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Treatment resistant major depression Clinical criteria: Treatment Phase: Induction treatment The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies. Treatment criteria: Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist, AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The following must apply if reinitiating treatment: (i) at least four-week gap from last treatment course to reinitiation of treatment; and (ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and (iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression. The listed quantity of 24 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the induction treatment setting.
“It is a non-selective, non-competitive, antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.”
“The mean terminal half-life following administration as a nasal spray generally ranged from 7 to 12 hours.”
“The main CYP enzymes responsible for esketamine N-demethylation are CYP2B6 and CYP3A4. Other CYP enzymes, including CYP2C19 and CYP2C9, contribute to a much smaller extent.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.