Sertraline


Generic Medicine Info
Administration
May be taken with or without food.
Contraindications
Concomitant use or within 14 days of discontinuation of MAOIs. Concurrent use with pimozide. Concomitant use of sertraline oral concentrate solution with disulfiram.
Special Precautions
Patients with family history of bipolar disorder, mania or hypomania, schizophrenia; previous seizure disorder or condition predisposing to seizures (e.g. brain damage, alcoholism); volume depletion, diabetes mellitus, history of bleeding disorders, angle-closure glaucoma or history of glaucoma, risk factors for QTc prolongation. Avoid abrupt withdrawal. Hepatic impairment. Children and elderly. Pregnancy and lactation. CYP2C19 ultrarapid and poor metabolisers. Patient Counselling This drug may impair mental and physical abilities, if affected, do not drive or operate machinery. Monitoring Parameters Monitor BMI (longitudinal monitoring), height, weight; serum Na in at-risk patients. Closely monitor mental status for worsening of depression, suicidal ideation or other unusual behavioural changes at the start of treatment or when doses are adjusted; signs and symptoms of serotonin syndrome and glucose fluctuations.
Adverse Reactions
Significant: Activation of hypomania or mania, seizures, CNS depression, QTc prolongation, Torsade de pointes, abnormal bleeding events including cutaneous bleeding (e.g. ecchymoses, purpura), bone fractures, mild pupillary dilation, sexual dysfunction, loss of glycaemic control, withdrawal symptoms. Cardiac disorders: Palpitations chest pain. Ear and labyrinth disorders: Tinnitus. Eye disorders: Visual disturbance. Gastrointestinal disorders: Nausea, diarrhoea, dry mouth, dyspepsia, constipation, vomiting, abdominal pain, flatulence, dysgeusia. General disorders and administration site conditions: Fatigue, malaise, asthenia, pyrexia. Investigations: Weight increased. Metabolism and nutrition disorders: Decreased or increased appetite. Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia. Nervous system disorders: Headache, dizziness, somnolence, paraesthesia, tremor, extrapyramidal symptoms (e.g. hyperkinesia, hypertonia, dystonia, teeth grinding or gait abnormalities), disturbance in attention. Psychiatric disorders: Insomnia, anxiety, agitation, depression, nervousness, nightmare, bruxism, decreased libido, depersonalisation. Reproductive system and breast disorders: Ejaculation failure, erectile dysfunction, irregular menstruation. Respiratory, thoracic and mediastinal disorders: Yawning, pharyngitis, rhinitis, upper respiratory tract infection. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis. Vascular disorders: Hot flush.
Potentially Fatal: Suicidal thoughts and behavior, serotonin syndrome or neuroleptic malignant syndrome (NMS), haemorrhage (e.g. gastrointestinal or gynaecological bleeding), anaphylactoid reaction, angioedema, Stevens-Johnson syndrome, erythema multiforme, vasculitis, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatraemia.
Drug Interactions
May increase risk of hyponatraemia with diuretics. Increased risk of QTc prolongation and/or ventricular arrhythmias with specific antipsychotics (e.g. ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol), specific antibiotics (e.g. erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class IA antiarrhythmics (e.g. quinidine, procainamide, Class III antiarrhythmics (e.g. amiodarone, sotalol) and other drugs that prolong QTc interval (e.g. pentamidine, methadone, halofantrine, mefloquine, probucol, tacrolimus). May increase serum concentration of phenytoin. May increase the exposure of CYP2D6 substrates (e.g. propafenone, flecainide). Increased exposure with CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin. May prolong neuromuscular blocking effects of mivacurium or other neuromuscular blockers.
CIMS Class
ATC Classification
N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Disclaimer: This information is independently developed by CIMS based on sertraline 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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