Fluoxetine/Olanzapine Dosage
This dosage information may not include all the information needed to use Fluoxetine/Olanzapine safely and effectively. See additional information for Fluoxetine/Olanzapine.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:
Usual Geriatric Dose for:
Additional dosage information:
Usual Adult Dose for Bipolar Disorder
For Depressive Episodes Associated with Bipolar I Disorder:
Initial dose: 25 mg-6 mg orally once a day in the evening.
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine-olanzapine should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Usual Adult Dose for Depression
For Treatment Resistant Depression:
Initial dose: 25 mg-6 mg orally once a day in the evening.
While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of fluoxetine-olanzapine has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy has been demonstrated with fluoxetine-olanzapine in a dose range of 25 to 50 mg for fluoxetine and 6 to 18 mg for olanzapine. The safety of doses above 75 mg per 18 mg has not been evaluated in clinical studies.
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine-olanzapine should remain on it, it is generally accepted that 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) is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Usual Geriatric Dose for Bipolar Disorder
For Depressive Episodes Associated with Bipolar I Disorder:
Initial dose: 25 mg-3 mg to 25 mg-6 mg orally once a day in the evening.
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine-olanzapine should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Usual Geriatric Dose for Depression
For Treatment Resistant Depression:
Initial dose: 25 mg-3 mg to 25 mg-6 mg orally once a day in the evening.
While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of fluoxetine-olanzapine has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy has been demonstrated with fluoxetine-olanzapine in a dose range of 25 to 50 mg for fluoxetine and 6 to 18 mg for olanzapine. The safety of doses above 75 mg per 18 mg has not been evaluated in clinical studies.
While there is no body of evidence to answer the question of how long a patient treated with fluoxetine-olanzapine should remain on it, it is generally accepted that 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) is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
Renal Dose Adjustments
Dosing adjustment based on renal impairment alone is not routinely necessary.
Liver Dose Adjustments
In general, a starting dose of fluoxetine-olanzapine 25 mg-3 mg to 25 mg-6 mg should be used for patients with hepatic impairment.
In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, are decreased, thus increasing the elimination half-lives of these substances. A lower or less frequent dose of the fluoxetine component of fluoxetine-olanzapine should be used in patients with cirrhosis. Caution is advised when using fluoxetine-olanzapine in patients with diseases or conditions that could affect its metabolism.
Dose Adjustments
The starting dose of fluoxetine-olanzapine 25 mg-3 mg to 25 mg-6 mg should be used for patients with a predisposition to hypotensive reactions, or patients who exhibit a combination of factors that may slow the metabolism of fluoxetine-olanzapine (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients.
Precautions
Fluoxetine-olanzapine has not been systematically studied in patients 65 years of age or older.
Fluoxetine-olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia. Collective data from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although fluoxetine-olanzapine was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents.
Children and adolescents with major depressive disorder and other psychiatric disorders have been reported to be at an increased risk of suicidal thinking and suicidality with antidepressant use.
Suicide is an inherent risk in any depressed patient. Patients should be closely supervised and dispensed the smallest quantity of drug possible while receiving fluoxetine-olanzapine therapy or any other therapy for depression.
Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. The risk of suicidality appears to be greatest during the first few months of treatment, or when there is a dosage change.
Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
Fluoxetine-olanzapine is not cleared by hemodialysis. Therefore, no adjustment is recommended. There are no data on the peritoneal dialysis clearance of fluoxetine-olanzapine.
Other Comments
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for fluoxetine-olanzapine. It includes a Medication Guide. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
