Spravato

Spravato

esketamine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Esketamine
Indications/Uses
In combination w/ SSRIs or SNRIs for adults w/ treatment-resistant major depressive disorder (MDD) who have not responded to at least 2 different treatments w/ antidepressants in current moderate to severe depressive episode. In conjunction w/ oral antidepressant for depressive symptoms in adults w/ MDD w/ acute suicidal ideation or behavior.
Dosage/Direction for Use
Adult <65 yr Induction phase Initially 56 mg on day 1, then 56 or 84 mg twice wkly for wk 1-4. Maintenance phase 56 or 84 mg once wkly for wk 5-8, then 56 or 84 mg every 2 wk or once wkly from wk 9. Elderly ≥65 yr Induction phase Initially 28 mg on day 1, then 28, 56 or 84 mg twice wkly for wk 1-4. Dose changes should be made in 28-mg increments. Maintenance phase 28, 56 or 84 mg once wkly for wk 5-8, then 28, 56 or 84 mg every 2 wk or once wkly from wk 9. Dose changes should be made in 28-mg increments. Moderate hepatic impairment Max dose: 84 mg. Depressive symptoms in adult w/ MDD w/ acute suicidal ideation or behavior 84 mg twice wkly for 4 wk, may be reduced to 56 mg twice wkly based on tolerability.
Contraindications
Hypersensitivity to esketamine, ketamine. Patients whom increased BP or ICP poses serious risk eg, patients w/ aneurysmal vascular disease including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels; history of intracerebral haemorrhage; recent (w/in 6 wk) CV event including MI.
Special Precautions
Not to be used in preventing suicide, reducing suicidal ideation or behavior. Not approved as an anesth agent. Neuropsychiatric & motor impairments; resp depression. Clinically significant or unstable CV or resp conditions eg, significant pulmonary insufficiency including COPD; sleep apnoea w/ morbid obesity (BMI ≥35); uncontrolled brady- or tachyarrhythmias leading to haemodynamic instability; history of MI; haemodynamically significant valvular heart disease or NYHA class III-IV heart failure. Urinary tract & bladder symptoms. Patients w/ history of suicide-related events or exhibiting significant degree of suicidal ideation; history of drug abuse or dependence. Presence or history of psychosis, mania or bipolar disorder; insufficiently-treated hyperthyroidism; history of brain injury, hypertensive encephalopathy, intrathecal therapy w/ ventricular shunts or other conditions associated w/ increased ICP. Assess BP prior to & after therapy. Japanese & Chinese patients. Prolonged use. Concomitant use w/ CNS depressants. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh C). Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Suicidality in childn & adolescents. Paed patients ≤17 yr. Elderly ≥65 yr.
Adverse Reactions
Dissociation; dizziness, headache, dysgeusia, somnolence, hypoaesthesia; vertigo; nausea, vomiting. Euphoric mood, agitation, anxiety, illusion, irritability, panic attack, altered time perception, hallucination including visual hallucination, derealisation; mental impairment, tremor, lethargy, dysarthria, paraesthesia, sedation; blurred vision; hyperacusis, tinnitus; tachycardia; HTN; nasal discomfort & dryness including nasal crusting & pruritus; dry mouth, oral hypoaesthesia; hyperhidrosis; pollakiuria, dysuria, micturition urgency; feeling abnormal, drunk & body temp change; increased BP.
Drug Interactions
Increased sedation w/ CNS depressants eg, benzodiazepines, opioids, alcohol. Closely monitor BP w/ psychostimulants eg, amphetamines, methylphenidate, modafinil, armodafinil or other medicinal products increasing BP eg, xanthine derivatives, ergometrine, thyroid hormones, vasopressin or MAOIs (eg, tranylcypromine, selegiline, phenelzine).
MIMS Class
Antidepressants
ATC Classification
N06AX27 - esketamine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Spravato nasal spray 28 mg/2 sprays
Packing/Price
1's
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