Mirzentac

Mirzentac

mirtazapine

Manufacturer:

Whan In Pharm

Distributor:

SB Pharma
Concise Prescribing Info
Contents
Mirtazapine
Indications/Uses
Major depression episodes in adults.
Dosage/Direction for Use
Adult/elderly Starting dose: 15 or 30 mg. Effective dose: 15-45 mg once daily. Increase up to max dose w/ insufficient response. Preferably taken as a single night-time dose before going to bed. May also be given in 2 divided doses (once in the morning & once at night-time, higher dose taken at night). Treat patients for a sufficient period of at least 6 mth.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs.
Special Precautions
Discontinue treatment gradually to avoid w/drawal symptoms. Do not start serotonergic psychiatric drugs in a patient receiving linezolid; wait until 24 hr after the last dose of linezolid before starting serotonergic psychiatric drugs. Closely monitor patients until improvement occurs. Suicide risk may increase in the early stages of recovery. Patients w/ history of suicide-related events or those exhibiting significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, & should receive careful monitoring during treatment. Reports of severe cutaneous adverse reactions, including SJS, TEN, DRESS, bullous dermatitis & erythema multiforme; bone marrow depression, usually presenting as granulocytopenia or agranulocytosis. Discontinue treatment if jaundice occurs. Careful dosing & regular & close monitoring is necessary in patients w/ epilepsy & organic brain syndrome; hepatic impairment; renal impairment; cardiac diseases like conduction disturbances, angina pectoris & recent MI; low BP; DM. Risk of worsening of psychotic symptoms in patients w/ schizophrenia or other psychotic disturbances; intensified paranoid thoughts; depressive phase of bipolar disorder transforming into manic phase during treatment. Caution in patients w/ micturition disturbances like prostate hypertrophy & in patients w/ acute narrow-angle glaucoma & increased IOP. Associated w/ development of akathisia, most likely to occur w/in the 1st few wk of treatment. Reports of cases of QT prolongation, torsades de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest, & sudden death, majority in association w/ overdose or in patients w/ other risk factors for QT prolongation. Caution in patients at risk of hyponatraemia. Interaction w/ serotonergic active substances. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Elderly. Do not use in childn & adolescents <18 yr.
Adverse Reactions
Increased wt, increase in appetite; somnolence, sedation, headache; dry mouth. Abnormal dreams, confusion, anxiety, insomnia; lethargy, dizziness, tremor, amnesia; orthostatic hypotension; nausea, diarrhea, vomiting, constipation; exanthema; arthralgia, myalgia, back pain; oedema peripheral, fatigue.
Drug Interactions
Do not concomitantly administer w/ MAOIs or w/in 2 wk after discontinuation of MAOI therapy; about 2 wk should pass before treating mirtazapine-treated patients w/ MAOIs. Serotonin syndrome w/ serotonergic active substances (L-tryptophan, triptans, tramadol, methylene blue, SSRIs, venlafaxine, lithium & St. John's wort prep). Increased sedating properties of benzodiazepines & other sedatives (antipsychotics, antihistamine H1 antagonists, opioids). Increased CNS depressant effect of alcohol. Statistically significant increase in INR w/ warfarin. Increased risk of QT prolongation &/or ventricular arrhythmias (eg, torsades de pointes) w/ QTc interval-prolonging medicines (eg, some antipsychotics & antibiotics). Increased clearance w/ carbamazepine & phenytoin (CYP3A4 inducers). Increased peak plasma levels & AUC w/ ketoconazole (potent CYP3A4 inhibitor). Increased mean plasma conc w/ cimetidine (weak inhibitor of CYP1A2, CYP2D6 & CYP3A4). Decrease dose when co-administering w/ potent CYP3A4 inhibitors, HIV PIs, azole antifungals, erythromycin, cimetidine or nefazodone.
MIMS Class
Antidepressants
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Mirzentac FC tab 15 mg
Packing/Price
3 × 10's
Form
Mirzentac FC tab 30 mg
Packing/Price
3 × 10's
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