Nubain

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.

Side effects of Nalbuphine are sedation, dizziness, nausea, vomiting, dry mouth, headache, and low heart rate. Like other narcotics nalbuphine can cause respiratory depression (decreased rate or depth of breathing).

It may produce withdrawal in opioid dependent patients. Nalbuphine is a controlled substance and is habit forming. Mental and physical dependence can occur. Abruptly stopping the drug in patients who have been taking the drug for a long time can precipitate a withdrawal reaction. Symptoms of withdrawal include nausea, diarrhea, coughing, tearing, nasal discharge, profuse sweating, twitching muscles, and yawning.

Nalbuphine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Drinking alcohol can increase certain side effects of nalbuphine.

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Tell your doctor if you have recently taken a sleeping pill, other narcotic pain medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Using nalbuphine may cause unpleasant side effects if you are already using other similar medicines. Using narcotic medications together can also increase the side effects of these medications.

Other drugs may interact with nalbuphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with nalbuphine.

Nalbuphine Hydrochloride Injection is supplied as follows:

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light. Store in carton until contents have been used.

Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Sep 2016

You should not use this medication if you are allergic to nalbuphine.

Before you receive nalbuphine, tell your doctor if you have asthma or other breathing problems, liver or kidney disease, a slow heart rate, severe infection, gallbladder disease, mental illness, a history of head injury or brain tumor, or if you have recently had a heart attack.

Nalbuphine may be habit forming. Tell your doctor if you have a history of drug abuse or addiction.

Using nalbuphine may cause unpleasant side effects if you are already using other similar medicines. Using narcotic medications together can also increase the side effects of these medications.

Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

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 a similar opioid medicine and are tolerant to it. Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

To make sure nalbuphine is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• problems with your pancreas or adrenal gland;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• liver or kidney disease;

• a slow heart rate, or if you have recently had a heart attack;

• if you use an MAO inhibitor such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with nalbuphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Nalbuphine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Although nalbuphine is sometimes used during labor and delivery, this medicine can cause breathing problems or life-threatening withdrawal symptoms in the newborn. If you receive nalbuphine during labor and delivery, your caregivers will watch your baby closely for any serious side effects of nalbuphine. These effects can usually be treated quickly in a hospital setting.

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

Nalbuphine can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.

In the U.S.

• Nubain

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want to gradually reduce the amount of medicine given to you before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be receiving. (See Interaction with Other Central Nervous System Depressants under WARNINGS). In non-tolerant individuals, the recommended single maximum dose is 20 mg, with a maximum total daily dose of 160 mg. The use of Nubain as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of Nubain range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minute period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of Nubain may be followed by respiratory depression which can be reversed with the opioid antagonist NARCAN® (naloxone hydrochloride).

Nubain is physically incompatible with nafcillin and keterolac.

Patients Dependent on Opioids

Patients who have been taking opioids chronically may experience withdrawal symptoms upon the administration of Nubain. If unduly troublesome, opioid withdrawal symptoms can be controlled by the slow intravenous administration of small increments of morphine, until relief occurs. If the previous analgesic was morphine, meperidine, codeine, or other opioid with similar duration of activity, one-fourth of the anticipated dose of Nubain can be administered initially and the patient observed for signs of withdrawal, i.e., abdominal cramps, nausea and vomiting, lacrimation, rhinorrhea, anxiety, restlessness, elevation of temperature or piloerection. If untoward symptoms do not occur, progressively larger doses may be tried at appropriate intervals until the desired level of analgesia is obtained with Nubain.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Nubain® (nalbuphine hydrochloride) injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in:

NDC 63481-508-05       (sulfite-free) 10 mg/mL, 10 mL multiple dose vials (box of 1)
NDC 63481-432-10       (sulfite/paraben-free) 10 mg/mL, 1 mL ampuls (box of 10)
NDC 63481-509-05       (sulfite-free) 20 mg/mL, 10 mL multiple dose vials (box of 1)
NDC 63481-433-10       (sulfite/paraben-free) 20 mg/mL, 1 mL ampuls (box of 10)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317

Manufactured by:
Bristol-Myers Squibb Holdings Pharma, Ltd.
Manati, Puerto Rico 00674 USA

Nubain® is a Registered Trademark of Endo Pharmaceuticals Inc.
NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc.
 

                                         Copyright © Endo Pharmaceuticals Inc. 2005

Printed in U.S.A.                                                                                             51-022542-01/August, 2005