Butorphanol Injection

Butorphanol injection may be habit forming. Use butorphanol injection exactly as directed. Do not use more or less of it, use it more often, stop using it suddenly, or use it in a different way than directed by your doctor. 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.

Butorphanol injection 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. 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.

Butorphanol injection may harm or cause death to other people who use your medication, especially children. Keep butorphanol injection in a safe place so that no one else can take it accidentally or on purpose.

Taking certain other medications, drinking alcohol, or using street drugs with butorphanol injection may increase the risk of serious or life-threatening breathing problems. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medication and will monitor you carefully.

Tell your doctor if you are pregnant or plan to become pregnant. If you use butorphanol injection regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Your doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of using butorphanol injection for your condition.

Butorphanol injection is used to relieve severe pain. Butorphanol injection is also used to relieve pain during labor and to prevent pain and decrease awareness before or during surgery. Butorphanol is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.

Butorphanol injection comes as a solution (liquid) to be injected into a muscle or vein. Inject to relieve pain once every 3 to 4 hours as needed. Give 60 to 90 minutes before surgery and then as needed during the surgery. Give to relieve pain during labor once every 4 hours, but do not give less than 4 hours before delivery is expected.

You may receive butorphanol injection in a hospital, or you may be given the medication to use at home. If you have been told to administer butorphanol injection at home, it is very important that you use the medication exactly as directed.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while using butorphanol. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available over the counter or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

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

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

Before using butorphanol injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with butorphanol. Make sure you have discussed any medications you are currently taking or plan to take before receiving butorphanol with your doctor and pharmacist. Before starting, stopping, or changing any medications while receiving butorphanol, please get the advice of your doctor or pharmacist.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.
• the following nonprescription or herbal products may interact with butorphanol: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receive butorphanol. Do not start these medications while receiving butorphanol without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems or have or ever had a blockage or narrowing of your stomach or intestine, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to receive butorphanol.
• tell your doctor if you have or have ever had a brain tumor, or any condition that increases the amount of pressure in your brain; seizures; or pancreas, gallbladder, thyroid, heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using butorphanol, call your doctor.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using butorphanol.
• you should know that butorphanol injection may make you drowsy and dizzy. Do not drive a car or operate machinery for at least one hour after you receive a dose. After one hour has passed, do not drive until you are certain that you are not dizzy, drowsy, or less alert than usual.
• you should know to not drink alcoholic beverages while you are receiving butorphanol. Alcohol can make the side effects from butorphanol worse.
• you should know that butorphanol may cause drowsiness, dizziness, or fainting, especially during the first hour after you receive the medication. Be sure that you have a comfortable place available in case you need to lie down after you use the medication.
• you should know that butorphanol may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are receiving butorphanol.

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

Butorphanol injection is usually used as needed. If your doctor has told you to use butorphanol injection 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.

Butorphanol injection may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS are severe or do not go away:

• nausea, vomiting
• decreased sexual desire, inability to get or keep an erection

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:

• slow or irregular breathing
• seizures
• 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
• rash, hives, difficulty breathing, or swallowing; or swelling of the face, mouth, tongue or throat
• chest pain, changes in heartbeat
• extreme drowsiness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• unusual snoring or long pauses during breaths during sleep

Butorphanol injection may cause other side effects. Call your doctor if you have any unusual problems while 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If you are using butorphanol injection at home, keep the medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Dispose of any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Store butorphanol injection in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

Symptoms of overdose may include the following:

• slow or shallow breathing, difficulty breathing
• difficulty breathing
• excessive sleepiness, unable to respond or wake up
• narrowing or widening of the pupils (dark circle in the eye)
• cold, clammy skin
• slowed heartbeat

Keep all appointments with your doctor.

Before having any laboratory test , tell your doctor and the laboratory personnel that you are receiving butorphanol.

Do not let anyone use your medication. If you continue to have pain after you finish the butorphanol injection, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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