Description
Sufentanil injection is used to relieve pain during and after surgery or other medical procedures (eg, childbirth). It is also used with other medicines just before or during an operation to help the anesthetic work better.
Sufentanil belongs to the group of medicines known as narcotic analgesics (pain medicines). It works by acting on the central nervous system (CNS) or brain to relieve pain.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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 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 problems 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.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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 medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
- Naltrexone
- Safinamide
- Samidorphan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Desflurane
Other Interactions
Certain medicines 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 medicine 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 often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 serious side effects.
- Gallbladder problems 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 because of slower removal of the medicine from the body.
Proper Use
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).
Precautions
Your doctor will check your progress closely while you or your child 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 receive it.
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 or your child notice these symptoms.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you or your child have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with sufentanil may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
Tell your doctor if you or your child have stiffness in the muscles of your neck, chest, hands, or legs after receiving this medicine.
Check with your doctor right away if you or your child 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.
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. Call your doctor for instructions.
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.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. 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.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately 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.
DRG-20406181
