Monograph Details
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Central Nervous System
> Mood disorders
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SYMBYAX 6mg/25mg |
| Manufacturer |
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Lilly, Eli and Company |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Thienobenzodiazepine + SSRI. |
| Generic Name |
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Olanzapine 6mg, fluoxetine (as HCl) 25mg; caps. |
| Also |
• SYMBYAX 12mg/25mg
• SYMBYAX 12mg/50mg
• SYMBYAX 6mg/50mg
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| Indications |
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Depressive episodes associated with bipolar disorder. |
| Children |
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Not recommended. |
| Adults |
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Take once daily in the PM. Initially one 6mg/25mg cap; range: 6–12mg/25–50mg; max 18mg/75mg per day. |
| Contraindications |
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During or within 14 days of MAOIs. Concomitant pimozide or thioridazine (may cause QTc prolongation). |
| Precautions |
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Cardio- or cerebrovascular disease. Hepatic impairment (monitor ALT/AST). Hypovolemia. Dehydration. Seizures. Diseases that affect metabolism or hemodynamic response. Diabetes. Narrow angle glaucoma. Prostatic hypertrophy. History of paralytic ileus or breast cancer. Exposure to extreme heat. Dysphagia. Suicidal ideation. Reevaluate periodically. Write Rx for smallest practical amount. Avoid abrupt cessation. Elderly (esp. with dementia). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Do not start MAOI or thioridazine within at least 5 weeks of discontinuing fluoxetine. Increased CNS stimulation with tryptophan. May increase phenytoin, carbamazepine, haloperidol, clozapine levels. May potentiate other protein bound drugs and those metabolized by CYP2D6 (eg, tricyclics). May be potentiated by CYP1A2 inhibitors (eg, fluvoxamine). May antagonize levodopa, dopamine agonists. May be antagonized by carbamazepine, rifampin, omeprazole, other CYP1A2 or glucuronyl transferase inducers. Increased risk of bleeding with NSAIDs, aspirin, warfarin, others that affect coagulation. Orthostatic hypotension with antihypertensives, benzodiazepines, alcohol, others. Hyponatremia with diuretics. Monitor lithium, tricyclics, sumatriptan, phenytoin, warfarin. Caution with other antipsychotics, benzodiazepines, drugs that lower seizure threshold, other CNS drugs, hepatotoxic agents, anticholinergics, other forms of olanzapine or fluoxetine. Smokers may have increased metabolism. |
| Adverse Reactions |
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Asthenia, edema, weight gain, tremor, pharyngitis, increased appetite, somnolence, abnormal thinking, orthostatic hypotension; rare: neuroleptic malignant syndrome, tardive dyskinesia, hyponatremia, hyperprolactinemia, mania/hypomania, elevated liver enzymes. |
| How Supplied |
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Caps—30, 100, 1000 |
| Additional Resources |
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• Related Prescribing Note |
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