Mirtazapine


Full Prescribing Info
Dosage/Direction for Use

Oral
Depression
Adult: Initially, 15 mg daily; may be increased gradually depending on clinical response. Change dose at intervals of at least 1-2 wk. Usual effective dose: 15-45 mg daily given as single dose, preferably at bedtime, or in 2 divided doses.
Administration
May be taken with or without food.
Special Precautions
Epilepsy or history of seizures; avoid completely in unstable cases. Hepatic or renal impairment, cardiac disorders e.g. conduction disturbances, angina pectoris, recent MI. Hypotension, DM, psychoses, history of bipolar disorder. Stop treatment if jaundice develops. Micturition disturbances, angle-closure glaucoma, raised intraocular pressure. Monitor patient for signs of bone marrow depression. Monitor patient for suicidal tendency. Avoid abrupt withdrawal. May impair ability to drive or operate machinery. Pregnancy and lactation. Elderly.
Adverse Reactions
Increase in appetite and wt, oedema; drowsiness or sedation; dizziness, headache, increased liver enzyme levels; jaundice. Orthostatic hypotension, rash, nightmares, agitation, mania, hallucinations, paraesthesia, convulsions, tremor, myoclonus, akathisia, restless legs syndrome, arthralgia, myalgia, reversible agranulocytosis, leucopenia, granulocytopenia, hyponatraemia.
Overdosage
Symptoms: Disorientation, drowsiness, impaired memory, tachycardia. Management: Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac functions. General supportive and symptomatic measures are also recommended. Do not induce emesis. Gastric lavage may be used if done soon after ingestion, or in symptomatic patients. Administer activated charcoal. No specific antidotes are known.
Drug Interactions
Potentiation of sedative effects with alcohol or benzodiazepines. Increased plasma levels with potent CYP3A4 inhibitors (e.g. HIV-protease inhibitors, azole antifungals including ketoconazole, erythromycin, nefazodone). Reduced plasma levels with carbamazepine and other inducers of CYP3A4. Increased bioavailability with cimetidine.
Potentially Fatal: Do not use with or within 2 wk of stopping an MAOI; at least 1 wk should elapse between discontinuing mirtazapine and initiating any drug which may provoke a serious reaction (e.g. phenelzine).
Action
Mirtazapine, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic α2-receptors.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 2 hr.
Distribution: Protein-binding: 85%.
Metabolism: Hepatic by demethylation and oxidation followed by glucuronidation.
Excretion: Via urine and faeces; 20-40 hr (elimination half-life).
Storage
Oral: Store at 15-30°C. Protect from light and moisture.
CIMS Class
ATC Classification
N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.
Disclaimer: This information is independently developed by CIMS based on mirtazapine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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