J-C Health Care Ltd., Israel

NMDA Antagonist. Esketamine 28 mg/vail.
Sol. for nasal spray.2/3 vials.
Adlts. <65 years with treatment-resistant Major Depress. Disord.
Weeks 1-4: Starting day 1 dose: 56 mg.
Subsequent doses: 56 mg or 84 mg twice a week.
Maint: Weeks 5-8: 56 mg or 84 mg once weekly. From week 9: 56 mg or 84 mg every 2 weeks or once weekly. After depress. sympt. improve, tmt. is recommend. for at least 6 months.
Adlts.>65 years with treatment-resistant Major Depress. disord.
Weeks 1-4: Starting day 1 dose: 28 mg.
Subsequent doses: 28, 56 or 84 mg twice a week.
Maint: Weeks 5-8: 28, 56 or 84 mg once weekly. From week 9: 28, 56 or 84 mg every 2 weeks or once weekly. After depress. sympt. improve, tmt. is recommend. for at least 6 months.
Acute short-term treatment of psychiatr. emerg. due to Major Depress. Disord.:
Adlt. pts. (<65 years) : 84 mg twice per week for 4 weeks. Dose reduct. to 56 mg should be made based on tolerab. After 4 weeks of tmt., oral antidepressant (AD) ther. should be contin.
See full prescr. details for older pts.
In combinat. with a SSRI or SNRI, for adlts with tmt.-resist. Major Depress. Disord., who have not respond. to at least two diff. tmt. with antidepr. in the curr. mod. to sev. depress. episode.
Co-administr. with oral antidepress. ther., indic. in adlts with a moder. to sev. episode of Major Depress. Disord, as acute short-term tmt., for the rapid reduct. of depress. sympt., which accord. to clin. judgem. constitute a psych. emerg.
Limitations of Use: The effectiv. of this drug in prevent. suicide or in reducing suicidal ideat. or behavior has not been demonstr. Use of this drug does not preclude the need for hospitaliz. if clinic. warranted, even if pts. experience improvem. after an initial dose.
C/I:  Hypersens. to act. subst., ketamine, or to any of the excipients. Pts. for whom an increase in BP or intracran. press. poses a ser. risk. Pts. with aneurysmal vasc. dis. (includ. intracran., thorac., or abdom. aorta, or periph. art. vessels). Pts. with hist. of intracerebr. haemorrhage.  Recent (within 6 weeks) CV event, includ. myocard. infarct. (MI).