Nasal route (Spray)_x000D_ _x000D_ Butorphanol tartrate has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental exposure to butorphanol, especially in children, can result in fatal overdose of butorphanol. Prolonged use of butorphanol tartrate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. The concomitant use of butorphanol tartrate with all CYP3A4 inhibitors may result in an increase in butorphanol plasma concentrations, which may cause potentially fatal respiratory depression, and discontinuation of a concomitantly used CYP3A4 inducer may result in an increase in butorphanol plasma concentrations; monitor patients receiving butorphanol tartrate and any CYP3A4 inhibitor or inducer. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation ._x000D_
Overview TOP
_x000D_ Butorphanol nasal spray is used to relieve pain that is not relieved by other pain medicines. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain._x000D_ _x000D_ When butorphanol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely._x000D_ _x000D_ This medicine is available only with your doctor’s prescription._x000D_
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Proper Use TOP
_x000D_ This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions._x000D_ _x000D_ This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away._x000D_ _x000D_ To use the nasal spray:_x000D_
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- Blow your nose gently to clear the nostrils.
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- Take the cap off of the bottle and remove the clip from the neck of the pump.
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- If you are using the medicine for the first time, you will need to prime the spray pump.
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- To do this, hold the spray bottle with your thumb on the bottom of the bottle and your index and middle fingers on the 2 flaps on the side of the pump.
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- Push down with your index and middle fingers. Keep pumping until you see the medicine spray from the bottle.
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- Put the tip of the spray pump into your nostril.
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- Close the other nostril with your finger and lean your head slightly forward.
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- Sniff gently and push down on the 2 flaps to spray the medicine into your nose. Keep your mouth closed as you are breathing in.
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- Take the spray pump out of your nostril and tilt your head back. Sniff a few more times.
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_x000D_ After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on._x000D_ _x000D_
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Dosing TOP
_x000D_ The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so._x000D_ _x000D_ The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine._x000D_
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- For nasal dosage form (spray):_x000D_
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- Adults—1 milligram (mg) or 1 spray in one nostril. A second spray may be taken 60 to 90 minutes after the first dose if needed. This may be repeated every 3 to 4 hours as needed.
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- Children—Use and dose must be determined by your doctor.
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