Nalbuphine Injection

IMPORTANT WARNING:

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.

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 and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use nalbuphine injection with other 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 medicine prescribed?

Nalbuphine injection is used is used to relieve severe pain in people who are expected to need an opioid pain medication and who cannot be treated with other pain medications. 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with nalbuphine injection.

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.

What SPECIAL PRECAUTIONS should I follow?

Before receiving nalbuphine injection,

• 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 or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, a blockage in your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to receive nalbuphine injection.

• tell your doctor if you have or have ever had a recent heart attack; low blood pressure; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); diabetes; seizures; urinary problems; gallbladder problems; or liver, pancreas, or kidney disease.

• 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.

• tell your doctor if you are breastfeeding. Nalbuphine can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, difficulty breathing, or limpness in breastfed infants.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using nalbuphine injection.

• 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.

• 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.

• you should know that nalbuphine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that nalbuphine may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using nalbuphine injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Nalbuphine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• drowsiness
• dizziness
• dry mouth
• headache

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
• slowed 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
• rash; hives; itching; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat

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).

What should I do in case of 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. Ask your doctor about other ways that you can obtain naloxone (directly from a pharmacy or as part of a community based program). 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
• excessive sleepiness
• unable to respond or wake up
• cold, clammy skin
• limp muscles
• narrowed or widened pupils (dark circles in the middle of the eyes)
• slow heartbeat
• 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 injection.

This prescription is not refillable. If you continue to have pain after you finish nalbuphine injection, call your doctor.

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.