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Faverin

Faverin

fluvoxamine

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Fluvoxamine maleate
Indications/Uses
Major depressive episode & obsessive compulsive disorder (OCD).
Dosage/Direction for Use
Depression Initially 50 or 100 mg as a single dose in the evening. May gradually increase until an effective dose is reached. Effective dose: Usually 100 mg daily, adjusted according to individual's response. Dosages >150 mg should be given in divided doses. Max: 300 mg daily. Continue treatment for at least 6 mth after recovery from depressive episode. Prevention of recurrence of depression 100 mg as single daily dose. OCD Adult Initially 50 mg daily for 3-4 days. May gradually increase until effective dosage is reached. Effective dose: Usually 100-300 mg daily. Max: 300 mg daily. If total daily dose is >150 mg, administer in 2 or 3 divided doses. Adolescent & childn from 8 yr Initially 25 mg daily at bedtime, increase every 4-7 days in 25 mg increments as tolerated until an effective dose is achieved. Effective dose: Usually 50-200 mg daily. Max: 200 mg daily. If total daily dose is >50 mg, administer in 2 divided doses. If the 2 divided doses are not equal, the larger dose should be given at bedtime.
Administration
May be taken with or without food: Swallow w/ water, do not chew.
Contraindications
Hypersensitivity. Combination w/ tizanidine & MAOIs; pimozide & ramelteon. Initiate 2 wk after discontinuation of irreversible MAOI or following day after discontinuation of reversible MAOI (eg, moclobemide, linezolid). Discontinue at least 1 wk before initiating therapy w/ any MAOI.
Special Precautions
Suicide/suicidal thoughts or clinical worsening; closely monitor patients until improvement occurs. Patients w/ history of suicide-related events & those exhibiting a significant degree of suicidal ideation prior to treatment. Risk of akathisia/psychomotor restlessness. History of convulsive disorders; avoid in patients w/ unstable epilepsy; carefully monitor patients w/ controlled epilepsy; discontinue if seizures occur or if seizure frequency increases. May develop serotonin syndrome or NMS-like events particularly when given in combination w/ other serotonergic &/or neuroleptic drugs; w/ buprenorphine or buprenorphine/naloxone. May disturb glycaemic control (eg, hyperglycaemia, hypoglycaemia, decreased glucose tolerance); may need to adjust anti-diabetic dosage in patients w/ known history of DM. Patients w/ raised IOP or those at risk of acute narrow-angle glaucoma. Patients taking SSRIs, particularly in elderly & those who concomitantly use drugs known to affect platelet function or drugs that increase risk of bleeding as well as in those w/ history of bleeding disorders & in those w/ predisposing conditions (eg, thrombocytopenia or coagulation disorders). May increase risk of postpartum haemorrhage w/ SSRIs. Increased risk of QT prolongation/Torsade de Pointes when combined w/ terfenadine, astemizole or cisapride. Electroconvulsive therapy. Possible w/drawal reactions may occur when stopping therapy. History of mania/hypomania; discontinue use in any patient entering manic phase. May cause symptoms of sexual dysfunction. Possible somnolence during treatment. Start on low dose & carefully monitor patients suffering from hepatic or renal insufficiency. Pregnancy. Not to be used by women who breast-feed. Do not use in childn & adolescents <18 yr except for patients w/ OCD. Young adults 18-24 yr. Elderly.
Adverse Reactions
Anorexia; agitation, nervousness, anxiety, insomnia, somnolence, tremor, headache, dizziness; palpitations/tachycardia; abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, nausea, vomiting; hyperhidrosis; asthenia, malaise.
Drug Interactions
Risk of serotonin syndrome when used in combination w/ MAOIs including linezolid. May inhibit metabolism of CYP450 drugs. Increased AUC & Cmax of ramelteon. Co-administration w/ drugs w/ narrow therapeutic index (eg, tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine & cyclosporine). Concomitant use w/ pimozide is contraindicated due to its narrow therapeutic index & known ability to prolong QT interval. May increase plasma levels of TCAs (eg, clomipramine, imipramine, amitriptyline) & neuroleptics (eg, clozapine, olanzapine, quetiapine); benzodiazepines (eg, triazolam, midazolam, alprazolam & diazepam); caffeine. May increase plasma conc of ropinirol, propranolol & warfarin. Isolated cases of cardiac toxicity w/ thioridazine. Increased risk of QT prolongation/Torsade de Pointes w/ terfenadine, astemizole, cisapride. Sildenafil. May enhance serotonergic effects when used in combination w/ other serotonergic agents (including triptans, tramadol, buprenorphine, buprenorphine/naloxone, SSRIs & St. John's wort prep); lithium. May increase risk of haemorrhage w/ oral anticoagulants. Avoid alcohol.
MIMS Class
Antidepressants
ATC Classification
N06AB08 - fluvoxamine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Faverin FC tab 100 mg
Packing/Price
30's
Form
Faverin FC tab 50 mg
Packing/Price
60's
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