Fluoxetine 10 MG Oral Tablet
1 INDICATIONS AND USAGE Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years ( 1.1 ) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years ( 1.2 ) Acute and maintenance treatment of Bulimia Nervosa in adult patients ( 1.3 ) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients ( 1.4 ). 1.1 Major Depressive Disorder Fluoxetine 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 ( 14.1 )] . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration ( 2.1 )] . 1.2 Obsessive Compulsive Disorder Fluoxetine 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 ( 14.2 )] . The effectiveness of fluoxetine 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 fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration ( 2.2 )] . 1.3 Bulimia Nervosa Fluoxetine 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 ( 14.3 )] . The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration ( 2.3 )] . 1.4 Panic Disorder Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies ( 14.4 )] . The effectiveness of fluoxetine 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 fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration ( 2.4 )] .
Lupin Pharmaceuticals, Inc.
OVAL WHITE L U F 55
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Lupin Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine Tablets, USP are available containing
FLUOXETINE HYDROCHLORIDE, USP equivalent to 10 mg or 20 mg of fluoxetine. The 10 mg tablets are white to off-white film-coated, oval shaped tablet, debossed with "L" on the left of the score and "U" on the right of the score on one side of the tablet and "F" on the left of the score and "55" on the right of the score on other side. They are available as follows: NDC 68180-998-06 bottles of 30 tablets NDC 68180-998-01 bottles of 100 tablets The 20 mg tablets are white to off-white film-coated, oval shaped tablet, debossed with "L" on the left of the score and "U" on the right of the score on one side of the tablet and "F" on the left of the score and "56" on the right of the score on other side. They are available as follows: NDC 68180-999-06 bottles of 30 tablets NDC 68180-999-01 bottles of 100 tablets 16.2 Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. PHARMACIST: Dispense the accompanying Medication Guide to each patient.
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