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dexmedetomidine (buccal/sublingual)

Pronunciation: DEX med e TOE mi deen

Brand: Igalmi

What is the most important information I should know about dexmedetomidine (buccal/sublingual)?

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

What is dexmedetomidine (buccal/sublingual)?

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.

What should I discuss with my healthcare provider before using dexmedetomidine (buccal/sublingual)?

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.

How should I use dexmedetomidine (buccal/sublingual)?

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 this medicine in the foil pouch at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

What should I avoid while using dexmedetomidine (buccal/sublingual)?

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

What are the possible side effects of dexmedetomidine (buccal/sublingual)?

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

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 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.

What other drugs will affect dexmedetomidine (buccal/sublingual)?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about dexmedetomidine (buccal/sublingual).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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