May be taken with or without food.
Administration
May be taken with or without food.
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Contraindications
Unstable seizure disorder. Lactation. Concomitant admin or within 14 days of discontinuing MAOIs or fluvoxamine treatment. Concomitant use with alosetron, pimozide, thioridazine, tizanidine, cisapride, ramelteon, terfenadine, astemizole, linezolid, methylene blue IV.
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Special Precautions
Patient with bipolar disorder; history of convulsive disorder; CV disease (e.g. recent history of MI, unstable heart disease), diabetes mellitus, history of mania or hypomania, history of bleeding or other predisposing conditions (e.g. thrombocytopenia, coagulation disorders), raised intraocular pressure or at risk of acute narrow-angle glaucoma, volume depletion. Smokers. Concomitant electroconvulsive therapy. Avoid abrupt withdrawal. Renal and hepatic impairment. Children and elderly. Pregnancy. CYP2D6 poor metabolisers. Patient Counselling This drug may cause somnolence, if affected, do not drive or operate machinery. Monitoring Parameters Monitor weight and BMI; LFT at baseline and as clinically indicated. Closely monitor for clinical worsening, suicidality, changes in behaviour at treatment initiation and during dosage adjustments; anxiety, social functioning, mania, panic attacks, or other unusual behavioural changes. Monitor for signs and symptoms of serotonin syndrome and akathisia.
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Adverse Reactions
Significant: Suicidal thinking and behavior in children, adolescent and young adults, activation of mania or hypomania, seizures, akathisia or psychomotor restlessness, bleeding events (e.g. cutaneous or mucous bleeding), CNS depression, mild pupillary dilation, bone fractures, impaired glucose control (e.g. hyper- or hypoglycaemia, decreased glucose tolerance), sexual dysfunction, hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), withdrawal symptoms.
Cardiac disorders: Palpitations, tachycardia.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia.
General disorders and administration site conditions: Asthenia, malaise, ataxia.
Hepatobiliary disorders: Abnormal hepatic function.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache, dizziness, somnolence, tremor, extrapyramidal disorder, convulsion.
Psychiatric disorders: Agitation, anxiety, nervousness, insomnia, hallucination, confusion, aggression.
Renal and urinary disorders: Urinary incontinence or retention, enuresis, nocturia.
Reproductive system and breast disorders: Delayed ejaculation, galactorrhoea.
Skin and subcutaneous tissue disorders: Hyperhidrosis, sweating, photosensitivity.
Vascular disorders: Orthostatic hypotension.
Potentially Fatal: Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like events, haemorrhage (e.g. gastrointestinal or gynaecological haemorrhage). |
Drug Interactions
Increased risk of bleeding with aspirin, NSAIDs, warfarin, ticlopidine, other anticoagulants, atypical antipsychotics and phenothiazines. May increase plasma concentrations of narrow therapeutic index drugs (e.g. theophylline, tacrine, methadone, mexiletine, phenytoin, carbamazepine, ciclosporin), TCAs (e.g. amitriptyline, clomipramine, imipramine), neuroleptics (e.g. clozapine, olanzapine, quetiapine), oxidatively metabolised benzodiazepines (e.g. triazolam, midazolam, alprazolam, diazepam), ropinirole, propranolol, warfarin. Increased risk of hyponatraemia with diuretics.
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CIMS Class
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ATC Classification
N06AB08 - fluvoxamine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
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