FDA Drug Safety Communication:
- As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
Nalbuphine injection may be habit-forming. Do not use more of it, use it more often, 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, has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse nalbuphine injection if you have or have ever had any of these conditions.
Nalbuphine 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. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use nalbuphine injection. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. 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.
Tell your doctor if you are pregnant or plan to become pregnant. If you use nalbuphine injection regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
Nalbuphine injection may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); medications for mental illness or nausea, other medications for pain; muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use nalbuphine injection with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Drinking alcohol or using street drugs during your treatment with nalbuphine also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take any prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.
Talk to your doctor about the risk(s) of using nalbuphine injection.
Why is this medication prescribed?
Nalbuphine injection is used is used to relieve moderate to severe pain. It is also used with other medications and anesthesic agents before, during, and after surgery and other medical procedures. Nalbuphine injection 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?
Nalbuphine injection comes as a solution (liquid) to inject subcutaneously (under the skin), intravenously (into a vein), or intramuscularly (into a muscle). Nalbuphine injection is administered by a doctor or nurse. It is usually injected once every 3 to 6 hours as needed.
Your doctor may adjust your dose of nalbuphine injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with nalbuphine injection.
You may receive nalbuphine injection in a hospital, or you may use the medication at home. If you will be using nalbuphine injection at home, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or other healthcare provider to explain any part you do not understand. Use nalbuphine injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
If you have used nalbuphine injection for longer than a few days, do not stop using it suddenly. If you suddenly stop using nalbuphine injection, you may experience withdrawal symptoms including restlessness; teary eyes; runny nose; yawning; sweating; chills; muscle, back or joint pain; widening of the pupils; irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; loss of appetite; vomiting; diarrhea; fast breathing; or fast heartbeat. Your doctor will probably decrease your dose gradually.
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 receiving nalbuphine,
- tell your doctor and pharmacist if you are allergic to nalbuphine, any other medications, or any of the ingredients in nalbuphine injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig, Zomig-ZMT); mirtazapine (Remeron); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso, Sustol), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi, in Akynzeo); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), and milnacipran (Savella), venlafaxine (Effexor); tramadol; trazodone; and tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor, Zonalon), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with nalbuphine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. 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 have or have ever had a recent heart attack, or liver, or kidney disease.
- tell your doctor if you are breastfeeding.
- if you are having surgery, including dental surgery or biliary tract surgery, tell the doctor or dentist that you are using nalbuphine.
- you should know that nalbuphine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using nalbuphine.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Nalbuphine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dry mouth
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- extreme tiredness
- nausea, vomiting, loss of appetite, weakness, or dizziness
- changes in heartbeat
- 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
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
Nalbuphine 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
In case of emergency/overdose
While using nalbuphine injection, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
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, shallow, or irregular breathing
- unable to respond or wake up
- cold, clammy skin
- small pupils
- slow heartbeat
- blurred vision
- dilated pupils
- unusual snoring
What other information should I know?
Keep all appointments with your doctor.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using nalbuphine.
This prescription is not refillable. If you are using nalbuphine to control your pain on a long term basis, be sure to schedule appointments with your doctor so that you do not run out of medication. If you are using nalbuphine on a short-term basis, call your doctor if you continue to experience pain after you finish the medication.
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.
¶ This branded product is no longer on the market. Generic alternatives may be available.