Paroxetine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Major depressive disorder As paroxetine hydrochloride/mesilate conventional tab; oral susp: 20 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week. Max: 50 mg/day. As paroxetine hydrochloride modified-release tab: Initial: 25 mg daily, may be increased in 12.5 mg/day increments at intervals of at least 1 week. Max: 62.5 mg/day. Obsessive compulsive disorder As paroxetine hydrochloride/mesilate conventional tab; oral susp: Initial: 20 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week to 40 mg/day. Max: 60 mg/day. Panic disorder with or without agoraphobia As paroxetine hydrochloride/mesilate conventional tab; oral susp: Initial: 10 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week to 40 mg/day. Max: 60 mg/day. As paroxetine hydrochloride modified-release tab: Initial: 12.5 mg daily, may be increased in 12.5 mg/day increments at intervals of at least 1 week. Max: 75 mg/day. Social anxiety disorder As paroxetine hydrochloride conventional tab/oral susp: 20 mg daily, may be gradually increased in 10 mg increments if necessary. Max: 50 mg or 60 mg/day. As paroxetine hydrochloride modified-release tab: Initial: 12.5 mg daily, may be increased in 12.5 mg/day increments at intervals of at least 1 week. Max: 37.5 mg/day. Generalised anxiety disorder As paroxetine hydrochloride/mesilate conventional tab; oral susp: Initial: 20 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week. Max: 50 mg/day. Posttraumatic stress disorder As paroxetine hydrochloride conventional tab/oral susp: Initial: 20 mg daily, may be gradually increased in 10 mg increments at intervals of at least 1 week. Max: 50 mg/day. Premenstrual dysphoric disorder As paroxetine hydrochloride modified-release tab: Initial: 12.5 mg daily, may be increased to 25 mg/day after an interval of at least 1 week if necessary; doses may be given either continuously or intermittently. All doses are adjusted according to individual response and given as a single daily dose preferably in the morning. Moderate to severe vasomotor symptoms associated with menopause As paroxetine mesilate cap: 7.5 mg once daily preferably at bedtime.
Administration
Paroxetine: May be taken with or without food. May be taken w/ meals to minimise GI upset.
Contraindications
Pregnancy (as paroxetine mesilate cap). Concurrent use with or within 14 days after discontinuation of MAOIs (including linezolid and IV methylene blue). Concomitant use with pimozide, thioridazine.
Special Precautions
Patients with history of suicide-related events or pre-existing suicidal ideation, bipolar disorder, history of mania, pre-existing seizure disorder or conditions predisposing to seizures (e.g. brain damage, alcoholism), narrow-angle glaucoma or history of glaucoma, CV disease (e.g. recent history of MI, unstable heart disease), history of bleeding disorders or other conditions predisposing to bleeding, diabetes mellitus, volume depletion. Paroxetine mesilate cap: Not indicated for the treatment of any psychiatric conditions. Oral susp: Patients with high gastric pH or achlorhydria. Concomitant electroconvulsive therapy. Avoid abrupt withdrawal. Severe renal (CrCl <30 mL/min) and hepatic impairment. Debilitated patients. Elderly. Pregnancy and lactation. CYP2D6 ultrarapid and poor metabolisers. Patient Counselling This drug may impair judgment, thinking or motor skills, if affected, do not drive or operate machinery. Monitoring Parameters Perform pregnancy tests for female patients prior to treatment initiation. Monitor renal function at baseline and as clinically indicated; LFTs, CBC as clinically indicated; serum Na in at-risk patients. Closely monitor for signs and symptoms of serotonin syndrome, clinical worsening, suicidality, or unusual behavioural changes especially at the start of therapy or during dose adjustments.
Adverse Reactions
Significant: Suicidal thoughts and behaviour, worsening of depression, mania or hypomania, akathisia or psychomotor restlessness, seizures, bleeding abnormalities (e.g. ecchymoses, purpura, epistaxis, haematomas, petechiae), anticholinergic effects, bone fractures, mild pupillary dilation, sexual dysfunction (e.g. impotence, ejaculatory disorder), withdrawal symptoms. Rarely, hyponatraemia (primarily in elders). Cardiac disorders: Sinus tachycardia. Rarely, bradycardia. Ear and labyrinth disorders: Tinnitus. Eye disorders: Blurred vision. Gastrointestinal disorders: Nausea, constipation, dry mouth, vomiting, diarrhoea. General disorders and administration site conditions: Asthenia, fatigue, malaise, lethargy. Investigations: Weight gain, increased cholesterol levels, transient changes in blood pressure. Rarely, elevated hepatic enzymes. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Rarely, myalgia, arthralgia. Nervous system disorders: Headache, dizziness, tremor, impaired concentration. Psychiatric disorders: Insomnia, somnolence, agitation, abnormal dreams, aggression. Renal and urinary disorders: Urinary retention or incontinence. Respiratory, thoracic and mediastinal disorders: Yawning. Skin and subcutaneous tissue disorders: Sweating, rashes, pruritus. Vascular disorders: Postural hypotension.
Potentially Fatal: Serotonin syndrome, neuroleptic malignant syndrome (NMS)-like events, haemorrhage (e.g. gastrointestinal or gynaecological haemorrhage). Rarely, anaphylactoid reactions and angioedema.
Drug Interactions
Increased risk of bleeding with aspirin, NSAIDs including COX-2 inhibitors, oral anticoagulants (e.g. warfarin), atypical antipsychotics (e.g. clozapine). May increase risk of hyponatraemia with diuretics. May increase blood glucose levels with pravastatin. May reduce plasma concentration and efficacy of endoxifen (active metabolite of tamoxifen). May reduce absorption of paroxetine oral susp with antacids, histamine H2-receptor antagonists, PPIs. Decreased plasma levels with fosamprenavir/ritonavir. Increased plasma levels of procyclidine, certain TCAs (e.g. clomipramine, nortriptyline, desipramine), phenothiazines (e.g. perphenazine), risperidone, atomoxetine, certain class 1C antiarrhythmics (e.g. propafenone, flecainide), metoprolol. May increase plasma concentrations with cimetidine.
ATC Classification
N06AB05 - paroxetine ; 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 paroxetine 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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