Esketamine Hydrochloride (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SPRAY.
Routes of administration: NASAL.
Brand Names
- SPRAVATO
Indications and Usage
SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant
Contraindications
SPRAVATO is contraindicated in patients with: Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation [see Warnings and Precautions (5.7)] History of intracerebral hemorrhage [see Warnings and Precautions (5.7)] Hypersensitivity to esketamine, ketamine, or any of the excipients.
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Sedation [see Warnings and Precautions (5.1)] Dissociation [see Warnings and Precautions (5.2)] Respiratory Depression [see Warnings and Precautions (5.3)] Increase in Blood Pressure [see Warnings and Precautions (5.7)] Cognitive Impairment [see Warnings and Precautions (5.8)] Impaired Ability to Drive and Operate Machinery [see Warnings and Precautions (5.9)] Ulcerative or Interstitial Cystitis [see Warnings and Precautions (5.10)] Embryo-fetal Toxicity [see Warnings and Precautions (5.11)]
Mechanism of Action
Esketamine, the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl- D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. The mechanism by which esketamine exerts its antidepressant effect is unknown. The major circulating metabolite of esketamine (noresketamine) demonstrated activity at the same receptor with less affinity.