Brintellix

Brintellix

vortioxetine

Manufacturer:

Lundbeck Export A/S
Concise Prescribing Info
Contents
Vortioxetine
Indications/Uses
Major depressive disorder in adults.
Dosage/Direction for Use
Adult <65 yr 10 mg once daily, may be increased to a max of 20 mg once daily or decreased to a min of 5 mg once daily depending on individual patient's response. Elderly ≥65 yr Initially 5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ non-selective MAOIs or selective MAO-A inhibitors.
Special Precautions
Closely monitor patients w/ history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to treatment; experiencing aggression, anger, agitation & irritability. Close supervision of high-risk patients should accompany drug therapy. Monitor for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour; signs & symptoms of serotonin syndrome or NMS. Patients w/ history of seizures or unstable epilepsy, mania/hypomania; taking anticoagulants &/or medicinal products known to affect platelet function (& in those w/ known bleeding tendencies/disorders); liver cirrhosis (or concomitant treatment w/ hyponatremia-causing medicinal products), increased IOP or those at risk of acute narrow-angle glaucoma. Discontinue if patient develops seizures or increase in seizure frequency; serotonin syndrome symptoms (eg, mental status changes, autonomic instability, neuromuscular aberrations &/or GI symptoms); in those entering manic phase; w/ symptomatic hyponatremia. Caution when driving or operating hazardous machinery especially when starting treatment or changing the dose. Pregnancy & lactation. Not recommended in childn & adolescents <18 yr. Elderly ≥65 yr (doses >10 mg once daily).
Adverse Reactions
Nausea. Abnormal dreams; dizziness; diarrhoea, constipation, vomiting; pruritus, including generalised pruritus.
Drug Interactions
Risk of serotonin syndrome w/ irreversible non-selective MAOIs; irreversible, selective MAO-B inhibitors (eg, selegiline, rasagiline); serotonergic medicinal products (eg, tramadol, sumatriptan & other triptans). Reversible, selective MAO-A inhibitor eg, moclobemide. Reversible, non-selective MAOI eg, linezolid. Higher AR incidence w/ St. John's wort-containing herbal remedies. Other medicinal products lowering seizure threshold eg, TCAs, SSRIs, SNRIs; neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion, tramadol. Concurrent electroconvulsive therapy (ECT). Increased exposure w/ strong CYP2D6 inhibitors eg, bupropion, quinidine, fluoxetine, paroxetine. Increased AUC w/ ketoconazole or fluconazole. May lead to increased exposure w/ strong CYP3A4 (eg, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, conivaptan & HIV PIs) & CYP2C9 (eg, fluconazole, amiodarone) inhibitors, CYP2D6 poor metabolisers. Decreased AUC w/ CYP450 inducers (eg, rifampicin, carbamazepine, phenytoin). Alcohol (intake is not advisable during treatment). Potential 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
Antidepressants
ATC Classification
N06AX26 - vortioxetine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Brintellix FC tab 10 mg
Packing/Price
28's (Rp560,000/pak)
Form
Brintellix FC tab 20 mg
Packing/Price
28's (Rp1,120,000/pak)
Form
Brintellix FC tab 5 mg
Packing/Price
28's (Rp290,000/pak)
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