remifentanil (Intravenous route)

rem-i-FEN-ta-nil

Commonly used brand name(s):

In the U.S.

• Ultiva

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For remifentanil

Remifentanil is used to relieve pain during and after surgery or other medical procedures. It is also used with other medicines (e.g., isoflurane, propofol, midazolam, thiopental, Diprivan®) 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.

Remifentanil is to be administered only by or under the immediate supervision of your doctor.

remifentanil is available only with your doctor's prescription.

Before Using remifentanil

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 remifentanil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to remifentanil 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 in children when given with an anesthetic before or during an operation. However, safety and efficacy have not been established in children for the relief of pain after surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of remifentanil in the elderly. However, elderly patients are more sensitive to the effects of remifentanil, which may require an adjustment in the dose for patients receiving remifentanil.

Pregnancy

Breast Feeding

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.

Interactions with Medicines

Using remifentanil 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.

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Diazepam
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Flurazepam
• Fospropofol
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Nordazepam
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Prazepam
• Propoxyphene
• Quazepam
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Triazolam

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Bradycardia (slow heartbeat) or
• Breathing or lung problems (e.g., apnea, respiratory depression) or
• Heart rhythm problems or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Fentanyl allergy (e.g., Actiq®, Duragesic®, Sublimaze®), history of—Should not be used in patients with this condition.

Proper Use of remifentanil

A nurse or other trained health professional will give you remifentanil in a hospital. remifentanil is given through a needle placed in one of your veins.

Precautions While Using remifentanil

It is very important that your doctor check your progress closely while you are receiving remifentanil to see if it is working properly and to allow for a change in the dose.

remifentanil will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or other anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are receiving remifentanil.

Check with your doctor right away if you have bluish lips or skin; chest pain; difficulty with breathing; a fast, pounding, or irregular heartbeat or pulse; shortness of breath; or muscle stiffness after receiving remifentanil.

Dizziness, lightheadedness, or fainting may occur with remifentanil, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

remifentanil may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.

remifentanil 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:

• Blurred vision
• chest pain or discomfort
• confusion
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• muscle stiffness or tightness
• pale or blue lips, fingernails, or skin
• shortness of breath
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

• Bluish lips or skin
• chills
• decrease in cardiac output
• fast, pounding, or irregular 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

• Abdominal or stomach pain
• 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
• congestion
• 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, sometimes with wheezing
• 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
• increased blood pressure
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased sweating
• increased thirst
• increased urination
• itching
• 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
• runny nose
• seizures
• shakiness in the legs, arms, hands, or feet
• skin rash
• small clicking, bubbling, or rattling sounds in the lungs when listening with a stethoscope
• stuffy nose
• swelling in the legs and ankles
• swelling of the face, fingers, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• voice changes
• vomiting
• weakness and heaviness of the legs
• weight gain

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:

• Anxiety
• blurred or loss of vision
• 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

• Burning while urinating
• heartburn
• hives or welts
• loss of bladder control
• loss of memory
• nightmares
• 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.

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