Dexmedetomidine (Oromucosal route)

Pronunciation:

dex-me-de-TOE-mi-deen

Classifications:

Pharmacologic—

Alpha-2 Adrenergic Agonist

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other medicines—

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
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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 11/16/2023

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