AUDIENCE: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology
ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief (see List of Opioid Medicines in the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm). However, opioids also carry serious risks, including of misuse and abuse, addiction, overdose, and death.
Prescription opioids are divided into two main categories – immediate-release (IR) products, usually intended for use every 4 to 6 hours; and extended release/long acting (ER/LA) products, intended to be taken once or twice a day, depending on the individual product and patient.
See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for additional information, including a listing of opioids, serotonergic medicines, and a data summary.
Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.
Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.
Decreased sex hormone levels:
Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Butorphanol nasal spray is used to relieve moderate to severe pain. Butorphanol is in a class of medications called opioid agonist-antagonists. It works by changing the way the body senses pain.
How should this medicine be used?
Butorphanol nasal spray comes as a solution (liquid) to spray in the nose. It is usually used as needed for pain, but not more often than once every 3 to 4 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Butorphanol nasal spray should relieve your pain soon after you use it. If you are using a low starting dose of butorphanol nasal spray, your doctor may tell you that you may use a second dose if you still have pain 60 to 90 minutes after your first dose. Do not use this second dose unless your doctor tells you that you may. Call your doctor if you still have pain after using butorphanol nasal spray as prescribed. Also call your doctor if you have used butorphanol nasal spray for some time and find that it no longer works as well as it did at the beginning of your treatment.
Butorphanol nasal spray may be habit-forming. Use butorphanol nasal spray exactly as directed. Do not use a larger dose or use it more often or for a longer time than prescribed by your doctor. Call your doctor if you develop a strong desire to use more medication than prescribed.
Do not stop using butorphanol nasal spray without talking to your doctor. If you suddenly stop using butorphanol nasal spray, you may experience withdrawal symptoms such as nervousness, agitation, shakiness, diarrhea, chills, sweats, difficulty falling asleep or staying asleep, loss of coordination,confusion, or hallucinations (seeing things or hearing voices that do not exist).Your doctor will probably decrease your dose gradually.
Before you use butorphanol nasal spray for the first time, read the written directions provided by the manufacturer. Ask your doctor or pharmacist if you have any questions about how to use butorphanol nasal spray.
To use butorphanol nasal spray, follow these directions:
- Wash your hands.
- Gently blow your nose.
- Remove the clear cover and protective clip from the bottle.
- If you are using a new pump or a pump that has not been used in 48 hours or longer, you must prime the pump before use. Hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom. Be sure that the bottle is aimed away from you, other people, and animals. Pump the bottle firmly and quickly (up to 8 strokes) until a fine spray appears.
- Insert the tip of the sprayer approximately 1/4 inch (0.6 cm) into one nostril, pointing the tip toward the back of your nose.
- Close your other nostril with your finger and tilt your head slightly forward.
- Pump the spray firmly and quickly one time and sniff gently with your mouth closed.
- Remove the sprayer from your nose. Tilt your head backward and sniff gently for a few seconds.
- Replace the protective clip and cover on the spray bottle. Put the bottle back in the child-resistant storage container.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with butorphanol nasal spray and each time you refill 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/cder) to obtain the Medication Guide.
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 butorphanol nasal spray,
- tell your doctor and pharmacist if you are allergic to butorphanol, any other medications, or benzethonium chloride (a preservative found in some medications and personal care products).
- 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 amobarbital (Amytal, in Tuinal), butabarbital (Butisol), pentobarbital, phenobarbital, or secobarbital (Seconal); erythromycin (E.E.S., E-Mycin, Erythrocin); medications for anxiety, mental illness, or seizures; monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); nasal sprays such as oxymetazoline (Afrin, Dristan, others); sedatives; sleeping pills; sumatriptan (Imitrex); theophylline (Theochron, Theolair); and tranquilizers. Also tell your doctor or pharmacist if you are taking narcotic medications for pain or if you have recently taken these medications.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you use or have ever used street drugs or have overused prescription medications or if you need to take narcotic pain medications regularly in order to feel well. Also tell your doctor if you have or have ever had a head injury; any condition that increases the pressure in your brain or skull; problems with your brain or nervous system; a heart attack;breathing problems; high blood pressure; or 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 nasal spray, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using butorphanol nasal spray.
- you should know that butorphanol nasal spray may cause drowsiness, dizziness, or fainting, especially during the first hour after you use the medication.Be sure that you have a comfortable place available in case you need to lie down after you use the medication. Do not drive a car or operate machinery for at least one hour after using butorphanol nasal spray.After one hour has passed, do not drive until you are sure that you are not dizzy, drowsy, or less alert than usual.
- do not drink alcohol while using butorphanol nasal spray. Alcohol can make the side effects of the medication worse.
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?
Butorphanol nasal spray is usually used as needed. If your doctor has told you to use butorphanol nasal spray 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.
What side effects can this medication cause?
Butorphanol nasal spray 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
- stomach pain
- loss of appetite
- feeling hot
- pain, burning, numbness, or tingling in the hands or feet
- uncontrollable shaking of a part of the body
- intense happiness
- feeling of floating
- feeling of sadness, unpleasantness, or discomfort
- blurred vision
- ringing in the ears
- ear pain
- unpleasant taste
- dry mouth
- difficulty urinating
- stuffy or irritated nose
- sore throat
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- slowed breathing
- difficulty breathing
- irregular or pounding heartbeat
- hallucinations (seeing things or hearing voices that do not exist)
Butorphanol nasal spray may cause other side effects. Call your doctor if you have any unusual problems while you are 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Store butorphanol nasal spray in its child-resistant container, tightly closed and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of butorphanol nasal spray as soon as it becomes outdated or is no longer needed.
Store butorphanol nasal spray in a safe place where no one can use it accidentally or on purpose.
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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slow or shallow breathing
- coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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¶ This branded product is no longer on the market. Generic alternatives may be available.