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Symbyax

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Manufacturer: Eli Lilly and Company

Score: 144.0

Quick Summary

Symbyax is a combination of olanzapine and fluoxetine used for the treatment of depressive episodes associated with bipolar I disorder and treatment-resistant depression. It should be used with caution due to the risk of suicidal thoughts and behaviors, particularly in children, adolescents, and young adults. The recommended starting dose is 6 mg/25 mg once daily, with a maximum dose of 12 mg/50 mg. Special considerations are needed for patients with certain medical conditions, pregnant or nursing women, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of depressive episodes associated with bipolar I disorder
  • Treatment of treatment-resistant depression
  • Combination of olanzapine and fluoxetine

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

  • Monoamine oxidase inhibitors (MAOIs)
  • Pimozide
  • Thioridazine

Adverse Reactions

  • Suicidal thoughts and behaviors
  • Serotonin syndrome
  • Neuroleptic malignant syndrome
  • Hyperglycemia
  • Dyslipidemia
  • Weight gain

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with certain medical conditions, such as hepatic impairment or those taking other medications

Depressive episodes associated with bipolar I disorder

Adult Dose

6 mg/25 mg once daily

Pediatric Dose

3 mg/25 mg once daily (for ages 10-17 years)

Treatment-resistant depression

Adult Dose

6 mg/25 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use with caution due to potential risks to the fetus
  • Pregnancy exposure registry available

Nursing Mothers

  • Use with caution due to potential risks to the infant
  • Monitor infant for adverse reactions

Pediatric Use

  • Approved for use in patients 10-17 years of age with bipolar I disorder
  • Not established for use in patients less than 10 years of age

Geriatric Use

  • Use with caution due to potential risks of increased sedation, orthostatic hypotension, and other adverse reactions
  • Dose adjustments may be necessary

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