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Dexmedetomidine Sublingual and Buccal

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Why is this medication prescribed?

Schizophrenia (a mental illness that produces confused or strange thinking, loss of interest in life, and intense or inappropriate emotions) and bipolar disorder are two conditions that can cause agitation episodes that can be treated with dexmedetomidine (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods). Alpha2 receptor agonists are a class of drugs that includes dexmedetomidine. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

Dexmedetomidine is available as a sublingual film to be applied to the lower gum or beneath the tongue (behind the lower lip). It is typically administered in a single dose as needed while being closely monitored by a healthcare practitioner. After your first dose, you might have up to two further doses, each given at least two hours apart, if you’re still disturbed.

Dexmedetomidine sublingual film should be taken by placing it under your tongue after being removed from the foil bag with clean, dry hands. You can also apply the film on the lower gum (behind the lower lip). The film will adhere to the surface. Keep the film in place until it totally dissolves while closing your mouth. The sublingual film should not be chewed or ingested. Under your tongue, the film might disintegrate in 6 to 8 minutes, whereas on the lower gum, it might take 18 minutes.

After placing the film under your tongue, wait at least 15 minutes before eating or drinking. After the film is applied to your lower gum, wait at least an hour before eating or drinking (behind your lower lip).

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking dexmedetomidine,

  • If you have an allergy to dexmedetomidine, any other drugs, or any of the ingredients in dexmedetomidine sublingual film, inform your doctor right away. Get a list of the ingredients from your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • A prolonged QT interval (a rare heart condition that can result in an irregular heartbeat, fainting, or sudden death), fainting spells, low blood levels of potassium or magnesium, a slow or irregular heartbeat, high or low blood pressure, diabetes, heart disease, or liver disease should all be mentioned to your doctor.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while taking dexmedetomidine.
  • You should inform your doctor or dentist that you are taking dexmedetomidine if you are having surgery, including dental surgery.
  • You need to be aware that dexmedetomidine could make you sleepy. After taking dexmedetomidine sublingual film, wait at least 8 hours before operating machinery or a vehicle.
  • You should be aware that if you stand up too soon from a laying position after taking dexmedetomidine, you could have dizziness, lightheadedness, and fainting. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

Side effects from dexmedetomidine are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Excessive drowsiness or fatigue
  • Dizziness
  • Mouth ache
  • Mouth feeling numb
  • Tingling and numbness in the hands, feet, legs, or arms
  • Nausea
  • Abdominal pain
  • Heartburn

Certain adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:

  • Rapid or erratic heartbeat
  • Fainting
  • Feeling unsteady or lightheaded
  • Fuzzy vision

Further negative effects of dexmedetomidine are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to dexmedetomidine, your doctor could request specific lab tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Igalmi®
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