DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Symbyax (Olanzapine / Fluoxetine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Depressive Episodes Associated with Bipolar I Disorder

SYMBYAX is indicated for the acute treatment of depressive episodes associated with BipolarI Disorder in adults [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

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 12mg and fluoxetine 25 to 50mg [see Clinical Studies ]. The safety of doses above 18mg per 75mg 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 BipolarI Disorder, including the depressive episodes associated with BipolarI 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 18mg and fluoxetine 25 to 50mg [see Clinical Studies]. The safety of doses above 18mg per 75mg 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 3mg/25mg to 6mg/25mg 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 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 using a lower dose in the third trimester [see Use in Specific Populations ].

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].

DOSAGE FORMS AND STRENGTHS

Capsules (mg equivalent olanzapine/mg equivalent fluoxetine):

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

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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

a Fluoxetine base equivalent.

b IDENTI-DOSE®, Unit Dose Medication, Lilly.

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 Mustard Yellow Mustard Yellow Red & Light Red & Light
& Light Yellow & Light Yellow & Light Grey Yellow 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 IDb100 0002-3231-33 0002-3233-33 0002-3232-33 0002-3234-33

Storage and Handling

Store at 25C(77F); excursions permitted to 15-30C(59-86F) [see USP Controlled Room Temperature].

Keep tightly closed and protect from moisture.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017