Fluoxetine - Fluoxetine tablet Prescribing Information
If you take fluoxetine tablets, you should not take any other medicines that contain fluoxetine hydrochloride including:
- Symbyax®
- Sarafem®
- Prozac Weekly®
Warnings and Precautions, Serotonin Syndrome (5.2) 07/2023
Warnings and Precautions (5.7) 07/2023
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)
Indication | Adult | Pediatric |
| MDD (2.1) | 20 mg/day in am (initial dose) | 10 mg/day to 20 mg/day (initial dose) |
| OCD (2.2) | 20 mg/day in am (initial dose) | 10 mg/day (initial dose) |
| Bulimia Nervosa (2.3) | 60 mg/day in am | |
| Panic Disorder (2.4) | 10 mg/day (initial dose) |
- A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.7)
Fluoxetine Tablets, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine.
- Fluoxetine Tablets, USP 10 mg are "White to Off white, film coated Oval, scored tablets debossed with "F" on the left of the score and "10" on the right of score on one side of the tablet and plain on other side.
- Fluoxetine Tablets, USP 20 mg are "White to Off white, film coated Oval, scored tablets debossed with "F" on the left of the score and "20" on the right of score on one side of the tablet and plain on other side.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Patients should be advised to notify their physician if they intend to breast-feed an infant during therapy. Because fluoxetine is excreted in human milk, nursing while taking fluoxetine is not recommended
Fluoxetine is approved for use in pediatric patients with MDD and OCD