Atomoxetine


Generic Medicine Info
Administration
May be taken with or without food. Swallow whole, do not open cap.
Contraindications
Narrow-angle glaucoma, current or history of phaeochromocytoma, severe CV disorder (e.g. severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, MI, potentially fatal arrhythmias and channelopathies, known serious structural cardiac abnormalities, coronary artery disease), severe cerebrovascular disorders (e.g. cerebral aneurysm, stroke). Concomitant use with or within 14 days after discontinuing treatment with MAOIs.
Special Precautions
Patients with comorbid bipolar disorder, existing anxiety disorders, depression, and tics related to Tourette's syndrome; known or suspected long QT interval or family history of QT prolongation, underlying conditions (e.g. hypertension, tachycardia, CV or cerebrovascular disease), history of seizures, urinary retention or bladder outlet obstruction. Hepatic impairment. Children. Pregnancy and lactation. CYP2D6 ultrarapid, normal, intermediate, and poor metabolisers. Patient Counselling This drug may cause dizziness, somnolence or fatigue, if affected, do not drive or operate machinery. Capsules should not be opened as this drug is an ocular irritant. If the contents of the capsule accidentally come in contact with the eye, it must be flushed immediately with water. Hands and any potentially contaminated surface should be washed as soon as possible. Monitoring Parameters Monitor blood pressure and pulse at baseline, after increasing dose, and periodically during treatment; growth (e.g. weight, height) and appetite in children; liver enzymes upon signs or symptoms of liver dysfunction and for several weeks after treatment discontinuation; physical exam to assess cardiac disease at baseline or if symptoms of cardiac disease develop during treatment, and further work-up (e.g. ECG, echocardiogram) if exam findings suggest cardiac disease. Closely monitor for signs of suicidal ideation and behavioural changes during initial months of therapy or at times of dose changes.
Adverse Reactions
Significant: Suicide-related behaviour (e.g. suicide attempts, suicidal ideation), psychotic or manic symptoms (e.g. hallucination, delusional thinking, mania, agitation), aggressive behaviour, hostility or emotional lability, CV effects (e.g. increased blood pressure and heart rate, orthostatic hypotension), altered cardiac conduction (e.g. QT interval prolongation), seizures, urinary retention or hesitancy, priapism. Rarely, anxiety and depression or depressed mood, tics; hepatic effects (e.g. elevated hepatic enzymes and bilirubin, jaundice, severe liver injury, hepatic failure), allergic reactions (e.g. anaphylactic reactions, angioneurotic oedema, rash, urticaria). Cardiac disorders: Palpitation, tachycardia. Eye disorders: Mydriasis, blurred vision. Gastrointestinal disorders: Nausea, vomiting, dry mouth, abdominal pain, constipation, dyspepsia, flatulence. General disorders and administration site conditions: Fatigue, lethargy, asthenia. Investigations: Weight decreased. Metabolism and nutrition disorders: Decreased appetite, anorexia. Musculoskeletal and connective tissue disorders: Muscle spasm. Nervous system disorders: Headache, somnolence, dizziness, dysgeusia, paraesthesia, tremor. Psychiatric disorders: Insomnia, irritability, mood swings, sleep disorder. Renal and urinary disorders: Dysuria, pollakiuria. Reproductive system and breast disorders: Dysmenorrhoea, male genital pain, ejaculation disorder, erectile dysfunction. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Pruritus, dermatitis, hyperhidrosis. Vascular disorders: Flushing, syncope, peripheral coldness, Raynaud's phenomenon.
Potentially Fatal: Serious CV events (e.g. sudden death, stroke, MI).
Drug Interactions
Increased exposure with CYP2D6 inhibitors (e.g. fluoxetine, paroxetine, quinidine, terbinafine). May potentiate CV effects of salbutamol or other β2 agonists. Increased risk of QT interval prolongation with neuroleptics, class IA and III antiarrhythmics, TCAs, thiazide diuretics, moxifloxacin, eryhthromycin, methadone, mefloquine, lithium, cisapride. Increased risk of seizures with SSRIs, phenothiazines, butyrophenone, bupropion, tramadol. May decrease effectiveness of antihypertensive agents. May cause additive or synergistic effects with imipramine, venlafaxine, mirtazapine, pseudoephedrine, phenylephrine.
CIMS Class
Other CNS Drugs & Agents for ADHD
ATC Classification
N06BA09 - atomoxetine ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Disclaimer: This information is independently developed by CIMS based on atomoxetine 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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