Sufentanil (Injection)

Sufentanil (Injection) is used to ease pain during and after surgery or other medical procedures (for example, childbirth). It is also used alongside other medicines just before or during an operation to enhance the effect of the anesthetic.

Sufentanil is part of a group of medicines called narcotic analgesics (pain medicines). It works by affecting the central nervous system (CNS) or brain to relieve pain.

This medicine should only be given by or under the direct supervision of your doctor.

Your doctor will monitor your progress closely while you or your child are using this medicine. This helps your doctor see if the medicine is effective and to determine if you should keep using it.

Signs of an overdose include: severe dizziness or weakness, slow heartbeat or breathing, seizures, difficulty breathing, and cold, clammy skin. Contact your doctor immediately if you or your child experience these symptoms.

This medicine may lead to sleep-related breathing issues (like sleep apnea or sleep-related low oxygen levels). Your doctor may lower your dose if you or your child have sleep apnea (pauses in breathing during sleep) while taking this medicine.

Talk to your doctor before using this medicine with alcohol or other medications that impact the central nervous system (CNS). Using alcohol or other CNS-affecting medications with sufentanil may increase side effects, such as dizziness, difficulty concentrating, drowsiness, unusual dreams, and trouble sleeping. Some examples of CNS-affecting medications include antihistamines or allergy/cold medicines, sedatives, tranquilizers, or sleeping aids, medications for depression, anxiety, prescription pain medications or narcotics, attention deficit and hyperactivity disorder medications, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may cause dizziness, drowsiness, or lightheadedness. Do not drive or engage in activities that could be dangerous until you know how this medicine affects you. If you feel dizzy, sit or lie down. Stand up slowly.

Inform your doctor if you or your child experience muscle stiffness in the neck, chest, hands, or legs after taking this medicine.

Contact your doctor immediately if you or your child have anxiety, restlessness, a rapid heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or experience hallucinations. These may indicate a serious condition called serotonin syndrome. Your risk may increase if you are also taking other medications that affect serotonin levels.

This medicine may be habit-forming. If you feel the medicine is not as effective, do not exceed your prescribed dose. Contact your doctor for guidance.

Long-term use of narcotics can lead to severe constipation. To help prevent this, your doctor may advise you to take laxatives, drink plenty of fluids, or increase your dietary fiber. Follow these instructions carefully, as ongoing constipation can result in more serious issues.

Using this medicine during pregnancy may lead to neonatal withdrawal syndrome in your newborn. Notify your doctor immediately if your baby has an unusual sleep pattern, diarrhea, a high-pitched cry, irritability, shaking or tremors, weight loss, vomiting, or does not gain weight.

Using too much of this medicine may cause infertility (being unable to have children). Speak with your doctor before using this medicine if you plan to have children.

Do not consume grapefruit or drink grapefruit juice while taking this medicine.

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

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other drugs. As well inform 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sufentanil injection in children.

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially essential 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 medication with any of the following medicines is not recommended. Your clinician may decide not to treat you with this drug or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this drug with any of the following medicines is normally not recommended, but may be required in some cases. If both medications are prescribed together, your doctor may change the dose or how often you use one or both of the drugs.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Piritramide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medications 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 as well 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 physician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Alcohol abuse, or history of or
• Brain tumor or
• Breathing or lung problems (eg, COPD, cor pulmonale, hypercapnia, sleep apnea) or
• Drug dependence, especially with narcotics, or history of or
• Head injury, history of or
• Weakened physical condition—May increase risk for more severe adverse effects.

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

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

Along with its needed effects, Sufentanil (Injection) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Incidence not known

• Agitation
• blurred vision
• confusion
• cough
• darkening of the skin
• diarrhea
• difficult or troubled breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• fever
• hives, itching, or skin rash
• irregular, fast or slow, or shallow breathing
• loss of appetite
• mental depression
• muscle stiffness
• nausea
• overactive reflexes
• pale or blue lips, fingernails, or skin
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• shivering
• sweating
• talking or acting with excitement you cannot control
• tightness in the chest
• trembling or shaking
• twitching
• unusual tiredness or weakness
• vomiting

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.

• Sufenta

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed into a vein or into your back (spinal cord).

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