fluoxetine 60 mg Tablet, 30-count — NDC 75834-148-30 (Billing 75834-0148-30)

1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine 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 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 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 in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies ( 14.4 )].

Fluoxetine tablets are a selective serotonin reuptake inhibitor indicated (SSRI) the treatment of: Major Depressive Disorder (MDD) ( 1 ) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study ( 14.1 ) Pediatrics: Efficacy was established in two 8-to 9-week trials of patients aged 8 to 18 years ( 14.1 ) Obsessive Compulsive Disorder (OCD) ( 1 ) Adults: Efficacy was established in two 13-week trials ( 14.2 ) Pediatrics: Efficacy was established in one 13-week trial in patients aged 7 to 17 years ( 14.2 ) Bulimia Nervosa ( 1 ) Adults: Efficacy was established in two 8-week trials and one 16-week trial ( 14.3 ) Panic Disorder, with or without agoraphobia ( 1 ) Adults: Efficacy was established in two 12-week trials ( 14.4 )

2 DOSAGE AND ADMINISTRATION 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.

Use another fluoxetine product for initial doses of 10 to 20 mg/day or for doses other than 30 mg or 60 mg: Indication Adult Pediatric MDD ( 2.1 ) 20 mg/day in morning (initial dose) 20 mg/day (target dose) 80 mg/day (maximum dose studied) 10 to 20 mg/day (initial dose)* *This product has not been studied in doses greater than 20 mg/day in pediatric MDD. OCD ( 2.2 ) 20 mg/day in morning (initial dose) 20 to 60 mg/day (target dose) 10 mg/day (initial dose) 10 to 60 mg/day (target dose) Bulimia Nervosa ( 2.3 ) 60 mg/day in morning - Panic Disorder ( 2.4 ) 10 mg/day (initial dose) 20 mg/day (target dose) 60 mg/day (maximum dose studied) - No additional benefits seen at higher doses above 20 mg/day in MDD ( 2.1 , 14.1 ) Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2.5 , 8.6 )

2.1Major Depressive Disorder Initial Treatment Adult —Initiate fluoxetine 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (ie, morning and noon).

The maximum fluoxetine dose should not exceed 80 mg/day. In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in MDD in most cases [see Clinical Studies ( 14.1 )].

Pediatric (children and adolescents) —Treatment should be initiated with a dose of 10 to 20 mg/day, After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.

In the short-term (8- to 9-week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of MDD, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies ( 14.1 )]. Doses greater than 20 mg/day have not been studied in pediatric patients with MDD. This product is only available in a 60 mg dosage form.

Administration of doses with demonstrated efficacy of fluoxetine 10 mg/day to 20 mg/day in pediatric MDD requires the use of another formulation. All patients —As with other drugs effective in the treatment of MDD, the full effect may be delayed until 4 weeks of treatment or longer. Periodically reassess to determine the need for maintenance treatment.

Switching Patients to a Tricyclic Antidepressant (TCA) —Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is co-administered or has been recently discontinued [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.6 )].

2.2Obsessive Compulsive Disorder Initial Treatment Adults —Initiate fluoxetine 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer.

Doses above 20 mg/day may be administered on a once daily (ie, morning) or twice daily schedule (ie, morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.

In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, pat… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Fluoxetine tablets, USP 60 mg, are are available as 60-mg (fluoxetine base equivalent), film coated, functionally scored, capsule shaped, white to off white tablets debossed with "0 95" on one side ("0" on one side of score and "95" on other side of score) and "6 0" on other side ("6" on one side of score and "0" on other side of score). Tablets: 60 mg, functionally scored ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Information on Medication Guide and Benefits/Risks of Fluoxetine Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine tablets and to reread it each time the prescription is renewed. Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine tablets and should counsel them in its appropriate use.

Healthcare providers should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking fluoxetine tablets.

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.

Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ]. Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of fluoxetine and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, buspirone, tryptophan, amphetamines, and St.

John's Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Contraindications ( 4.1 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7.3 )]. Allergic Reactions and Rash Patients should be advised to notify their physician if they develop a rash or hives [see Warnings and Precautions ( 5.3 )] .

Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding Inform Patients about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.4 )] .

Advise patients to call their doctor if they experience any increased or unusual bruising or bleeding while taking fluoxetine. Angle-closure Glaucoma Patients should be advised that taking fluoxetine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure… [Excerpted — this section continues on DailyMed.]

MEDICATION GUIDE FLUOXETINE (floo-OX-e-teen) TABLETS USP Read the Medication Guide that comes with fluoxetine before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about fluoxetine? Fluoxetine and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: Fluoxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed . Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Pay particular attention to such changes when fluoxetine is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.

Fluoxetine may be associated with these serious side effects: 2. Serotonin Syndrome. This condition can be life-threatening and may include: agitation, hallucinations, coma or other changes in mental status coordination problems or muscle twitching (overactive reflexes) racing heartbeat, high or low blood pressure sweating or fever nausea, vomiting, or diarrhea muscle rigidity dizziness flushing tremor seizures 3.

Severe allergic reactions: trouble breathing swelling of the face, tongue, eyes or mouth rash, itchy welts (hives) or blisters, alone or with fever or joint pain 4. Abnormal bleeding: Fluoxetine and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 5.

Visual problems eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 6.

Seizures or convulsions 7. Manic episodes: greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual 8. Changes in appetite or weight.

Children and adolescents should have height and weight monitored during treatment. 9. Low salt (sodium) levels in the blood.

Elderly people may be at greater risk for this. Symptoms may include: headache weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems 10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes).

This condition can be life threatening. The symptoms may include: fast, slow, or irregular heartbeat shortness of breath dizziness or fainting Do not stop fluoxetine without first talking to your healthcare provider. Stopping fluoxetine too qui… [Excerpted — this section continues on DailyMed.]