Compare To: Prozac? Pulvules? and Sarafem?
PROZAC?
(fluoxetine hydrochloride) Pulvule? for Oral Use
PROZAC
(fluoxetine hydrochloride) Oral Solution
PROZAC Weekly?
(fluoxetine hydrochloride) Delayed-Release Capsules for Oral Use
DESCRIPTION
PROZAC? (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem?, fluoxetine hydrochloride). It is designated (?)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO?HCl. Its molecular weight is 345.79.
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Each Pulvule? contains fluoxetine hydrochloride equivalent to 10 mg (32.3 ?mol), 20 mg (64.7 ?mol), or 40 mg (129.3 ?mol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10-and 20 mg Pulvules also contain FD&C Blue No. 1, and the 40 mg Pulvule also contains FD&C Blue No. 1 and FD&C Yellow No. 6.
The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 ?mol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.
PROZAC Weekly? capsules, a delayed-release formulation, contain enteric-coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 ?mol) of fluoxetine. The capsules also contain D&C Yellow No. 10, FD&C Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients.
INDICATIONS
Major Depressive Disorder
PROZAC? is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re evaluated [see DOSAGE AND ADMINISTRATION].
Obsessive Compulsive Disorder
PROZAC is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies].
The effectiveness of PROZAC in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use PROZAC for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION].
Bulimia Nervosa
PROZAC is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies].
The physician who elects to use PROZAC for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION].
Panic Disorder
PROZAC is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies].
The effectiveness of PROZAC in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use PROZAC for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION].
PROZAC and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax? .
PROZAC and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients.
PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
PROZAC and Olanzapine in Combination: Treatment Resistant Depression
When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
PROZAC and olanzapine in combination is indicated for the acute treatment of treatment resistant depression (Major Depressive Disorder in adult patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
PROZAC monotherapy is not indicated for the treatment of treatment resistant depression.
