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Igalmi (buccal/sublingual)

Generic name: Dexmedetomidine (buccal/sublingual) [DEX-med-e-TOE-mi-deen]
Name of the brand: Igalmi
Classification of drugs: Miscellaneous anxiolytics, sedatives, and other hypnotics

What is Igalmi (buccal or sublingual)?

Igalmi (buccal or sublingual) is used by adult patients to manage the agitation that is a result of schizophrenia or bipolar I or II disorder. The effectiveness and safety that come from dexmedetomidine (buccal or sublingual) have not been confirmed after 24 hours following the initial usage. Igalmi (buccal or sublingual) could also be used for other purposes not covered in this guideline.

Side effects of Igalmi (buccal or sublingual)

Contact a medical professional immediately. If you are experiencing symptoms that are warning signs of an allergic response, such as difficulty breathing, hives, or swelling of your lips, face, and tongue, Igalmi may cause serious side effects. Consult your physician immediately if you experience:

  • Rapid, slow, or irregular heartbeats;
  • Feeling lightheaded, like you're going to faint.

Common negative side effects of Igalmi include:

  • Drowsiness;
  • Dizziness;
  • Numbness, tingling, or burning pain;
  • Loss of sensation in the tongue; dry mouth; loss of taste in the mouth;
  • Feeling like you might pass out.

This is not a comprehensive list of possible side effects, and others could happen. Contact your doctor for advice regarding medical effects. You can report symptoms to the FDA at 1-800-FDA-1088.

Warnings

Take only according to the directions. Inform your doctor if you are taking other medications or have any other medical conditions or allergies.

Prior to use this drug

Speak to your doctor if you are ever diagnosed with:

  • Liver disease;
  • Diabetes;
  • High blood pressure;
  • Low blood pressure or if you are dehydrated
  • An extremely serious heart problem like severe heart blockage;
  • An irregular heartbeat; or
  • Long QT syndrome.

 

It is not clear whether Igalmi (buccal or sublingual) can cause harm to a baby who is not yet born. Consult your physician if you are expecting or planning to become pregnant. If you're nursing, consult your doctor if there is any irritability or discomfort in the baby.

How to take (buccal or sublingual)?

Follow all the instructions on the label of your prescription and read the medication guide or instructions sheets. The doctor might alter your dosage. Make sure you take the medication precisely as directed. Igalmi (buccal or sublingual) is best taken under the direction of a health professional. Apply Igalmi beneath your tongue (sublingual) or behind the lower lip (buccal). Let the film that is dissolving melt, but do not take a bite or swallow Igalmi (buccal or sublingual).

Don't eat or drink for at least 15 minutes following sublingual usage or for at least an hour following oral use. Do not sit or lie down following the use of Igalmi (buccal or sublingual). Your vital indicators could be observed as you undergo the treatment. There may be withdrawal symptoms when you stop taking Igalmi (buccal or sublingual). The most frequent withdrawal symptoms are nausea, vomiting, and agitation. Place Igalmi in the pouch in foil at room temperature away from heat and moisture.

What happens if I miss the dose?

Contact your doctor for advice when you have missed a dose.

What happens if I overdose?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

Avoid driving or engaging in hazardous activities until you understand how Igalmi can affect you. Drowsiness or dizziness can lead to accidents, falls, or serious injuries.

Interaction with other drugs

Igalmi (buccal or sublingual) could cause serious heart conditions. The risk is higher if you take different medicines to treat asthma, pulmonary infections, or heart issues, as well as high blood pressure, depression, cancer, mental illness, malaria, or HIV.

Making use of Igalmi (buccal or sublingual) in conjunction with other medications that cause you to feel drowsy may make it more difficult to get. Consult your physician before taking opioids, a sleeping pill, a muscle relaxant, or medication to treat anxiety and seizures.

Other drugs can also influence Igalmi (buccal/sublingual) It can be affected by other drugs, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Discuss with your doctor all other medicines you take.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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