Symbyax Dosage
Generic name: olanzapine and fluoxetine hydrochloride
Dosage form: capsule
This dosage information does not include all the information needed to use Symbyax safely and effectively. See full prescribing information for Symbyax.
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Depressive Episodes Associated with Bipolar I Disorder
SYMBYAX should be administered once daily in the evening, generally beginning with the 6 mg/25 mg capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of SYMBYAX has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy was demonstrated with SYMBYAX in a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg [see Clinical Studies (14.1)]. The safety of doses above 18 mg per 75 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 SYMBYAX 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.
Treatment Resistant Depression
SYMBYAX should be administered once daily in the evening, generally beginning with the 6 mg/25 mg capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of SYMBYAX has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy was demonstrated with SYMBYAX in a dose range of olanzapine 6 to 18 mg and fluoxetine 25 to 50 mg [see Clinical Studies (14.2)]. The safety of doses above 18 mg per 75 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 SYMBYAX 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.
Specific Populations
The starting dose of SYMBYAX 3 mg/25 mg to 6 mg/25 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of SYMBYAX (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. SYMBYAX has not been systematically studied in patients >65 years of age or in patients <18 years of age [see Warnings and Precautions (5.19), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3, 12.4)].
​Treatment of Pregnant Women During the Third Trimester — When treating pregnant women with fluoxetine, a component of SYMBYAX, during the third trimester, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding. The physician may consider tapering the dose of fluoxetine in the third trimester [see Use in Specific Populations (8.1)].
Discontinuation of Treatment with SYMBYAX
Symptoms associated with discontinuation of fluoxetine, a component of SYMBYAX, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.23)].
