Firma Welfare Instrument
SB Pharma
Concise Prescribing Info
Dosage/Direction for Use
Adult Initially 15 or 30 mg. Effective daily dose: 15-45 mg.
May be taken with or without food: Place tab on tongue & allow to disintegrate then swallow w/ water or other liqd.
Hypersensitivity. Concomitant use w/ MAOIs or w/in 2 wk after discontinuation of MAOIs.
Special Precautions
Risk of suicide/suicidal thoughts or clinical worsening; bone marrow depression; jaundice; akathisia/psychomotor restlessness; hyponatremia; serotonin syndrome. Patients w/ epilepsy & organic brain syndrome; hepatic or renal impairment; cardiac disease eg, conduction disturbance, angina pectoris & recent MI; low BP; DM; schizophrenia or other psychotic disturbances; history of mania/hypomania; micturition disturbances, acute narrow-angle glaucoma & increased IOP; known CVD or family history of QT prolongation & concomitant use w/ other medicines that may prolong the QTc interval; patients w/ phenylketonuria. Abrupt termination of treatment may result in w/drawal symptoms. Concomitant use w/ other serotonergic active substances. Minor to moderate influence on the ability to drive & use machines. Pregnancy & lactation. Not to be used in childn & adolescent <18 yr. Elderly.
Adverse Reactions
Increased wt & appetite; somnolence, sedation, headache; dry mouth. Abnormal dreams, confusion, anxiety, insomnia; lethargy, dizziness, tremor; orthostatic hypotension; constipation, nausea, diarrhoea, vomiting; exanthema; arthralgia, myalgia, back pain; peripheral oedema, fatigue.
Drug Interactions
Increased incidence of serotonin-associated effects w/ MAOIs or other serotonergic active substances (L-tryptophan, triptans, tramadol, linezolid, methylene blue, SSRIs, venlafaxine, lithium, St. John's Wort). May increase the sedating properties of benzodiazepines & other sedatives. May increase CNS depressant effect of alcohol. Increased INR w/ warfarin. Increased risk of QT prolongation &/or ventricular arrhythmias w/ concomitant use of medicines which prolong the QTc interval (eg, some antipsychotics & antibiotics). Decreased plasma conc w/ carbamazepine & phenytoin (CYP3A4 inducers). Increased peak plasma levels & AUC w/ potent CYP3A4 inhibitors (ketoconazole, HIV PIs, azole antifungals, erythromycin, cimetidine or nefazodone).
MIMS Class
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
Mirta orodispersible tab 15 mg
3 × 10's
Mirta orodispersible tab 30 mg
3 × 10's
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