Stadol : 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 (Butorphanol injection) can be habit-forming, especially with long-term use. Use Stadol 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, talk with your healthcare provider about your pain management goals, the 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) 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 can cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and whenever 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. 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 Stadol 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: 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); muscle relaxants; other narcotic pain relievers; 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 illicit drugs during your treatment with Stadol 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 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 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 (Butorphanol injection) is used to relieve moderate to severe pain. Stadol is also used to relieve pain during labor and to prevent pain and decrease consciousness before or during surgery. 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 comes as a liquid to be injected into a muscle or vein. When Stadol is used for pain relief, it is usually given once every 3 to 4 hours as needed. When Stadol is used to relieve pain during surgery, it can be given 60 to 90 minutes before surgery and then as needed during surgery. When Stadol is used to relieve pain during labor, it can be given once every 4 hours, but should not be given less than 4 hours before your due date.

You may receive a Stadol in a hospital, or you may be given the medicine to use at home. If you have been told to give yourself Stadol at home, it is very important that you use the medicine exactly as directed. Follow the instructions you are given carefully and ask your doctor, pharmacist or nurse if you have any questions or do not understand the instructions.

If you have been told to use Stadol at home, do not stop using the medication without talking to your doctor. If you stop using Stadol suddenly, you may experience withdrawal symptoms such as nervousness, agitation, tremors, diarrhea, chills, sweating, trouble falling or staying asleep, confusion, loss of coordination, or hallucinations (seeing things or hearing voices. nonexistent). Your doctor will likely reduce your dose gradually.

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,

Tell your doctor and pharmacist if you are allergic to Stadol, any other medications, or the ingredients in Stadol. Ask your pharmacist 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 medicines; in Nuedexta); erythromycin (E.E.S., Eryc, Erythrocin, others); medications for seizures; 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); 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), milnacipran (Savella), and venlafaxine (Effexor); or tricylic antidepressants (‘mood elevators’) such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimilipramine (Surmonipramine); theophylline (Theochron, Uniphyl, others); and trazodone (Oleptro). 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), 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 or tryptophan.
Tell your doctor if you have or have ever had trouble urinating; a heart attack; hypertension; or heart, kidney, or liver disease.
Tell your doctor if you are breastfeeding. Some women using Stadol may have higher amounts of the drug in their breast milk, which can cause serious or life-threatening side effects in their breastfed babies. You should also call your baby’s doctor or seek emergency help if your baby is more sleepy than usual, has trouble breastfeeding or breathing, or becomes flabby.
You should know that this medicine can decrease fertility in men and women. Talk to your doctor about the risks of using Stadol.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are using Stadol.
You should know that Stadol may make you drowsy and dizzy. Do not drive a car or operate machinery for at least one hour after receiving a dose. After an hour, don’t drive until you’re sure you’re not dizzy, sleepy, or less alert than usual.

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 is usually used as needed. If your doctor has told you to use Stadol 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 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
headache
constipation
stomach pain
feeling hot
flushing
pain, burning, numbness, or tingling in the hands or feet
uncontrollable shaking of a part of your body
nervousness
hostility
intense happiness
feeling of floating
sad mood
blurred vision
ringing in the ears
ear pain
unpleasant taste
dry mouth
difficulty urinating

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNINGS section, call your doctor immediately or get emergency medical attention:

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
changes in heartbeat
fainting
rash
hives

Stadol 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?

If you are using Stadol at home, keep the medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medicine that is out of date or no longer needed. Talk to your pharmacist about the correct way to dispose of your medicine.

Store Stadol in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medicine is left to see if any are missing.

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, 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).

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

Do not let anyone use your medicine. If you continue to have pain after you finish your Stadol, call your doctor.

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^®

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.