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Igalmi Generic Name & Formulations
Legal Class
Rx
General Description
Dexmedetomidine 120mcg, 180mcg; sublingual film; contains peppermint oil, sucralose.
Pharmacological Class
Alpha-2 agonist.
How Supplied
Films—10, 30
Manufacturer
Generic Availability
NO
Igalmi Indications
Indications
Acute treatment of agitation associated with bipolar I or II disorder.
Limitations of Use
Safety and efficacy have not been established beyond 24hrs from the first dose.
Igalmi Dosage and Administration
Adult
Give by sublingual or buccal administration. Do not chew or swallow. Films may cut in half to obtain 60mcg and 90mcg doses. Avoid food or drinks for at least 15mins after sublingual administration or at least 1hr after buccal administration. If agitation persists after the initial dose, repeat up to 2 additional doses at least 2hrs apart. For agitation severity (mild to moderate): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg; (severe): initially 180mcg, may give 2nd/3rd doses of 90mcg for a max total daily dose of 360mcg. Patients with mild to moderate hepatic impairment: agitation severity (mild to moderate): initially 90mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 210mcg; (severe): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg. Patients with severe hepatic impairment: agitation severity (mild to moderate): initially 60mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 180mcg; (severe): initially 90mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 210mcg. Elderly (≥65yrs): agitation severity (mild, moderate, or severe): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg.
Children
Not established.
Igalmi Contraindications
Not Applicable
Igalmi Boxed Warnings
Not Applicable
Igalmi Warnings/Precautions
Warnings/Precautions
Administer under the supervision of a healthcare provider. Increased hypotension and/or bradycardia esp. in those with hypovolemia, diabetes mellitus, or chronic hypertension, and in elderly patients. Avoid in hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope. Additional half-doses are not recommended in those with systolic BP <90mmHg, diastolic BP <60mmHg, HR <60 beats/min, or postural decrease in systolic BP ≥20mmHg or in diastolic BP ≥10mmHg. Ensure adequate hydration. Advise patients to sit or lie down after administration until vitals are within normal range. QT interval prolongation. Avoid in patients at risk of torsades de pointes or sudden death including those with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia or hypomagnesemia. Risk of physical dependence, withdrawal reactions, tolerance and tachyphylaxis if treatment is used other than indicated. Hepatic impairment, elderly (≥65yrs): reduce dose (see Adult). Pregnancy. Nursing mothers.
Igalmi Pharmacokinetics
See Literature
Igalmi Interactions
Interactions
Avoid concomitant other drugs known to prolong the QT interval. Concomitant anesthetics, sedatives, hypnotics, or opioids may potentiate CNS depressant effects; consider reduction in dosage of either Igalmi or concomitant drug.
Igalmi Adverse Reactions
Adverse Reactions
Somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, orthostatic hypotension.
Igalmi Clinical Trials
See Literature
Igalmi Note
Not Applicable
Igalmi Patient Counseling
See Literature
Igalmi Generic Name & Formulations
Legal Class
Rx
General Description
Dexmedetomidine 120mcg, 180mcg; sublingual film; contains peppermint oil, sucralose.
Pharmacological Class
Alpha-2 agonist.
How Supplied
Films—10, 30
Manufacturer
Generic Availability
NO
Igalmi Indications
Indications
Acute treatment of agitation associated with schizophrenia.
Limitations of Use
Safety and efficacy have not been established beyond 24hrs from the first dose.
Igalmi Dosage and Administration
Adult
Give by sublingual or buccal administration. Do not chew or swallow. Films may cut in half to obtain 60mcg and 90mcg doses. Avoid food or drinks for at least 15mins after sublingual administration or at least 1hr after buccal administration. If agitation persists after the initial dose, repeat up to 2 additional doses at least 2hrs apart. For agitation severity (mild to moderate): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg; (severe): initially 180mcg, may give 2nd/3rd doses of 90mcg for a max total daily dose of 360mcg. Patients with mild to moderate hepatic impairment: agitation severity (mild to moderate): initially 90mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 210mcg; (severe): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg. Patients with severe hepatic impairment: agitation severity (mild to moderate): initially 60mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 180mcg; (severe): initially 90mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 210mcg. Elderly (≥65yrs): agitation severity (mild, moderate, or severe): initially 120mcg, may give 2nd/3rd doses of 60mcg for a max total daily dose of 240mcg.
Children
Not established.
Igalmi Contraindications
Not Applicable
Igalmi Boxed Warnings
Not Applicable
Igalmi Warnings/Precautions
Warnings/Precautions
Administer under the supervision of a healthcare provider. Increased hypotension and/or bradycardia esp. in those with hypovolemia, diabetes mellitus, or chronic hypertension, and in elderly patients. Avoid in hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope. Additional half-doses are not recommended in those with systolic BP <90mmHg, diastolic BP <60mmHg, HR <60 beats/min, or postural decrease in systolic BP ≥20mmHg or in diastolic BP ≥10mmHg. Ensure adequate hydration. Advise patients to sit or lie down after administration until vitals are within normal range. QT interval prolongation. Avoid in patients at risk of torsades de pointes or sudden death including those with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia or hypomagnesemia. Risk of physical dependence, withdrawal reactions, tolerance and tachyphylaxis if treatment is used other than indicated. Hepatic impairment, elderly (≥65yrs): reduce dose (see Adult). Pregnancy. Nursing mothers.
Igalmi Pharmacokinetics
See Literature
Igalmi Interactions
Interactions
Avoid concomitant other drugs known to prolong the QT interval. Concomitant anesthetics, sedatives, hypnotics, or opioids may potentiate CNS depressant effects; consider reduction in dosage of either Igalmi or concomitant drug.
Igalmi Adverse Reactions
Adverse Reactions
Somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, orthostatic hypotension.
Igalmi Clinical Trials
See Literature
Igalmi Note
Not Applicable
Igalmi Patient Counseling
See Literature
