FDA Schedule III Forms: 28mg nasal spray Dose Range: 56-84 mg/day Starting:
In conjunction with an oral antidepressant and under supervision of a healthcare provider
Day 1 starting dose: 56 mg
Administer twice per week
Subsequent doses: 56 mg or 84 mg
Weeks 5 to 8:
Administer once weekly
56 mg or 84 mg
Week 9 and after:
Administer weekly or Q2 weeks
56 mg or 84 mg
Assess BP before & after administration. Monitor patients (for sedation & dissociation) for 2° after administration. To avoid N/V, avoid food for at least 2°, & liquids at least 30 minutes, prior to administration.
Contraindications: Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or AVM; h/o intracerebral hemorrhage. Serious Side Effects: D/t risks of sedation and dissociation, patients must be monitored for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Patients should not engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep Has potential for abuse/misuse.
The totality of evidence from the nonclinical and clinical data indicates a lack of clinically relevant QTc prolongation at the therapeutic dose of esketamine.
Side Effects: dizziness, nausea, anxiety, vomiting, hypertension, vertigo, cognitive impairment, dissociation (61% to 75%), hypoesthesia, feeling drunk, sedation/somnolence (49% to 61%)
- Pharmacokinetically, as a substrate of 2B6 and 3A4, coprescribed inhibitors and inducers can increase or decrease esketamine levels, respectively. As an inducer of 2B6 and 3A4, esketamine can decrease levels of other co-prescribed 2B6 and 3A4 substrates
- Pharmacodynamically, use caution when coprescribing with other potentially CNS-depressing agents.
- Available only through a restricted program under a REMS called the SPRAVATO REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse
The nasal spray device delivers a total of 28mg of esketamine. To prevent loss of medication, do not prime the device before use. Use 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device.
Causes ↑ in systolic and/or diastolic BP at all recommended doses. BP ↑ peaks ~40minutes after administration and last ~4 hours. Approximately 8%-7% of patients (vs 1%-3% given placebo) experienced an ↑ of more >40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks of tx.
Category Not classified.—May cause fetal harm when administered to pregnant women.
Esketamine is present in human milk. There are no data on the effects of esketamine on the breastfed infant or on milk production. Published studies in juvenile animals report neurotoxicity. Because of the potential for neurotoxicity, advise patients that breast-feeding is not recommended during treatment.
No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.
No dosage adustment necessary.
The mean esketamine AUC and t1/2 values were higher in patients with moderate hepatic impairment compared to those with normal hepatic function; ∴ patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time. Esketamine has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in this population is not recommended.
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Last updated March 09 2019 12:10:32. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.
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