Dexmedetomidine Sublingual Film

What is this medication?

DEXMEDETOMIDINE (deks MED e toe mi deen) treats agitation due to bipolar disorder or schizophrenia. It works by helping your nervous system calm down.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): IGALMI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Irregular heartbeat or rhythm
• Liver disease
• Low blood pressure
• Slow heartbeat
• An unusual or allergic reaction to dexmedetomidine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. It is given by your care team in a hospital or clinic setting. Your care team will show you how to take this medication. After you put this medication in your mouth as directed, do not move it. Do not chew or swallow it. Do not eat or drink anything for at least 15 minutes after placing the film under the tongue or for at least 1 hour after placing the film inside the lower lip.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, or lorazepam
• Certain antihistamines
• Certain medications for depression, such as amitriptyline or trazodone
• Certain medications for seizures, such as phenobarbital or primidone
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast, irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Dry mouth
• Numbness or tingling of the tongue or mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.