Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Depression Initial: 10 mg/day, may be increased gradually to 30-150 mg/day if necessary. Maintenance dose: 30-50 mg/day. Severe cases: Doses may be increased up to Max 250 mg/day, then may be adjusted to maintenance dose of 50-100 mg/day once distinct improvement is observed. All doses may be given as a single dose at bedtime or in divided doses throughout the day. Obsessive compulsive disorder; Phobias Initial: 25 mg/day, may be increased gradually to 100-150 mg/day which should be achieved over 2 weeks according to the severity of condition. Adjunct for cataplexy associated with narcolepsy Initial: 10 mg/day, may be increased gradually to 10-75 mg/day until satisfactory response occurs. Control of cataplexy should be achieved within 24 hours of reaching the optimal dose.
Should be taken with food.
Acute recovery phase of MI, recent MI, history of QTc interval prolongation, narrow-angle glaucoma, urinary retention, mania. Severe hepatic impairment. Concomitant use with selective MAO-A inhibitors (e.g. moclobemide), linezolid, IV methylene blue; with or within 21 days of initiating or discontinuing treatment with MAOIs intended to treat psychiatric disorders.
Special Precautions
Patients with depressive disorder, bipolar disorder or other psychiatric disorders, epilepsy or conditions predisposing to seizures (e.g. brain damage, alcoholism), cerebrovascular disease, congenial long QT syndrome, history of CV disease including previous MI, stroke, tachycardia or conduction abnormalities, bleeding tendency, hyperthyroidism, hypovolaemia, hypokalaemia, tumours of adrenal medulla (e.g. phaeochromocytoma, neuroblastoma), decreased gastrointestinal motility, chronic constipation, paralytic ileus, prostatic hypertrophy, history of increased intraocular pressure or narrow-angle glaucoma, visual problems, xerostomia. Concomitant electroconvulsive therapy and elective surgery. Renal and hepatic impairment. Elderly. Pregnancy and lactation. CYP2D6 ultrarapid, intermediate, and poor metabolisers. CYP2C19 ultrarapid, rapid and poor metabolisers. Patient Counselling This drug may cause drowsiness, somnolence, or blurred vision, if affected, do not drive or operate machinery. Avoid abrupt withdrawal. Monitoring Parameters Monitor blood pressure and pulse rate prior to and during treatment; ECG, cardiac status, serum Na levels, renal function and LFTs in at-risk patients periodically during treatment and as clinically indicated. Closely monitor for signs of serotonin syndrome, and suicidal ideation or unusual behaviour changes especially during initial months of treatment or at times of dose changes.
Adverse Reactions
Significant: Suicidal ideation and behaviour, activation of psychosis and hypomanic or manic episodes, seizures, QTc prolongation, torsades de pointes, anticholinergic effects (e.g. constipation, paralytic ileus, xerostomia, blurred vision, urinary retention), CNS depression, bone fractures, dental caries, mild pupillary dilation, orthostatic hypotension, hypertensive crises, male sexual dysfunction, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatraemia, weight gain, increased ALT/AST, withdrawal or discontinuation syndrome. Rarely, bone marrow suppression, drug rash with eosinophilia and systemic syndrome (DRESS). Blood and lymphatic system disorders: Leucopenia, agranulocytosis, thrombocytopenia. Cardiac disorders: Sinus tachycardia, palpitation, ECG changes (e.g. ST and T changes). Ear and labyrinth disorders: Tinnitus. Eye disorders: Accommodation disorder. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia. General disorders and administration site conditions: Fatigue, oedema, hyperpyrexia. Investigations: Weight increased, blood sugar changes. Metabolism and nutrition disorders: Increased or decreased appetite. Musculoskeletal and connective tissue disorders: Muscle weakness, hypertonia, myalgia. Nervous system disorders: Dizziness, headache, somnolence, tremor, myoclonus, speech disorder, paraesthesia, dysgeusia, memory impairment, attention disturbance. Psychiatric disorders: Restlessness, confusional state, insomnia, delirium, aggression, anxiety, agitation, disorientation, hallucinations, nightmares. Renal and urinary disorders: Micturition disorder. Reproductive system and breast disorders: Erectile dysfunction, libido disorder, galactorrhoea, breast enlargement, orgasmic impotence in women, ejaculation failure. Respiratory, thoracic and mediastinal disorders: Yawning, pharyngitis, rhinitis, cough. Skin and subcutaneous tissue disorders: Hyperhidrosis, rash, pruritus, photosensitivity. Vascular disorders: Hot flush.
Potentially Fatal: Serotonin syndrome. Rarely, severe hepatic injury.
Drug Interactions
Increased risk of ventricular arrhythmias with pimozide, thioridazine, levacetylmethadol; adverse cardiac effects with thyroid preparations; arrhythmias or hypotension with anaesthetics; severe postural hypotension with altretamine. Increased risk of bleeding with anticoagulants, salicylic acid derivatives, NSAIDs, antirheumatic agents. May potentiate CNS depressant effects of barbiturates, benzodiazepines, opioid analgesics, general anaesthetics. May increase plasma concentrations with antipsychotics, protease inhibitors, terbinafine, cimetidine, valproate, methylphenidate, diltiazem, verapamil. Increased risk of convulsions with tramadol, phenothiazines, neuroleptics. May decrease plasma levels with rifampicin, barbiturates, carbamazepine, phenobarbital, phenytoin, nicotine, colestipol, cholestyramine. May potentiate anticholinergic effects of antiparkinsonian agents (e.g. biperiden, entacapone, selegiline), antihistamines, atropine. May diminish or abolish antihypertensive effects of guanethidine, betanidine, reserpine, clonidine, methyldopa. May potentiate CV effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, phenylpropanolamine. May enhance muscle relaxant effect of baclofen.
CIMS Class
ATC Classification
N06AA04 - clomipramine ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
Disclaimer: This information is independently developed by CIMS based on clomipramine 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
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