Nubain (Injection)

Nalbuphine injection is used to relieve moderate to severe pain. It may also be given before and after surgery or with general anesthesia before an operation. It can also help relieve pain during childbirth.

Nalbuphine is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

Using a nalbuphine injection for a long time may lead to habit-forming behaviors, causing mental or physical dependence. However, people with ongoing pain should not avoid using narcotics due to fear of dependence. Mental dependence (addiction) is not likely to happen when narcotics are used for pain relief. Physical dependence can result in withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress while you are receiving this medicine. This will help your doctor see if the medicine is working well and decide if you should continue using it.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that can make you sleepy or less alert). Some examples of CNS depressants include antihistamines or allergy and cold medicines, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these other medicines while you are using this medicine.

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

This medicine may cause sleep-related breathing problems (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea (pausing breathing for short periods during sleep) while using this medicine.

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

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

This medicine may make you feel dizzy, drowsy, or lightheaded. Make sure you understand how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may recommend taking laxatives, drinking plenty of fluids, or increasing your fiber intake. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious issues.

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

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

Contact your doctor immediately if you experience anxiety, restlessness, a rapid 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 are also taking certain other medicines that affect serotonin levels in your body.

Using this medicine during pregnancy may cause neonatal withdrawal syndrome in your newborn. Inform your doctor right away if your baby has unusual sleep patterns, diarrhea, a high-pitched cry, irritability, shaking or tremors, weight loss, vomiting, or fails to gain weight.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the drug must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other medications. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nalbuphine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Nubain® in the elderly. Nevertheless, elderly patients are more likely to have kidney, liver, heart, or lung issues, which may require caution and an adjustment in the dose for patients receiving this medicine.

No guidance is available on the relationship of age to the effects of nalbuphine injection in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this drug, it is especially critical that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medicines is not advised. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following medicines is typically not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medications.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amitriptyline
• Amobarbital
• Amoxapine
• Amphetamine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cocaine
• Codeine
• Daridorexant
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fospropofol
• Frovatriptan
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Imipramine
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lorazepam
• Lorcaserin
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Naratriptan
• Nefazodone
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical problems, especially:

• Adrenal issues or
• Alcohol abuse, history of or
• Brain tumor or
• Breathing or lung problems (eg, COPD, hypercapnia, sleep apnea) or
• Cor pulmonale (heart condition) or
• Depression, or history of or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Head injury, history of or
• Mental health problem, or history of or
• Weakened physical condition—Use with caution. May raise chance for more serious side effects.

• Bradycardia (slow heartbeat) or
• Gallbladder problems or
• Heart attack or
• Hypotension (low blood pressure) or
• Pancreatitis (inflammation of the pancreas) or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Breathing or lung issues (eg, asthma, respiratory depression), serious or
• Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medication from the body.

Along with its needed effects, Nubain (Injection) may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Chest pain or discomfort
• difficult or labored breathing
• difficulty with swallowing
• fainting
• false beliefs that cannot be changed by facts
• fast, pounding, or irregular heartbeat or pulse
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• sense of detachment from self or body
• slow or irregular heartbeat

Incidence not known

• Blue lips and fingernails
• convulsions
• coughing that sometimes produces a pink frothy sputum
• decrease in consciousness
• difficult, fast, or noisy breathing, sometimes with wheezing
• fear or nervousness
• fever
• hyperventilation
• increased sweating
• loss of bladder control
• muscle spasm or jerking of all extremities
• pale skin
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• stomach pain
• sudden loss of consciousness
• swelling in the legs and ankles
• trembling or shaking of the hands or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Nubain (Injection). Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness or lightheadedness
• drowsiness
• feeling of constant movement of self or surroundings
• nausea
• relaxed and calm
• sensation of spinning
• sleepiness
• sweaty, clammy skin
• vomiting

Less common

• Dry mouth
• Headache

Rare

• Acid or sour stomach
• aggressive or angry
• belching
• blurred vision
• burning
• changes in speech
• confusion
• cough
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dysphoria
• excessive crying
• false or unusual sense of well-being
• feeling of heaviness
• feeling of warmth
• feeling sad or empty
• floating feeling
• frequent strong or increased urge to urinate
• headache
• heartburn
• hives or welts, itching skin, rash
• indigestion
• irritability
• lack of appetite
• loss of interest or pleasure
• numbness
• pounding in the ears
• restlessness
• slow or fast heartbeat
• stomach discomfort or upset
• tiredness
• trouble concentrating
• trouble sleeping
• tingling feeling of unreality
• unusual tiredness or weakness

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Nubain

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin or into a muscle or a vein.