Butorphanol Tartrate

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using butorphanol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is a nasal spray. Have your doctor or pharmacist show the proper way to use the nasal spray. For best results, blow your nose gently before using. Follow the patient instruction leaflet for priming the pump before first use. If the spray has not been used in 48 hours, you may need to prime the pump again before use. Use this product as directed by your doctor, usually every 3 to 4 hours as needed. This drug can cause a drop in blood pressure, especially within the first hour after use. This can cause dizziness, lightheadedness, and fainting. To lower this risk, remain sitting or lying down after using this medication. Follow your doctor's directions carefully. The dosage is based on your medical condition and response to treatment. Do not increase the dose or use it more often than directed by your doctor. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. If you use a nasal decongestant spray (such as oxymetazoline), the decongestant may make this pain medication work more slowly. Ask your doctor or pharmacist about using these 2 medications. If you have nausea, ask your doctor or pharmacist about ways to decrease it (such as lying down for 1 to 2 hours with as little head movement as possible). Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Tell your doctor if your pain does not get better or if it gets worse.

See also Warning section. Drowsiness, dizziness, blurred vision, flushing, headache, nausea, vomiting, constipation, nasal irritation/congestion, trouble sleeping, dry mouth, and sweating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: bleeding from the nose, interrupted breathing during sleep (sleep apnea), mental/mood changes (such as anxiety, confusion, hallucinations), fast/slow/irregular heartbeat, severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss). Get medical help right away if you have any very serious side effects, including: difficult/slow/shallow breathing, severe drowsiness/difficulty waking up, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using butorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzethonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (such as gallbladder disease, pancreatitis), adrenal gland problems (such as Addison's disease), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), heart problems (such as irregular heartbeat, chest pain, recent heart attack), high blood pressure, kidney disease, liver disease, breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), mental/mood disorders (such as toxic psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (such as diarrhea due to infection, paralytic ileus), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), difficulty urinating (such as due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.) This drug passes into breast milk. Consult your doctor before breast-feeding.

See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), naltrexone, nasal decongestants (such as oxymetazoline), samidorphan. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Other medications can affect the removal of butorphanol from your body, which may affect how butorphanol works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin, rifampin), ritonavir, certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This medication may interfere with certain lab tests (such as amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, coma.

Do not share this medication with others. Sharing it is against the law. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Not applicable.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.