Dexmedetomidine (buccal/sublingual)

Dexmedetomidine (buccal/sublingual) is used in adults to help with agitation linked to schizophrenia or bipolar disorder.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

For sublingual use, place dexmedetomidine under your tongue and let it dissolve. Do not swallow or chew.

For buccal use, place dexmedetomidine behind your lower lip and let it dissolve. Do not swallow or chew.

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 monitored during treatment.

You may experience 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.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have any allergies.

Tell your doctor if you have ever had:

• 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;
• long QT syndrome; or
• liver disease.

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.

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

Dexmedetomidine may cause serious side effects. Call your doctor right away if you have:

• fast, slow, or irregular heartbeats; or
• a light-headed feeling, as if you might faint.

Common side effects of dexmedetomidine may include:

• dizziness, drowsiness;
• numbness, tingling, burning pain;
• loss of sensation in the mouth, dry mouth; or
• feeling like you might faint.

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

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.

In a medical setting, you are unlikely to 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.

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

Using dexmedetomidine (buccal/sublingual) with other medications that cause drowsiness can make this effect worse. 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. Inform your doctor about all other medicines you are using.