Igalmi Dosage

Generic name: DEXMEDETOMIDINE 120ug
Dosage form: sublingual film
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Drugs.com. Last updated on Dec 14, 2022.

Important Recommendations Prior to Initiating IGALMI and During Therapy

IGALMI should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope [see Warnings and Precautions (5.5)].

IGALMI is for sublingual or buccal administration. Do not chew or swallow IGALMI. Do not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration.

Recommended Dosage

Table 1 includes dosage recommendations for IGALMI based on agitation severity for adults, patients with hepatic impairment, and geriatric patients. Lower dosages are recommended for patients with hepatic impairment and geriatric patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)].

If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart. The dosage recommendations for additional doses vary depending upon the patient population and agitation severity (see Table 1). Assess vital signs including orthostatic measurements prior to the administration of any subsequent doses.

Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) less than 90 mmHg, diastolic blood pressure (DBP) less than 60 mmHg, heart rate (HR) less than 60 beats per minute, or postural decrease in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg.

Table 1: Dosage Recommendations for IGALMI in Adults, Adult Patients with Hepatic Impairment, and Geriatric Patients with Agitation Associated with Schizophrenia or Bipolar I or II Disorder
Patient Population	Agitation Severity	Initial Dose*	Optional 2nd/3rd Doses*	Maximum Recommended Total Daily Dosage
* IGALMI 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively [see Dosage and Administration (2.3)]. † Hepatic impairment: Mild (Child-Pugh Class A); Moderate (Child-Pugh Class B); Severe (Child-Pugh Class C)
Adults	Mild or Moderate	120 mcg	60 mcg	240 mcg
Adults	Severe	180 mcg	90 mcg	360 mcg
Patients with Mild or Moderate Hepatic Impairment†	Mild or Moderate	90 mcg	60 mcg	210 mcg
Patients with Mild or Moderate Hepatic Impairment†	Severe	120 mcg	60 mcg	240 mcg
Patients with Severe Hepatic Impairment†	Mild or Moderate	60 mcg	60 mcg	180 mcg
Patients with Severe Hepatic Impairment†	Severe	90 mcg	60 mcg	210 mcg
Geriatric Patients (≥ 65 years old)	Mild, Moderate, or Severe	120 mcg	60 mcg	240 mcg

Preparation and Administration Instructions

Keep IGALMI in the foil pouch until ready to administer. IGALMI should be immediately administered once the pouch is opened and the dose prepared.

Prepare and administer IGALMI under the supervision of a healthcare provider as follows:

Healthcare Professional: Prepare IGALMI Dose for Patient
1	Open the sealed foil pouch by tearing straight across at the notch.
Perform Steps 2a, 2b, 2c and 2d only if a 60 mcg or 90 mcg dose (half of a film) is needed, then proceed to Step 3. If administering a full dose (1 film), proceed directly to Step 3.
2a	Remove the film from the pouch with clean dry hands.
2b	Cut the film in half between the dots with clean, dry scissors.
2c	Discard unused half in waste container.
2d	Place the half film for administration to the patient back into the pouch.
3	Immediately give the pouch to the patient.
4	Instruct patient to remove the film from the pouch with clean dry hands.
5	For sublingual administration: Instruct patient to place film under the tongue. The film will stick in place. Note: Patient may not eat or drink for 15 minutes after sublingual administration.
	For buccal administration: Instruct patient to place film behind lower lip. The film will stick in place. Note: Patient may not eat or drink for one hour after buccal administration.
6	Instruct patient to: Close their mouth. Allow the film to dissolve. Do not chew or swallow the film.