Generic Medicine Info
Indications and Dosage
Adult: Initially, 25 mg tid, increased at 4-day interval if necessary. Max: 100 mg tid.
Elderly: Initially, 25 mg bid, increased gradually. Max: 75 mg bid.
Renal Impairment
Initially, 25 mg bid, increased gradually. Max: 75 mg bid.
Hepatic Impairment
Initially, 25 mg bid, increased gradually. Max: 75 mg bid.
May be taken with or without food.
Severe CNS depression. Personal or family history of epilepsy. Acute gout, history of nephrolithiasis. Patients with preexisting QT prolongation. Treatment of behaviour problems in elderly with dementia. Lactation.
Special Precautions
Hepatic and renal impairment, elderly. Angina pectoris due to coronary artery disease, CV diseases e.g. severe hypertension, history of gout or hyperuricaemia, benign prostatic hyperplasia, urinary retention, angle-closure glaucoma, paralytic ileus, Parkinson's disease, tumours of the adrenal medulla e.g. phaeochromocytoma or neuroblastoma. May impair ability to drive or operate machinery. Avoid abrupt withdrawal. Monitor ECG in patients at risk of developing arrhythmias before starting treatment. Correct any electrolytes imbalance before treatment commencement and continue ECG and electrolytes monitoring during treatment, especially at each dose increase. Wkly monitoring of liver function for at least the 1st 3 mth of therapy in hepatic impairment. Pregnancy.
Adverse Reactions
Headache, asthenia, hypotension, tachycardia, elevated LFT, increased prolactin levels, wt gain, constipation, agitation, anxiety, dizziness, insomnia, somnolence, sweating, blurring of vision. Extrapyramidal symptoms and tardive dyskinesia with prolonged treatment. GI disturbances, blood dyscrasias, photosensitisation.
Potentially Fatal: Neuroleptic malignant syndrome.
Drug Interactions
Increased risk of arrhythmias with drugs that prolong QT interval or cause hypokalaemia. Increased zotepine concentration with fluoxetine, diazepam. Increased CNS depresssion with alcohol, CNS depressants. Additive antimuscarinic effects with antimuscarinics. Additive hypotensive effects with antihypertensives and some anaesthetic drugs.
Potentially Fatal: Increased risk of seizures with high dose of antipsychotic drugs.
Description: Zotepine is an atypical antipsychotic that is an antagonist at central dopamine (D1 and D2) receptors. It also binds to serotonin, adrenergic (α1), and histamine (H1) receptors, and inhibits noradrenaline reuptake.
Absorption: Well absorbed from GI tract. Peak plasma concentrations: 2-3 hr.
Distribution: Protein-binding of zotepine and norzotepine: 97%. Distributed into breast milk.
Metabolism: Extensive first-pass metabolism to equipotent metabolite norzotepine and inactive metabolites. Mainly metabolised by CYP1A2 and CYP3A4.
Excretion: Excreted mainly in urine and faeces as inactive metabolites. Elimination half-life: 14 hr.
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Zotepine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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