Fluoxetinedrug info
fluoxetine 60 MG Oral Tablet
What it is used for
Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine tablets in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age. Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine tablets in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults. Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine tablets in Panic Disorder was demonstrated in two 12-week trials in adults. Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major Depressive Disorder (MDD) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age Obsessive Compulsive Disorder (OCD) Adults: Efficacy was established in two 13-week trials Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age Bulimia Nervosa Adults: Efficacy was established in two 8-week trials and one 16-week trial Panic Disorder, with or without agoraphobia Adults: Efficacy was established in two 12-week trials
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 14, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N -methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17 H 18 F 3 NO
HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride, USP is a white or almost white powder, very soluble in ethanol and in chloroform, slightly soluble in acetone and practically insoluble in toluene. Each scored tablet contains fluoxetine hydrochloride, USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 14, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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