Nalbuphine is an opioid pain medication that is used to treat moderate to severe pain. It is also used for treating pain just after surgery or childbirth.

Nalbuphine may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. `

Fatal side effects can occur if you receive nalbuphine after having recently used alcohol, sedatives, tranquilizers, or other opioid medications.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Nalbuphine is injected under the skin or into a muscle, or as an infusion into a vein. A healthcare provider will give you this injection.

When used to treat pain, nalbuphine is usually given every 3 to 6 hours as needed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you stop using nalbuphine suddenly after long-term use, you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using nalbuphine.

Usual Adult Dose for Pain:

Initial dose: 10 mg IV, IM, or subcutaneous every 3 to 6 hours as needed

OPIOID NON-TOLERANT:
Maximum single dose: 20 mg
Maximum daily dose: 160 mg

Comments:
-Usual adult dose is based on a 70 kg individual; dosage should be adjusted according to the severity of pain, physical status, and concomitant medications.
-Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and with each dose increase.
-Because of the risks of addiction, abuse, and misuse, reserve use to patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia or are not expected to provide adequate analgesia.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Anesthesia:

Supplement to balanced anesthesia:
Induction dose: 0.3 to 3 mg/kg IV over 10 to 15 minutes
Maintenance dose: 0.25 to 0.5 mg/kg in single IV administrations as required

Comments:
-This drug should be administered as a supplement to general anesthesia by persons specifically trained in the use of IV anesthetics and management of the respiratory effects of potent opioids; naloxone, resuscitative and intubation equipment and oxygen should be readily available.

Use: As a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

You should not be treated with nalbuphine if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

Your dose needs may be different if you are already using an opioid medicine and are tolerant to it. Tell your doctor about all other pain medicines you have recently used.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• problems with your gallbladder, pancreas, or adrenal gland;

• a head injury, brain tumor, or seizures;

• alcoholism or drug addiction;

• liver or kidney disease; or

• a slow heart rate, or a heart attack.

Unless you are given nalbuphine during labor or delivery, tell your doctor if you are pregnant before you are treated with this medicine.

Although nalbuphine is sometimes used during childbirth, receiving this medicine during labor may cause side effects in the newborn baby, including slow heartbeats and breathing problems. Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Because you will receive nalbuphine in a clinical setting, you are not likely to miss a dose.

A nalbuphine overdose can be fatal. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Since nalbuphine is given in a medical setting, you will be watched closely to make sure you do not receive too much of nalbuphine. Your caregivers will quickly treat you if you have overdose symptoms.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your caregiver right away if you have:

• shallow breathing, breathing that stops during sleep;

• a light-headed feeling, like you might pass out;

• severe drowsiness;

• severe constipation;

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of nalbuphine may include:

• drowsiness;

• dizziness, spinning sensation;

• dry mouth;

• headache;

• sweating;

• cold, clammy skin; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect nalbuphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.