Fluoxetine Hcl

• Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older

  [see Warnings and Precautions (5.1)]

  .
• In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behavior. Advise families and caregivers of the need for close observation and communication with the prescriber

  [see Warnings and Precautions (5.1)]

  .
• Fluoxetine is not approved for use in children less than 7 years of age

  [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]

  .

Warnings and Precautions (5.2, 5.7)                    8/2023                           

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
  [see Clinical Studies (14.1)].
• 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
  [see Clinical Studies (14.2)].
• 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
  [see Clinical Studies (14.3)].
• Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine tablets in Panic Disorder was demonstrated in two 12-week trials in adults
  [see Clinical Studies (14.4)]
  .

This product is only available in a 60 mg dosage form. A 30 mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below.

Fluoxetine tablets, USP, are available as 60 mg (fluoxetine base equivalent), white to off white, film coated, capsule shaped, functional-scored tablets debossed with "F" on the left of the score and "60" on the right of the score on one side and score line on other side.

• Pregnancy
  : SSRI use, particularly later in pregnancy, may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate (8.1)
• Pediatric Use
  : Safety and effectiveness of fluoxetine in patients < 8 years of age with MDD and < 7 years of age with OCD have not been established (8.4)