IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
BUTORPHANOL TARTRATE - NASAL
COMMON BRAND NAME(S): Stadol NS
USES: This medication is used to treat moderate to severe pain, including pain from surgery, muscle pain, and migraine headaches. Butorphanol is a narcotic pain reliever similar to morphine. It acts on certain centers in the brain to give you pain relief. Butorphanol can also block the effects of narcotics and can cause withdrawal symptoms in people dependent on narcotics. If possible, people who have recently used narcotics in high doses or for a long time should not use butorphanol. (See also Side Effects section.)
HOW TO USE: Read the Medication Guide and 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 1 spray in 1 nostril or as directed by your doctor. If you still have pain after 60-90 minutes, your doctor may direct you to use a second spray in the other nostril. If needed, butorphanol may be used again in 3-4 hours after the second spray or as directed by your doctor. Some people will need 2 sprays (1 in each nostril) at the same time. In this case, they should remain lying down because there is a higher risk of drowsiness and dizziness with this higher dose. Follow your doctor's directions carefully. The dosage is based on your medical condition and response to therapy. 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. 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. If you use a nasal decongestant spray (e.g., oxymetazoline), the decongestant may make this pain medication work more slowly. Ask your doctor or pharmacist about using these 2 medications. If nausea occurs, consult your doctor or pharmacist for ways to decrease it (e.g., antihistamines, lying down with as little head movement as possible). This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, use it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. 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. Inform your doctor if your pain persists or worsens.
SIDE EFFECTS: 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 persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help with selecting a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she 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. Butorphanol can cause withdrawal reactions in people who are physically dependent on narcotics. The seriousness of the withdrawal symptoms depends on the level of dependence and the dose of butorphanol. Tell your doctor immediately if you develop symptoms such as anxiety, agitation, trouble sleeping, sweating, stomach cramps, and diarrhea. Tell your doctor immediately if any of these unlikely but serious side effects occur: bleeding from the nose, mental/mood changes (e.g., anxiety, confusion, hallucinations). Tell your doctor immediately if any of these rare but very serious side effects occur: difficult/slow/shallow breathing, fast/slow/irregular heartbeat, seizures, severe stomach/abdominal pain, change in the amount of urine. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: physical dependence on narcotics, severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), severe breathing problems (e.g., respiratory depression, hypercapnia, hypoxia), certain bowel diseases (e.g., paralytic ileus), intoxication with alcohol or medications that depress the nervous system or your breathing (CNS/respiratory depressants such as tranquilizers/sedatives). Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis), adrenal gland problems (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, chest pain, recent heart attack), high blood pressure, kidney disease, liver disease, lung diseases (e.g., asthma, chronic obstructive pulmonary disease-COPD), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), personal or family history of regular use/abuse of drugs/alcohol, difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to the effects of this drug, especially dizziness. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), narcotic blockers (e.g., naltrexone), nasal decongestants (e.g., oxymetazoline). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, deep sleep.
NOTES: Do not share this medication with others. 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.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.
Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.