Zuellig Pharma
Concise Prescribing Info
Major depressive episodes in adults.
Dosage/Direction for Use
Adult <65 yr Initially 10 mg once daily, may be increased to max: 20 mg once daily or decreased to min: 5 mg once daily. Elderly ≥65 yr Initially 5 mg once daily.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ nonselective MAOIs or selective MAO-A inhibitors.
Special Precautions
Discontinue use if seizures or increased seizure frequency, signs & symptoms of serotonin syndrome or NMS, symptomatic hyponatraemia occur; in patients entering manic phase. Monitor clinical worsening, suicidal behaviour or thoughts, unusual behaviour changes. History of suicide-related events or exhibiting significant degree of suicidal ideation; seizures or unstable epilepsy; mania/hypomania; aggression/agitation; known bleeding tendencies/disorders; mydriasis, increased IOP, at risk of acute narrow-angle glaucoma. Concomitant use w/ anticoagulants &/or drugs affecting platelet function eg, atypical antipsychotics & phenothiazines, most TCAs, NSAIDs, ASA; drugs causing hyponatraemia. Concurrent use w/ electroconvulsive therapy. May affect ability to drive & use machines. Liver cirrhosis. Severe renal & hepatic impairment. Pregnancy & lactation. Not to be used in adolescents 12-17 yr w/ major depressive disorder. Not recommended in childn 7-11 yr. Elderly ≥65 yr.
Adverse Reactions
Nausea. Abnormal dreams; dizziness; diarrhoea, constipation, vomiting; generalised pruritus; hyperhidrosis.
Drug Interactions
Risk of serotonin syndrome w/ irreversible nonselective MAOIs; serotonergic drugs eg, tramadol, sumatriptan, other triptans. Monitor for serotonin syndrome w/ reversible & selective MAO-A inhibitor eg, moclobemide; reversible & nonselective MAOI eg, linezolid; irreversible, selective MAO-B inhibitor eg, selegiline, rasagiline. Higher AR incidence w/ St. John's wort-containing herbal remedies. Medicinal products lowering seizure threshold eg, antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion, tramadol. Increased AUC w/ strong CYP2D6 inhibitor eg, bupropion, quinidine, fluoxetine, paroxetine. Increased exposure w/ strong CYP3A4 (eg, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan, HIV PIs) & CYP2C9 (eg, fluconazole, amiodarone) inhibitors. Decreased AUC w/ rifampicin. Increased risk of bleeding w/ oral anticoagulants or antiplatelets. Enhanced effects w/ lithium or tryptophan. False +ve results in urine enzyme immunoassays for methadone.
MIMS Class
ATC Classification
N06AX26 - vortioxetine ; Belongs to the class of other antidepressants.
Brintellix FC tab 10 mg
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