Dexmedetomidine (buccal/sublingual) is used in adults to treat agitation associated with schizophrenia or bipolar I or II disorder.

The safety and effectiveness of dexmedetomidine (buccal/sublingual) has not been established after 24 hours from the first use.

Dexmedetomidine (buccal/sublingual) may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Dexmedetomidine (buccal/sublingual) should be administered under the supervision of a healthcare professional.

Place dexmedetomidine under the tongue (sublingual) or behind the lower lip (buccal).

Allow the dissolving film to dissolve, and do not chew or swallow dexmedetomidine (buccal/sublingual).

Do not eat or drink for at least 15 minutes after sublingual use, or at least one hour after buccal use.

Remain sitting or lying down after using dexmedetomidine (buccal/sublingual).

Your vital signs may be watched during treatment.

You may have withdrawal symptoms after you stop using dexmedetomidine (buccal/sublingual). The most common withdrawal reactions are nausea, vomiting, and agitation.

Store dexmedetomidine in the foil pouch at room temperature away from moisture and heat.

Usual Adult Dose for Sedation:

Intensive Care Unit Sedation:
-Initial Dose: Loading dose of 1 mcg/kg IV infusion over 10 minutes.
-Maintenance Dose: 0.2 to 0.7 mcg/kg/hour IV infusion; adjust the infusion rate to achieve the desired clinical effect.

Procedural Sedation:
-Initial Dose (including Awake Fiberoptic Intubation): 1 mcg/kg IV infusion over 10 minutes.
-Maintenance Dose: Initiate IV infusion at 0.6 mcg/kg/hour and titrate to achieve the desired clinical effect; doses may range from 0.2 to 1 mcg/kg/hour.

Uses: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; sedation of non-intubated patients prior to and/or during surgical and other procedures.

Usual Geriatric Dose for Sedation:

Over Age 65 Years:
Intensive Care Unit Sedation: Dose reduction may be required; however, no specific guidelines have been suggested.

Procedural Sedation:
-Initial Dose: May be omitted or reduced (e.g., 0.5 mcg/kg IV infusion over 10 minutes).
-Maintenance Dose: Dose reduction may be required; however, no specific guidelines have been suggested.

Uses: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; sedation of non-intubated patients prior to and/or during surgical and other procedures.

Tell your doctor if you have ever had:

• liver disease;

• diabetes;

• high blood pressure;

• low blood pressure, or if you are dehydrated;

• a serious heart condition such as severe heart block;

• a heart rhythm disorder; or

• long QT syndrome.

It is not known if dexmedetomidine (buccal/sublingual) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are breastfeeding, tell your doctor if you notice irritability in the nursing baby.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how dexmedetomidine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dexmedetomidine may cause serious side effects. Call your doctor at once if you have:

• fast, slow, or irregular heartbeats; or

• a light-headed feeling, like you might pass out.

Common side effects of dexmedetomidine may include:

• drowsiness;

• dizziness;

• numbness, tingling, burning pain;

• loss of sensation in the mouth, dry mouth; or

• feeling like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dexmedetomidine (buccal/sublingual) can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using dexmedetomidine (buccal/sublingual) with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect dexmedetomidine (buccal/sublingual), including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.