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Symbyax

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Symbyax

Indications
Dosage
How Supplied

INDICATIONS

Depressive Episodes Associated with Bipolar I Disorder

SYMBYAX® is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder [see Clinical Studies].

Treatment Resistant Depression

SYMBYAX is indicated for the acute treatment of treatment resistant depression (Major Depressive Disorder in adults who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Depressive Episodes Associated with Bipolar I Disorder

Adults

SYMBYAX should be administered once daily in the evening, generally beginning with the 6 mg/25 mg (mg equivalent olanzapine/mg equivalent fluoxetine) 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 mg to 12 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies]. The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies.

Children and Adolescents (10 to 17 years of age)

SYMBYAX should be administered once daily in the evening, generally beginning with the 3 mg/25 mg capsule, without regard to meals, with a recommended target dose within the approved dosing range (6/25; 6/50; 12/25; 12/50 mg) [see Clinical Studies]. The safety of doses above 12 mg of olanzapine and 50 mg of fluoxetine has not been evaluated in pediatric clinical studies.

There is no body of evidence to answer the question of how long a patient treated with SYMBYAX should remain on it beyond 8 weeks. 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 mg to 18 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies]. The safety of doses above 18 mg/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 < 10 years of age [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

Treatment of Pregnant Women

When treating pregnant women with fluoxetine, a component of SYMBYAX, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding. [see Use in Specific Populations].

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with SYMBYAX. Conversely, at least 5 weeks should be allowed after stopping SYMBYAX before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use of SYMBYAX with Other MAOIs such as Linezolid or Methylene Blue

Do not start SYMBYAX in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving SYMBYAX therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, SYMBYAX should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with SYMBYAX may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with SYMBYAX is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

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].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules (mg equivalent olanzapine/mg equivalent fluoxetine):

  • 3 mg/25 mg
  • 6 mg/25 mg
  • 6 mg/50 mg
  • 12 mg/25 mg
  • 12 mg/50 mg

SYMBYAX capsules are supplied in 3/25-, 6/25-, 6/50-, 12/25-, and 12/50 mg (mg equivalent olanzapine/mg equivalent fluoxetinea) strengths.

SYMBYAX CAPSULE STRENGTH
3 mg/25 mg 6 mg/25 mg 6 mg/50 mg 12 mg/25 mg 12 mg/50 mg
Color Peach & Light Yellow Mustard Yellow & Light Yellow Mustard Yellow & Light Grey Red & Light Yellow Red & Light Grey
Capsule No. PU3230 PU3231 PU3233 PU3232 PU3234
Identification Lilly 3230 Lilly 3231 Lilly 3233 Lilly 3232 Lilly 3234
25-Mar 25-Jun Jun-50 25-Dec Dec-50
NDC Codes*
Bottles 30 0002-3230-30 0002-3231-30 0002-3233-30 0002-3232-30 0002-3234-30
Blisters IDb100 NA 0002-3231-33 NA NA NA
* NA indicates Not Available.
aFluoxetine base equivalent.
bIDENTI-DOSE®, Unit Dose Medication, Lilly.

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep tightly closed and protect from moisture.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA.

Last reviewed on RxList: 8/7/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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