Description and Brand Names

Drug information provided by: Merative, Micromedex®

Descriptions

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
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Enflurane
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Famotidine
• Felbamate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Formoterol
• Foscarnet
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Iobenguane I 131
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lofexidine
• Lorazepam
• Loxapine
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Meclizine
• Mefloquine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Metronidazole
• Midazolam
• Mifepristone
• Mizolastine
• Mobocertinib
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nelfinavir
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Ondansetron
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Paliperidone
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranolazine
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sufentanil
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Tetrabenazine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Tilidine
• Tizanidine
• Tolonium Chloride
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

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

1. Blurred vision
2. chills
3. cold sweats
4. confusion
5. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
6. sweating
7. unusual sleepiness or drowsiness
8. unusual tiredness or weakness

Less common

1. Chest pain or discomfort
2. slow or irregular heartbeat
3. trouble breathing

Incidence not known

1. Agitation
2. anxiety
3. bleeding gums
4. chest tightness
5. coma
6. confusion as to time, place, or person
7. cool, pale skin
8. coughing up blood
9. decrease in amount of urine
10. depression
11. difficulty in speaking
12. drowsiness
13. fast, pounding, or irregular heartbeat or pulse
14. frequent urination
15. headache
16. holding false beliefs that cannot be changed by fact
17. increased hunger
18. increased menstrual flow or vaginal bleeding
19. irritability
20. muscle twitching
21. nausea
22. nerve pain
23. nervousness
24. nightmares
25. no blood pressure or pulse
26. noisy breathing
27. nosebleeds
28. numbness or tingling in hands, feet, or lips
29. pain or discomfort in the arms, jaw, back, or neck
30. pale skin
31. palpitations
32. paralysis
33. prolonged bleeding from cuts
34. red or black, tarry stools
35. red or dark brown urine
36. restlessness
37. seeing, hearing, or feeling things that are not there
38. seizures
39. shakiness
40. slow to respond
41. slurred speech
42. stomach pain
43. stopping of the heart
44. swelling of the feet or lower legs
45. unconsciousness
46. unusual bleeding or bruising
47. vomiting
48. 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

1. Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Less common

1. Dry mouth
2. stomach discomfort

Incidence not known

1. Diarrhea
2. fever
3. increased sweating
4. seeing flashes or sparks of light
5. 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.

Portions of this document last updated: June 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/dexmedetomidine-oromucosal-route/before-using/drg-20531865