Symbyax Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Symbyax Indications
Indications
Acute depressive episodes in bipolar I disorder. Treatment-resistant depression (TRD).
Symbyax Dosage and Administration
Adult
Children
Administration
Nursing Considerations
Symbyax Contraindications
Contraindications
Symbyax Boxed Warnings
Boxed Warning
Symbyax Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Monitor for serotonin syndrome or neuroleptic malignant syndrome-like signs/symptoms; discontinue if occurs. Discontinue if Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected. Congenital or history of long QT syndrome and other conditions (eg, hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, bradyarrhythmias, other significant arrhythmias); monitor ECG periodically. Hepatic impairment. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Cardio- or cerebrovascular disease. Hypovolemia. Dehydration. History of seizures or mania/hypomania. Tardive dyskinesia. Conditions that affect metabolism or hemodynamic response. Diabetes. Monitor for hyperglycemia, hyperlipidemia; do fasting blood glucose and lipids testing at beginning, and during therapy. Monitor for weight gain. Risk for bleeding events. Angle-closure glaucoma. Urinary retention. Significant prostatic hypertrophy. Constipation. History of paralytic ileus or related conditions. Breast cancer. Perform fall risk assessments when initiating and recurrently on long-term therapy. Hyponatremia (esp. in elderly). Hyperprolactinemia. Exposure to extreme heat. Dysphagia. Sexual dysfunction. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Hepatic impairment. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to SSRIs or SNRIs exposure during 3rd-trimester pregnancy). Labor & delivery. Pregnancy. Nursing mothers: not recommended.
Symbyax Pharmacokinetics
Absorption
Peak plasma concentrations occur at approximately 4 (olanzapine) and 6 (fluoxetine) hours.
Distribution
Volume of distribution: ~1000 L (olanzapine). Plasma protein bound: 93% (olanzapine); ~94.5% (fluoxetine).
Elimination
Olanzapine: renal (57%), fecal (30%). Fluoxetine: renal. Half-life: 21–54 hours (olanzapine); 1–3 days after acute administration, and 4–6 days after chronic administration (fluoxetine).
Symbyax Interactions
Interactions
See Contraindications. Do not start with concomitant linezolid or IV methylene blue; if treatment is necessary, discontinue olanzapine/fluoxetine before starting; monitor for serotonin syndrome for 5 weeks or until 24hrs after last dose of linezolid or IV methylene blue, whichever comes first. Do not start thioridazine within at least 5 weeks of discontinuing olanzapine/fluoxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Avoid concomitant drugs known to prolong the QT interval (eg, ziprasidone, iloperidone, chlorpromazine, erythromycin, moxifloxacin, Class IA & III antiarrhythmics, pentamidine, methadone, and others. May potentiate phenytoin, carbamazepine, haloperidol, clozapine, imipramine, desipramine, benzodiazepines, other protein bound drugs. May antagonize levodopa, dopamine agonists. May be potentiated by CYP1A2 inhibitors (eg, fluvoxamine). May be antagonized by CYP1A2 inducers (eg, carbamazepine), glucuronyl transferase enzyme inducers (rifampin, omeprazole). Increased risk of bleeding with NSAIDs, aspirin, warfarin, or others that affect coagulation; monitor. Orthostatic hypotension with antihypertensives, benzodiazepines, alcohol (avoid). Hyponatremia with diuretics. Caution with other drugs metabolized by CYP2D6 (eg, tricyclic antidepressants, antipsychotics, antiarrhythmics), drugs that lower seizure threshold, other CNS drugs, hepatotoxic agents, anticholinergics, other forms of olanzapine or fluoxetine. Smokers may have increased metabolism.
Symbyax Adverse Reactions
Adverse Reactions
Symbyax Clinical Trials
See Literature
Symbyax Note
Not Applicable
Symbyax Patient Counseling
See Literature