency services.

While using Stadol NS, you may be told to always have a rescue medicine called naloxone available (for example, at home, in the office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opioids to relieve dangerous symptoms caused by high levels of opiates in the blood. You will probably not be able to treat yourself if you experience an opioid overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to know if you are experiencing an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will teach you and your family members how to use the medicine. Ask your pharmacist for instructions or visit the manufacturer’s website for instructions. If someone sees that you are experiencing symptoms of an overdose, they should give you your first dose of naloxone, call 911 immediately, stay with you, and monitor you closely until emergency medical help arrives. Your symptoms may return within minutes after receiving naloxone. If their symptoms return, the person should give them another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms reappear 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 laboratory tests to check your body’s response to butorphanol (Stadol NS).

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

Don’t let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

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

Brand Names

Stadol^® NS

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.