Precedex (Intravenous)

Dexmedetomidine injection is used to help you sleep (sedate) before or during surgery or other medical procedures. This medicine is also used to sedate intubated and mechanically ventilated patients during treatment in the intensive care unit (ICU).

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important for your doctor to monitor your progress closely while you are using this medicine to ensure it is working correctly and to check for any side effects.

This medicine may cause hypotension (low blood pressure). Contact your doctor immediately if you experience blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from lying down or sitting, sweating, or unusual tiredness or weakness.

Contact your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, a slow or irregular heartbeat, trouble breathing, or unusual tiredness. These may be signs of bradycardia (slow heartbeat).

This medicine may cause hyperthermia (high body temperature). Contact your doctor right away if you experience dizziness, fast, shallow breathing, a fast, weak heartbeat, muscle cramps, pale, clammy skin, thirst, or extremely high fever or body temperature.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Also inform 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 injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of dexmedetomidine injection in the elderly. Nevertheless, elderly patients are more likely to have severe 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 chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using this medication while breastfeeding.

Interactions with Medications

Although certain drugs 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 drug, it is especially important that your healthcare professional know if you are using 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 medication with any of the following drugs 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 normally not recommended, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently 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

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 drug with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Diabetes or
• Heart disease (eg, heart block), serious or
• Heart rhythm issues or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Liver issues—Use with caution. May make these conditions worse.

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
• coughing
• dizziness
• dizziness, faintness, or lightheadedness when getting suddenly up from a lying or sitting position
• headache
• irregular, fast or slow, or shallow breathing
• nervousness
• pale or blue lips, fingernails, or skin
• pounding in the ears
• slow or fast heartbeat
• sweating
• trouble breathing
• unusual tiredness or weakness

Less common

• Bleeding gums
• bloody urine
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• drowsiness
• dry mouth
• extremely high fever or body temperature
• fast, pounding, or irregular heartbeat or pulse
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms or twitching seizures
• nausea
• nosebleeds
• numbness and tingling around the mouth, fingertips, or feet
• pale, clammy skin
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• seizures
• stomach cramps
• swelling of face, fingers, legs, or ankles
• tremor
• unexplained weight gain or loss
• vomiting

Incidence not known

• Chest tightness
• confusion as to time, place, or person
• frequent urination
• holding false beliefs that cannot be changed by fact
• increased volume of pale, dilute urine
• irritability
• no blood pressure
• pain or discomfort in the arms, jaw, back, or neck
• restlessness
• seeing, hearing, or feeling things that are not there
• shakiness
• sleepiness
• slow to respond
• slurred speech
• stomach pain
• stopping of the heart
• unconsciousness
• unusual excitement, nervousness, or restlessness
• weakness or heaviness of the legs
• yellow eyes or skin

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

• Anxiety
• constipation
• shaking

Incidence not known

• Hives, itching, rash
• redness of the skin
• seeing flashes or sparks of light

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.

In the U.S.

• Precedex

Available Dosage Forms:

• Solution

Therapeutic Class: Sedative

Pharmacologic Class: Dexmedetomidine

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed in one of your veins.