Dexmedetomidine Sublingual and Buccal

WHY is this medicine prescribed?

Dexmedetomidine is used to treat episodes of agitation in people who have schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) or bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods). Dexmedetomidine is in a class of medications called alpha₂ receptor agonists. It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dexmedetomidine comes as a sublingual film to place under the tongue or on the lower gum in your mouth (behind the lower lip). It is usually taken as needed as a single dose under the supervision of a healthcare professional. If you are still agitated after you receive your first dose, you may be given up to 2 more additional doses, given at least 2 hours apart.

To take dexmedetomidine sublingual film, remove the film from the foil pouch with clean dry hands and place the film under your tongue. Alternatively, you can place the film on the lower gum (behind the lower lip). The film will stick in place. Close your mouth and leave the film in place until it dissolves completely. Do not chew or swallow the sublingual film. It may take about 6–8 minutes for the film to dissolve under your tongue or about 18 minutes for the film to dissolve on the lower gum.

Do not eat or drink for at least 15 minutes after the film is placed under your tongue. Do not eat or drink for at least 1 hour after the film is placed on your lower gum (behind your lower lip).

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking dexmedetomidine,

• tell your doctor and pharmacist if you are allergic to dexmedetomidine, any other medications, or any of the ingredients in dexmedetomidine sublingual film. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), fainting spells, low levels of potassium or magnesium in the blood, a slow or irregular heartbeat, high or low blood pressure, diabetes, or heart or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dexmedetomidine, call your doctor.

• you should know that dexmedetomidine may make you drowsy. Do not drive a car or operate machinery for at least 8 hours after you take dexmedetomidine sublingual film.

• you should know that dexmedetomidine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Dexmedetomidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• excessive sleepiness or tiredness
• dizziness
• dry mouth
• mouth numbness
• numbness and tingling of the arms, hands, legs, or feet
• nausea
• stomach pain
• heartburn

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast or irregular heartbeat
• fainting
• dizziness or lightheadedness
• blurred vision

Dexmedetomidine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dexmedetomidine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.