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 blood or intracranial pressure 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 intracranial pressure. Assess BP prior to & after therapy. Japanese 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
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;2's;3's;6's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in