Description
Remifentanil injection is used to relieve pain during and after surgery or other medical procedures. It is also used with other medicines (eg, isoflurane, propofol, midazolam, thiopental) just before or during an operation to help the anesthetic work better.
Remifentanil 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 direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for 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 remifentanil injection when given with an anesthetic before or during an operation in children. Safety and efficacy have been established.
Appropriate studies on the relationship of age to the effects of remifentanil injection for the relief of pain after surgery have not been performed 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 remifentanil injection in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or lung problems, which may require caution and an adjustment in the dose for patients receiving remifentanil.
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
- Alfentanil
- Almotriptan
- Alprazolam
- Amifampridine
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Anileridine
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Baclofen
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Bromazepam
- Bromopride
- Brompheniramine
- Buprenorphine
- Bupropion
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
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
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 problems (eg, increased pressure, tumors) or
- Breathing or lung problems (eg, apnea, COPD, cor pulmonale, respiratory depression) or
- Drug dependence, especially with narcotics, or history of or
- Head injury, history of—Use with caution. May increase risk for more serious side effects.
- Diabetes or
- 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.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
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. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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 remifentanil 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.
Tell your doctor if you or your child have stiffness in the muscles of your neck, chest, hands, or legs after receiving this medicine.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
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.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
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.
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:
More common
- Blurred vision
- chest pain or discomfort
- confusion
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness, or fainting
- muscle stiffness or tightness
- pale or blue lips, fingernails, or skin
- slow or irregular heartbeat
- sweating
- unusual tiredness or weakness
Less common
- Bluish lips or skin
- chills
- decrease in cardiac output
- fast, pounding, or heartbeat or pulse
- feeling of warmth
- fever
- headache
- nausea or vomiting
- nervousness
- not breathing
- pain after surgery
- pain in the shoulders, arms, jaw, or neck
- pounding in the ears
- problems with bleeding or clotting
- redness of the face, neck, arms, and occasionally, upper chest
- shivering
Rare
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- cough or hoarseness
- cough producing mucus
- coughing that sometimes produces a pink frothy sputum
- coughing up blood
- decreased frequency or amount of urine
- difficult, fast, or noisy breathing
- difficulty with swallowing
- disorientation
- dry mouth
- dryness or soreness of the throat
- dysphoria
- eye pain
- flushed, dry skin
- fruit-like breath odor
- general feeling of illness
- hiccups
- hives, itching, or skin rash
- increased blood pressure
- increased hunger
- increased menstrual flow or vaginal bleeding
- increased sweating
- increased thirst
- increased urination
- loss of appetite
- lower back or side pain
- muscle cramps or pain
- nervousness
- noisy breathing
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid heartbeat
- red or black, tarry stools
- red or dark brown urine
- seizures
- shakiness in the legs, arms, hands, or feet
- small clicking, bubbling, or rattling sounds in the lungs when listening with a stethoscope
- stomach pain
- stuffy or runny nose
- swelling in the legs and ankles
- swelling of the face, fingers, or lower legs
- tender, swollen glands in the neck
- unexplained weight loss
- unusual bleeding or bruising
- voice changes
- vomiting
- weakness and heaviness of the legs
- weight gain
Incidence not known
- Anxiety
- cold sweats
- coma
- cool, pale skin
- depression
- increased sensitivity to pain
- nightmares
- shakiness
- slurred speech
- worsening of pain
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 the medicine. 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:
Less common
- Difficulty having a bowel movement (stool)
- disturbed color perception
- double vision
- halos around lights
- hyperventilation
- night blindness
- overbright appearance of lights
- pain at the injection site
- restlessness
- trouble with sleeping
- tunnel vision
Rare
- Burning while urinating
- heartburn
- hives or welts
- loss of bladder control
- loss of memory
- problems with memory
- seeing, hearing, or feeling things that are not there
- severe constipation
- severe vomiting
- trouble with urinating
- uncontrolled eye movements
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-20073019
