Dexmedetomidine (dex-me-de-TOE-mi-deen)

Treats agitation caused by schizophrenia or bipolar disorder (manic-depressive illness).

Brand Name(s):

Igalmi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Thin Sheet

• A nurse or other trained health professional will give you this medicine. This medicine is a film that is given under the tongue (sublingual) or behind the lower lip (buccal).
• 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.
• 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 the medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dexmedetomidine works. Tell your doctor if you are using medicine that may cause heart rhythm problems.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems, high or low blood pressure, diabetes, electrolyte imbalance, or a history of fainting.
• This medicine may cause the following problems:
  • Hypotension (low blood pressure)
  • Bradycardia (slow heartbeat)
  • Heart rhythm problems, including QT prolongation
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly. You may feel lightheaded if you get up suddenly from a lying or sitting position.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting, dizziness, lightheadedness
• Fast, slow, pounding, or uneven heartbeat
• Sleepiness or unusual drowsiness

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088