In conjunction w/ oral antidepressant therapy for treatment-resistant depression (major depressive disorder in adults who have not responded adequately to at least 2 different antidepressants of adequate dose & duration to treat the current depressive episode) & for the rapid reduction of depressive symptoms in adults w/ major depressive disorder who have acute suicidal ideation or behavior.
Treatment-resistant depressionAdultInduction phase Initially 56 mg on day 1, then 56 or 84 mg twice wkly for wk 1-4. Maintenance phase 56 or 84 mg once wkly for wk 5-8, then 56 or 84 mg every 2 wk or once wkly from wk 9. Elderly ≥65 yrInduction phase Initially 28 mg on day 1, then 56 or 84 mg twice wkly for wk 1-4. Subsequent doses should be increased in increments of 28 mg up to 56 or 84 mg based on efficacy & tolerability. Maintenance phase 56 or 84 mg once wkly for wk 5-8, then 56 or 84 mg every 2 wk or once wkly from wk 9. Subsequent doses should be increased in increment of 28 mg up to 56 or 84 mg based on efficacy & tolerability. Major depressive disorder w/ acute suicidal ideation or behavior 84 mg twice wkly for 4 wk. May be reduced to 56 mg based on tolerability. Continue oral antidepressant after 4 wk per clinical judgement.
View Spravato overdosage for action to be taken in the event of an overdose.
Contraindications
Hypersensitivity to esketamine or ketamine. Patients for whom an increase in BP or ICP poses a serious risk eg, those w/ known aneurysmal vascular disease (including intracranial, thoracic or abdominal aorta, or peripheral arterial vessels) or history of intracerebral hemorrhage.
For nasal use only. Prevention of suicide or reduction of suicidal ideation or behavior. Does not preclude need for hospitalization if clinically warranted even if patients experience improvement after initial dose. Closely monitor patients for clinical worsening or emergence of suicidal thoughts & behaviors, especially during initial few mth of therapy & at times of dosage changes. Greater risk of suicidal thoughts or attempts in patients w/ history of suicide related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment. Carefully assess patients w/ CV & cerebrovascular conditions prior to prescribing including those w/ unstable or poorly controlled HTN, history (w/in 6 wk) of CV event including MI, history (w/in 6 mth) of ischemic stroke or transient ischemic attack, hemodynamically significant valvular heart disease (eg, mitral regurgitation, aortic stenosis or aortic regurgitation), NYHA class III-IV heart failure of any etiology. Administration can temporarily raise BP lasting approx 1-2 hr; assess BP prior to dosing. Closely monitor BP in concomitant use w/ psychostimulants or MAOIs. Potential for cognitive (short- & long-term) & motor impairment. Patients w/ history of drug abuse or dependence; substance use disorder including alcohol; presence or history of psychosis, mania or bipolar disorder; hyperthyroidism that has not been sufficiently treated; significant pulmonary insufficiency; known uncontrolled brady or tachyarrhythmias that lead to hemodynamic instability; history of brain injury, hypertensive encephalopathy, intrathecal therapy w/ ventricular shunts, or any other condition associated w/ increased ICP. Do not engage in potentially hazardous activities requiring complete mental alertness & motor coordination (eg, driving motor vehicle or operating machinery) until the next day following a restful sleep. Not recommended in severe hepatic impairment (Child-Pugh class C). Women of reproductive potential should use highly effective contraception during & up to 6 wk after last treatment. Not recommended during pregnancy & lactation. Childn ≤17 yr. Japanese & Chinese patients.
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