Generic Medicine Info
May be taken with or without food.
Concomitant or within 14 days of discontinuing MAOIs including linezolid and IV methylene blue.
Special Precautions
Patient with suicidal ideation, bipolar disorder, known or history of seizure disorder, benign prostatic hyperplasia, paralytic ileus, urinary retention, visual disturbances, volume depletion, diabetes mellitus, CV or cerebrovascular disease, risk factors for QT prolongation, hypotension, angle-closure glaucoma, increased intraocular pressure. Dehydrated patients. Renal and hepatic impairment. Pregnancy and lactation. Patient Counselling This drug may cause somnolence, if affected, do not drive or operate machinery. Monitoring Parameters Screen for personal or family history of bipolar disorder prior to initiation of therapy. Monitor for suicidal thoughts during early antidepressant therapy and period of dosage adjustment; signs of altered mental status (e.g. depression, anxiety, mania, panic attacks), signs of agranulocytosis (e.g. sore throat, fever, stomatitis), signs of serotonin syndrome, eyes, renal, hepatic and cardiac function. Monitor blood pressure, serum electrolytes, lipid profile, blood sugar and CBC.
Adverse Reactions
Significant: Akathisia, anticholinergic effects (e.g. blurred vision, constipation, xerostomia), arrhythmia, agranulocytosis, hyperlipidaemia, hyponatraemia, increased sedation, increased risk of suicidal ideation, angle-closure glaucoma, orthostatic hypotension, increased transaminase levels, increased appetite, weight gain. Blood and lymphatic system disorders: Anaemia, leucopenia, lymphocytosis, pancytopenia and thrombocytopenia. Cardiac disorders: Angina pectoris, bradycardia, myocardial infarction. Ear and labyrinth disorders: Deafness, hyperacusis, otitis media. Endocrine disorders: Goitre, hyperprolactinaemia. Eye disorders: Abnormal accommodation, abnormal lacrimation, conjunctivitis, diplopia, blepharitis, eye pain. Gastrointestinal disorders: Abdominal pain, acute abdominal syndrome, colitis, constipation, diarrhoea, dry mouth, abdomen enlarged, eructation, gastritis, glossitis, hiccup, intestinal obstruction, pancreatitis, salivary gland enlargement, stomatitis, tongue discolouration, nausea, vomiting, ulcer. General disorders and administration site conditions: Abnormal healing, asthenia, ataxia, fatigue, fever, malaise, oedema. Hepatobiliary disorders: Cholecystitis, jaundice, liver cirrhosis. Injury, poisoning and procedural complications: Asphyxia, bone fracture, phlebitis, tendon rupture. Investigations: Increased acid phosphatase, increased creatine kinase. Metabolism and nutrition disorders: Anorexia, frequent thirst, dehydration, peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis, back pain, bursitis, gout, hypotonia, myalgia, myositis, neck rigidity, rhabdomyolysis, tenosynovitis. Nervous system disorders: Agitation, amnesia, cerebral ischaemia, convulsions, dizziness, dyskinesia, dystonia, extrapyramidal syndrome, headache, hypokinesia, hypoaesthesia, nystagmus, myasthenia, myoclonus, migraine, paralysis, paraesthesia, restless legs syndrome, stupor, tremors, vertigo. Psychiatric disorders: Anxiety, apathy, aphasia, confusion, delirium, delusions, dementia, depersonalization, depression, dysarthria, emotional lability, euphoria, hallucination, hostility, insomnia, manic reaction, neurosis, paranoid reaction, somnolence, abnormal dreams or thinking. Renal and urinary disorders: Cystitis, dysuria, polyuria, urinary frequency, urinary retention, UTI. Reproductive system and breast disorders: Breast engorgement and enlargement, amenorrhoea, dysmenorrhoea, haematuria, increased libido, leucorrhoea, metrorrhagia, impotence. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, bronchitis, asthma, laryngitis, flu syndrome, pneumonia, pneumothorax, pulmonary embolus, sinusitis. Skin and subcutaneous tissue disorders: Acne, alopecia, exanthema, erythema multiforme, exfoliative dermatitis, urticaria, herpes simplex, herpes zoster, petechiae, rash, seborrhoea, skin hypertrophy, skin photosensitivity. Vascular disorders: Epistaxis, hypertension, hypotension, syncope, vasodilation.
Potentially Fatal: Serotonin syndrome, severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).
Drug Interactions
Increased sedative effects with benzodiazepines (e.g. alprazolam, clonazepam, diazepam). Increased risk of serotonin syndrome with SSRIs (e.g. escitalopram, fluoxetine, sertraline), serotonin-norepinephrine reuptake inhibitors (e.g. venlafaxine, duloxetine, sibutramine), TCAs (e.g. amitriptyline, clomipramine, imipramine), triptans (e.g. sumatriptan, zolmitriptan, almotriptan), amphetamine, buspirone, fentanyl, lithium, tramadol and tryptophan. Increased serum plasma concentration with potent CYP3A4 inhibitors such as HIV-protease inhibitors (e.g. ritonavir), azole antifungals (e.g. itraconazole, ketoconazole), erythromycin and nefazodone. Decreased serum plasma concentration with potent CYP3A4 inducers (e.g. carbamazepine, phenytoin, rifampicin). Increased serum plasma concentration when concurrently administered with cimetidine. Increased risk of QT prolongation with drugs when concurrently administered with QTc interval prolonging drugs (e.g. azithromycin, fluconazole, chloroquine). May diminish the antihypertensive effect of α2-agonist (e.g. clonidine, methyldopa). May enhance the anticoagulant effect of warfarin.
CIMS Class
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
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