Description
Dexmedetomidine is used to treat agitation caused by schizophrenia or bipolar I or II disorder (manic-depressive illness).
This medicine is to be given only by or under the direct supervision of your doctor.
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 have not been performed on the relationship of age to the effects of dexmedetomidine 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 dexmedetomidine in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, low blood pressure, slow heartbeat), which may require caution and an adjustment in the dose for patients receiving this medicine.
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.
- Bepridil
- Cisapride
- Dronedarone
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amobarbital
- Anagrelide
- Anileridine
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Baclofen
- Bedaquiline
- Benperidol
- Benzhydrocodone
- Bromazepam
- Bromopride
- Buprenorphine
- Buserelin
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Ceritinib
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
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. 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart disease (eg, heart block, ventricular dysfunction), severe or
- Heart rhythm problems (eg, slow heartbeat, QT prolongation, torsades de pointes) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypotension (low blood pressure) or
- Syncope (fainting), history of—Should not be used in patients with these conditions.
- Diabetes or
- Hypertension (high blood pressure) or
- Hypovolemia (low blood volume)—Use with caution. May make these conditions worse.
- 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 this medicine in a medical facility. This medicine is a film that is given under the tongue (sublingual) or behind the lower lip (buccal).
To use the buccal film:
- Place the film behind lower lip until it is dissolved.
- Do not eat or drink anything for at least 1 hour after taking the medicine.
- Do not chew or swallow it.
To use the sublingual film:
- Place the film under the tongue until it is dissolved.
- Do not eat or drink anything for at least 15 minutes after taking the medicine.
- Do not chew or swallow it.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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.
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
- chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual sleepiness or drowsiness
- unusual tiredness or weakness
Less common
- Chest pain or discomfort
- slow or irregular heartbeat
- trouble breathing
Incidence not known
- Agitation
- anxiety
- bleeding gums
- chest tightness
- coma
- confusion as to time, place, or person
- cool, pale skin
- coughing up blood
- decrease in amount of urine
- depression
- difficulty in speaking
- drowsiness
- fast, pounding, or irregular heartbeat or pulse
- frequent urination
- headache
- holding false beliefs that cannot be changed by fact
- increased hunger
- increased menstrual flow or vaginal bleeding
- irritability
- muscle twitching
- nausea
- nerve pain
- nervousness
- nightmares
- no blood pressure or pulse
- noisy breathing
- nosebleeds
- numbness or tingling in hands, feet, or lips
- pain or discomfort in the arms, jaw, back, or neck
- pale skin
- palpitations
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- restlessness
- seeing, hearing, or feeling things that are not there
- seizures
- shakiness
- slow to respond
- slurred speech
- stomach pain
- stopping of the heart
- swelling of the feet or lower legs
- unconsciousness
- unusual bleeding or bruising
- vomiting
- weakness or heaviness of the legs
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:
More common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Less common
- Dry mouth
- stomach discomfort
Incidence not known
- Diarrhea
- fever
- increased sweating
- seeing flashes or sparks of light
- thirst
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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