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Spravato
esketamine nasal
Black Box Warnings .
Appropriate Use
restricted distribution program (Spravato REMS) due to risk of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse and misuse; healthcare settings and pharmacies must be certified, and pts treated in outpatient healthcare settings must be enrolled in the program; 1-855-382-6022 or www.spravatorems.com for more information
Sedation, Dissociation, Respiratory Depression
risk of sedation, dissociative or perceptual changes after esketamine admin; respiratory depression observed post-marketing; monitor pts for at least 2h at each tx session, then assess when pt is clinically stable and ready to leave healthcare setting
Abuse and Misuse
esketamine has potential to be abused and misused; weigh risk/benefit in pts at higher risk of abuse; monitor for s/sx of abuse and misuse
Suicidality
antidepressants incr. suicidality risk in peds and young adult pts in short-term studies; monitor closely for clinical worsening and suicidality; advise families and caregivers of need for close observation and communication w/ prescriber; not approved for peds pts
Adult Dosing .
Dosage forms: SPRAY: 28 mg per device
Restricted Distribution in US
- [1-855-382-6022 or www.spravatorems.com for more info]
Special Note
- [dosing clarification]
- Info: each device delivers 2 sprays
major depressive disorder, tx-resistant
- [induction phase]
- Dose: 56-84 mg intranasally 2x/wk x4wk; Info: evaluate benefit after 4wk before cont. tx; alternate nostrils w/ each spray; give 5min rest between each device use; avoid food >2h and drink >30min before admin.
- [maintenance phase]
- Dose: 56-84 mg intranasally qwk x4wk, then 56-84 mg intranasally q1-2wk; Info: alternate nostrils w/ each spray; give 5min rest between each device use; avoid food >2h and drink >30min before admin.
major depressive disorder, depressive sx - acutely suicidal pts
- [84 mg intranasally 2x/wk x4wk]
- Info: use w/ oral antidepressant; may decr. dose to 56 mg intranasally 2x/wk based on tolerability; evaluate benefit after 4wk before cont. tx; alternate nostrils w/ each spray; give 5min rest between each device use; avoid food >2h and drink >30min before admin.
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: not defined; moderate impairment: not defined, caution advised; severe impairment: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.