RiteMED Fluoxetine

RiteMED Fluoxetine

fluoxetine

Manufacturer:

Medochemie

Distributor:

RiteMED
Concise Prescribing Info
Contents
Fluoxetine
Indications/Uses
Management of generalized anxiety disorder, obsessive-compulsive disorder, panic disorders w/ or w/o agoraphobia, social phobia & PTSD. Management of bulimia nervosa for reduction of associated binge-eating & purging activity, as a complement of psychotherapy. Treatment of pre-menstrual dysphoric disorder. Childn & adolescents ≥8 yr: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Dosage/Direction for Use
Major depressive episodes Initially 20 mg once daily, administer in the morning, may be gradually increased up to max 80 mg daily (60 mg in the elderly) if no clinical response after several wk. Doses >20 mg daily may be given in 2 divided doses (eg, in the morning & at noon) or as once daily dose. Depression Childn ≥8 yr Initially 10 mg, increased to 20 mg daily after 1 wk (except in low wt childn when such increases should not be made for several wk, & then only if the clinical response is insufficient). Bulimia nervosa 60 mg once daily. Obsessive-compulsive disorder Initially 20 mg once daily, increased after several wk if there is no response to up to 60 mg daily. Up to 80 mg has been used, sometimes divided into 2 doses. Childn ≥7 yr Initially 10 mg daily. Low-wt childn Increased after several wk to 20-30 mg daily, if required. Adolescent & heavier childn May be increased to 20 mg daily after 2 wk; may be further increased to 60 mg daily after several wk, as necessary. Panic disorder Initially 10 mg once daily. After a wk, increased to 20 mg daily; may be further increased to 60 mg daily after several wk if no improvement. Pre-menstrual dysphoric disorder 20 mg daily. Intermittent dosing: For each new cycle, start 14 days before onset of menstruation & continue until 1st full day of menstruation. Treatment may be continued for 6 mth then re-assess benefits before continuing further. Elderly Lower or less frequent dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ DM; GI disorders; glaucoma; mania; patients undergoing surgery.
Special Precautions
Discontinue treatment if seizures develop or when there is increase in seizure frequency. Discontinue treatment in patients who develop rash. Avoid use if epilepsy is poorly controlled. Caution in patients w/ epilepsy or history thereof; cardiac disease or history of bleeding disorders; impaired hepatic functions; patients receiving electroconvulsive therapy. Suicidal thoughts & behavior may develop during early treatment; closely monitor patients during early therapy until significant improvement in depression is observed. Mania may be precipitated if given for depressive component of bipolar disorder. May worsen symptoms during initial treatment of panic disorder. SSRIs should generally be w/drawn gradually to reduce risk of w/drawal symptoms. Impairment of performance (eg, ability to drive & use machines) is largely related to sedative & antimuscarinic effects. Incidence of minor fetal abnormalities in infants exposed to treatment during 1st trimester. More perinatal complications in infants exposed to fluoxetine during 3rd trimester eg, prematurity, low full-term birth wt & length, & poor neonatal adaptation. Avoid use during lactation.
Adverse Reactions
Dry mouth & GI disturbances eg, nausea, vomiting, dyspepsia, constipation & diarrhea; anorexia & wt loss; anxiety, restlessness, nervousness & insomnia, or drowsiness & fatigue; headache, tremor, dizziness, seizures, hallucinations, confusion, agitation, extrapyramidal effects, depersonalization, mania, panic attacks, sexual dysfunction, & symptoms suggestive of serotonin syndrome; excessive sweating, pruritus, skin rashes, alopecia, photosensitivity & urticaria; angioedema & anaphylactoid reactions; systemic hypersensitivity reactions involving lungs, kidneys, or liver & possibly related to vasculitis; hyponatraemia possibly due to inappropriate secretion of antidiuretic hormone (elderly); hyperprolactinaemia & galactorrhea; changes in blood sugar; arthralgia & myalgia; cases of orthostatic hypotension, yawning, urinary retention, & abnormal vision including blurred vision & mydriasis. Abnormalities in platelet aggregation (severely underwt patient), purpura & bruising, thrombocytopenia; gynecomastia unrelated to prolactin conc; symptoms of glaucoma; upper GI bleeding; hair loss; acute hepatitis; increased risk of suicidal ideation; development of atypical cutaneous lymphoid hyperplasia, bullous pemphigoid; generalized seizures in patients w/ no history of seizures; orofacial dystonias (teeth clenching) or dyskinesias (teeth grinding).
Drug Interactions
Reports of rapid development of delirium w/ clarithromycin (CYP450 inhibitor). Reports of serotonin syndrome w/ MAOIs; linezolid; carbamazepine; ritonavir, efavirenz; tramadol; pethidine. May increase anticoagulant activity of some anticoagulants including acenocoumarol & warfarin. Enhanced adverse reactions or interactions w/ combination therapy w/ different classes of antidepressants. May antagonize antiepileptics activity by lowering convulsive threshold. Re-emergence of previously controlled depressive symptoms or bulimia nervosa w/ cyproheptadine. May increase plasma conc of astemizole or terfenadine. Increased plasma conc w/ HIV PIs eg, ritonavir. Increased plasma conc of some benzodiazepines. Serious adverse effects w/ selegiline (irreversible selective inhibitor of MAO-B). Potentially fatal serotonin syndromes w/ non-selective MAOIs. Acute dystonia w/ metoclopramide. Visual hallucinations w/ zolpidem. Report of QT prolongation w/ cyclobenzaprine. Increased risk of upper GI bleeding w/ NSAIDs. Synergistic serotonergic actions w/ sibutramine.
MIMS Class
Antidepressants
ATC Classification
N06AB03 - fluoxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
RiteMED Fluoxetine cap 20 mg
Packing/Price
30's (P28/cap)