Symbyax (Olanzapine / Fluoxetine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

SYMBYAX is indicated for the treatment of depressive episodes associated with bipolar disorder. The efficacy of SYMBYAX was established in 2 identically designed, 8–week, randomized, double–blind clinical studies.

Unlike with unipolar depression, there are no established guidelines for the length of time patients with bipolar disorder experiencing a major depressive episode should be treated with agents containing antidepressant drugs.

The effectiveness of SYMBYAX for maintaining antidepressant response in this patient population beyond 8 weeks has not been established in controlled clinical studies. Physicians who elect to use SYMBYAX for extended periods should periodically reevaluate the benefits and long–term risks of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

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).

The safety of doses above 18 mg/75 mg has not been evaluated in clinical studies.

Special Populations

The starting dose of SYMBYAX 3 mg/25 mg – 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. When indicated, dose escalation should be performed with caution in these patients. SYMBYAX has not been systematically studied in patients over 65 years of age or in patients <18 years of age (see WARNINGS, Orthostatic Hypotension, PRECAUTIONS, Pediatric Use, and Geriatric Use, and CLINICAL PHARMACOLOGY, Pharmacokinetics).

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to fluoxetine, a component of SYMBYAX, and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with fluoxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluoxetine in the third trimester.

Discontinuation of Treatment with SYMBYAX

Symptoms associated with discontinuation of fluoxetine, a component of SYMBYAX, and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.

HOW SUPPLIED

SYMBYAX capsules are supplied in 3/25–, 6/25–, 6/50–, 12/25–, and 12/50–mg (mg equivalent olanzapine/mg equivalent fluoxetine [Fluoxetine base equivalent.] ) 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
	3/25	6/25	6/50	12/25	12/50
NDC Codes
Bottles 30	0002-3230-30	0002-3231-30	0002-3233-30	0002-3232-30	0002-3234-30
Bottles 100		0002-3231-02	0002-3233-02	0002-3232-02	0002-3234-02
Bottles 1000		0002-3231-04	0002-3233-04	0002-3232-04	0002-3234-04
Blisters ID 1 100		0002-3231-33	0002-3233-33	0002-3232-33	0002-3234-33