May be taken with or without food.
Administration
May be taken with or without food.
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Contraindications
Recent MI, any degree of heart block or cardiac rhythm disorders. Severe hepatic impairment. Children <6 years. Concomitant use with MAOIs or within 14 days of discontinuing non-selective, irreversible MAOIs. Concomitant use with cisapride.
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Special Precautions
Patient with CV disease (e.g. stroke, significant bradycardia, uncompensated heart failure, tachycardia, conduction abnormalities), electrolyte disturbances (e.g. hypokalaemia, hyperkalaemia, hypomagnesaemia); history of suicide-related events or exhibiting a significant degree of suicidal ideation; bipolar disorder, seizure disorder or at risk of seizures (e.g. history of seizures, head trauma, brain damage, alcoholism), diabetes mellitus, myasthenia gravis, narrow-angle glaucoma, increased IOP, urinary retention, prostatic hypertrophy, paranoid symptomatology, pyloric stenosis, paralytic ileus, hyperthyroidism, phaeochromocytoma. Concomitant electroconvulsive therapy. Patients undergoing surgery; discontinue treatment before surgery if possible. CYP2C19 ultrarapid, rapid, and poor metabolisers. CYP2D6 ultrarapid, intermediate, and poor metabolisers. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, dizziness, and impairment in general attention and concentration; if affected, do not drive or operate machinery. Monitoring Parameters Screen patients for family history of bipolar disorder, suicide, and depression before treatment. Closely monitor for clinical worsening, suicidal behaviour or thoughts, and unusual changes in behaviour. Obtain blood glucose, heart rate, blood pressure, weight, BMI, ECG (in elderly and patients with pre-existing cardiac disease), and electrolyte levels (as indicated). When used for nocturnal enuresis: Perform ECG before initiating treatment to exclude long QT syndrome.
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Adverse Reactions
Significant: Suicidal thoughts and behaviour (particularly in children and young adults); may precipitate mania or hypomania (particularly in patients with known manic-depressive illness), may aggravate psychotic symptoms (in schizophrenic patients); cardiac arrhythmias, QT interval prolongation, AV conduction disturbance; withdrawal symptoms (upon abrupt discontinuation after chronic treatment), bone fractures, hyponatraemia, acute angle-closure glaucoma, orthostatic hypotension.
Cardiac disorders: Tachycardia, palpitations.
Eye disorders: Accommodation disorder, mydriasis.
Gastrointestinal disorders: Nausea, constipation, dry mouth, dysgeusia.
General disorders and administration site conditions: Fatigue, feeling thirsty.
Investigations: Increased weight, abnormal ECG (most commonly prolonged QRS complex).
Nervous system disorders: Headache, dizziness, somnolence, tremor, speech disorder (dysarthria), paraesthesia, ataxia, disturbance in attention.
Psychiatric disorders: Aggression, agitation, confusional state.
Renal and urinary disorders: Micturition disorders.
Reproductive system and breast disorders: Decreased libido, erectile dysfunction.
Respiratory, thoracic and mediastinal disorders: Congested nose.
Skin and subcutaneous tissue disorders: Hyperhidrosis.
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Drug Interactions
May increase the risk of serotonin syndrome with opioids (e.g. buprenorphine, tramadol). May increase the risk of arrhythmias and hypotension with anaesthetics. Concomitant use with anticholinergics or neuroleptics, particularly in hot weather, may cause hyperpyrexia. May potentiate the CV effects of sympathomimetic agents (e.g. epinephrine, ephedrine, isoprenaline, norepinephrine, phenylephrine, phenylpropanolamine). May enhance the sedative effects of barbiturates and other CNS depressants. May reduce the antihypertensive effects of adrenergic neurone blockers (e.g. guanethidine, betanidine, reserpine, clonidine, methyldopa). May increase the risk of ventricular arrhythmias with antiarrhythmics (e.g. quinidine, amiodarone), certain antihistamines (e.g. astemizole, terfenadine), certain antipsychotics (e.g. pimozide, sertindole, thioridazine), halofantrine, and sotalol. Potential additive effects on QT interval and increased risk of serious CV effects when used with methadone. Concomitant use with diuretics (e.g. furosemide) may increase the risk of hypokalaemia. May increase serum concentrations with fluconazole, fluvoxamine, Na valproate, valpromide, topiramate, CYP2D6 inhibitors (e.g. duloxetine, terbinafine, bupropion, fluoxetine, paroxetine, quinidine), and other CYP450 inhibitors (e.g. cimetidine, diltiazem, verapamil). May reduce plasma concentrations with CYP450 inducers (e.g. oral contraceptives, rifampicin, phenytoin, barbiturates, carbamazepine). Risk of delirium with disulfiram. Increased anticholinergic adverse effects with nefopam. May increase the risk of bleeding with antiplatelets and anticoagulants. May increase the risk of bone fractures with SSRIs.
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CIMS Class
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ATC Classification
N06AA09 - amitriptyline ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
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