Olanzapine and Fluoxetine

OLANZAPINE and FLUOXETINE CAPSULES, for oral use

Olanzapine and Fluoxetine

Olanzapine and fluoxetine capsules USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa®, and Zyprexa Zydis®) and fluoxetine hydrochloride (the active ingredient in Prozac®, and Sarafem®).

Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10Hthieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44.

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3‑[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NO•HCl, which corresponds to a molecular weight of 345.79.

Olanzapine is a yellow crystalline solid, which is practically insoluble in water.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol.

Mechanism of Action

The mechanism of action of olanzapine and fluoxetine in the listed indications, is unclear. However, the combined effect of olanzapine and fluoxetine at the monoaminergic neural systems (serotonin, norepinephrine, and dopamine) could be responsible for the pharmacological effect.

WARNING

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the healthcare provider.

Olanzapine and Fluoxetine Capsules are not approved for use in children less than 10 years of age

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine and Fluoxetine Capsules are not approved for the treatment of patients with dementia-related psychosis

INDICATIONS AND USAGE

Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of:

  • Acute Depressive Episodes Associated with Bipolar I Disorder.
  • Treatment Resistant Depression

DOSAGE AND ADMINISTRATION

Adult Maximum Dose: 12 mg/50 mg once daily

Pediatric Bipolar Depression Starting Dose: 3 mg/25 mg once daily (for ages 10 to 17 years)

Pediatric Bipolar Depression Maximum Dose: 12 mg/50 mg

Starting dose in patients predisposed to hypotensive reactions, hepatic impairment, or with potential for slowed metabolism: 3 mg/25 mg  to 6 mg /25 mg. Escalate dose cautiously

Depressive Episodes Associated with Bipolar I Disorder

Adults: Administer Olanzapine and Fluoxetine Capsules once daily in the evening, generally beginning with the 6 mg/25 mg (mg olanzapine/mg equivalent fluoxetine) capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of olanzapine and fluoxetine has not been studied. Make dosage adjustments, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg

The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Children and Adolescents (10 to 17 years of age): Administer Olanzapine and Fluoxetine Capsules once daily in the evening, generally beginning with the 3 mg/25 mg capsule, without regard to meals, with a recommended target dose within the approved dosing range (6/25; 6/50; 12/25; 12/50 mg)

The safety of doses above 12 mg of olanzapine and 50 mg of fluoxetine has not been evaluated in pediatric clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Treatment Resistant Depression

Administer Olanzapine and Fluoxetine Capsules 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 Olanzapine and Fluoxetine Capsules has not been studied. Adjust dosage, if indicated, according to efficacy and tolerability.

Antidepressant efficacy was demonstrated with Olanzapine and Fluoxetine Capsules in a dose range of olanzapine 6 mg to 18 mg and fluoxetine 25 mg to 50 mg

The safety of doses above 18 mg/75 mg has not been evaluated in clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Switching a Patient To or From a Monamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders, and initiation of therapy with olanzapine and fluoxetine. Conversely, at least 5 weeks should be allowed after stopping olanzapine and fluoxetine before starting an MAOI intended to treat psychiatric disorders

Use of Olanzapine and Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene Blue

Do not start olanzapine and fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors (MAOI): Because of the risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with Olanzapine and Fluoxetine Capsules or within 5 weeks of stopping treatment with Olanzapine and Fluoxetine Capsules. Do not use Olanzapine and Fluoxetine Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Olanzapine and Fluoxetine Capsules in a patient who is being treated with linezolid or intravenous methylene blue.

Pimozide: Do not use. Risk of QT interval prolongation

Thioridazine: Do not use. Risk of QT interval prolongation. Do not use thioridazine within 5 weeks of discontinuing Olanzapine and Fluoxetine Capsules

WARNINGS AND PRECAUTIONS

Hyperglycemia and Diabetes Mellitus: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death. Monitor for symptoms of hyperglycemia. Perform fasting blood glucose testing before beginning, and periodically during treatment.

Dyslipidemia: Appropriate clinical monitoring is recommended, including fasting blood lipid testing before beginning and periodically during, treatment

Weight Gain: Consider potential consequences of weight gain. Monitor weight regularly

Serotonin Syndrome: Serotonin Syndrome has been reported with SSRIs and SNRIs, including Olanzapine and fluoxetine capsules, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort). If such symptoms occur, discontinue Olanzapine and fluoxetine capsules and initiate supportive treatment. If concomitant use of Olanzapine and fluoxetine capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk of serotonin syndrome, particularly during treatment initiation and dose increases

Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants

Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena

Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for activation of mania/hypomania

Tardive Dyskinesia: A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment.

Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration. Use caution in patients with cardiovascular disease or cerebrovascular disease, and those conditions that could affect hemodynamic responses

Leukopenia, Neutropenia, and Agranulocytosis: Has been reported with antipsychotics, including olanzapine and fluoxetine. Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/ neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy. Consider discontinuing Olanzapine and fluoxetine capsules at the first sign of a clinically significant decline in WBC in the absence of other causative factors

Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold

Abnormal Bleeding: SSRIs increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding

Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing Olanzapine and Fluoxetine capsules if symptomatic hyponatremia occurs

Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery

Body Temperature Dysregulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic drugs. Appropriate care is advised when prescribing olanzapine and fluoxetine HCl for patients who will be experiencing conditions which may contribute to an elevation in core body temperature (e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration).  

QT Prolongation: QT prolongation and ventricular arrhythmia including Torsade de Pointes have been reported with fluoxetine. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation

Anticholinergic (antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, history of paralytic ileus or related conditions

Hyperprolactinemia: May elevate prolactin levels

Long Elimination Half-Life of Fluoxetine: Because of the long elimination half-lives of fluoxetine and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment. This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with fluoxetine and norfluoxetine following the discontinuation of fluoxetine

Sexual Dysfunction: Use of SSRIs, including fluoxetine a component of olanzapine and fluoxetine, may cause symptoms of sexual dysfunction. In male patients, olanzapine and fluoxetine use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, olanzapine and fluoxetine use may result in decreased libido and delayed or absent orgasm.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Increased Mortality: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine and fluoxetine HCl is not approved for the treatment of patients with dementia-related psychosis 

Cerebrovascular Adverse Events (CVAE), Including Stroke: Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to patients treated with placebo. Olanzapine and olanzapine and fluoxetine HCl are not approved for the treatment of patients with dementia-related psychosis

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including olanzapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. DRESS is sometimes fatal. Discontinue olanzapine and fluoxetine capsules if DRESS is suspected.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s disease. Olanzapine and fluoxetine is not approved for the treatment of patients with Alzheimer’s disease.

Falls: Olanzapine and fluoxetine may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

ADVERSE REACTIONS

  • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Neuroleptic Malignant syndrome (NMS)
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  • Hyperglycemia
  • Dyslipidemia
  • Weight Gain
  • Serotonin Syndrome
  • Angle-Closure Glaucoma
  • Allergic Reactions and Rash
  • Activation of Mania/Hypomania
  • Tardive Dyskinesia
  • Orthostatic Hypotension
  • Falls
  • Leukopenia, Neutropenia, and Agranulocytosis
  • Dysphagia
  • Seizures
  • Abnormal Bleeding
  • Hyponatremia
  • Potential for Cognitive and Motor Impairment
  • Body Temperature Dysregulation
  • QT Prolongation
  • Anticholinergic (antimuscarinic) Effects
  • Hyperprolactinemia
  • Discontinuation Adverse Reactions
  • Sexual Dysfunction

Most common adverse reactions (≥5% and at least twice that for placebo) in adults: sedation, weight increased, appetite increased, dry mouth, fatique, edema, tremor, disturbance in attention, blurred vision. Children and adolescents: sedation weight increased, appetite increased, tremor, triglyceride increased, hepatic enzymes increased

To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

The risks of using olanzapine and fluoxetine in combination with other drugs have not been extensively evaluated in systematic studies. The drug-drug interactions sections of fluoxetine and olanzapine are applicable to olanzapine and fluoxetine HCl. As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status

Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with olanzapine and fluoxetine hydrochloride or when olanzapine and fluoxetine hydrochloride have been recently discontinued

CNS Acting Drugs: Caution is advised if the concomitant administration of olanzapine and fluoxetine hydrochloride and other CNS-active drugs is required

Antihypertensive Agent: Enhanced antihypertensive effect

Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists

Benzodiazepines: May potentiate orthostatic hypotension and sedation

Clozapine: May elevate clozapine levels

Haloperidol: Elevated haloperidol levels have been observed

Carbamazepine: Potential for elevated carbamazepine levels and clinical anticonvulsant toxicity

Phenytoin: Potential for elevated phenytoin levels and clinical anticonvulsant toxicity

Alcohol: May potentiate sedation and orthostatic hypotension

Fluvoxamine: May increase olanzapine levels; a lower dose of the olanzapine component of olanzapine and fluoxetine hydrochloride should be considered

Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin, etc.): May potentiate the risk of bleeding

Drugs Tightly Bound to Plasma Proteins: Fluoxetine may cause shift in plasma concentrations

Drugs that Prolong the QT Interval: Do not use olanzapine and fluoxetine capsules in combination with thioridazine or pimozide. Use olanzapine and fluoxetine capsules with caution in combination with other drugs that prolong the QT interval

USE IN SPECIFIC POPULATIONS

Pregnancy : SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability, tremor) in the neonate. Olanzapine may cause extrapyramidal symptoms and/or withdrawal symptoms in neonates with third trimester exposure.

Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and the postpartum.

Pediatric Use: Safety and efficacy of olanzapine and fluoxetine capsules for the treatment of bipolar I depression in patients under 10 years of age have not been established. Safety and efficacy of olanzapine and fluoxetine capsules for treatment resistant depression in patients under 18 years of age have not been established

Hepatic Impairment: Use a lower or less frequent dose in patients with cirrhosis

Lactation: Data from published literature report the presence of olanzapine, fluoxetine, and norfluoxetine in human milk

There are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk and reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to fluoxetine through breast milk

There is no information on the effects of olanzapine or fluoxetine and their metabolites on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olanzapine and fluoxetine capsules and any potential adverse effects on the breastfed child from olanzapine and fluoxetine capsules or the underlying maternal condition.

Infants exposed to olanzapine and fluoxetine capsules should be monitored for agitation, irritability, poor feeding, poor weight gain, excess sedation, and extrapyramidal symptoms (tremors and abnormal muscle movements).

Geriatric Use

Clinical studies of olanzapine and fluoxetine did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

DRUG ABUSE AND DEPENDENCE

Dependence

Olanzapine and fluoxetine HCl, as with fluoxetine and olanzapine, has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical studies did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, healthcare providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of olanzapine and fluoxetine HCl (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

In studies in rats and rhesus monkeys designed to assess abuse and dependence potential, olanzapine alone was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence at oral doses up to 15 (rat) and 8 (monkey) times the MRHD (20 mg) on a mg/m2 basis.

OVERDOSAGE

Olanzapine and Fluoxetine

During premarketing clinical studies of olanzapine and fluoxetine in combination, overdose of both fluoxetine and olanzapine were reported in 5 study subjects. Four of the 5 subjects experienced loss of consciousness (3) or coma (1). No fatalities occurred.

Adverse reactions involving overdose of fluoxetine and olanzapine in combination, and olanzapine and fluoxetine HCl, have been reported. An overdose of combination therapy is defined as confirmed or suspected ingestion of a dose of >20 mg olanzapine in combination with a dose of >80 mg fluoxetine. Adverse reactions associated with these reports included somnolence (sedation), impaired consciousness (coma), impaired neurologic function (ataxia, confusion, convulsions, dysarthria), arrhythmias, lethargy, essential tremor, agitation, acute psychosis, hypotension, hypertension, and aggression. Fatalities have been confounded by exposure to additional substances including alcohol, thioridazine, oxycodone, and propoxyphene.

Olanzapine

In postmarketing reports of overdose with olanzapine alone, symptoms have been reported in the majority of cases. In symptomatic patients, symptoms with ≥10% incidence included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Among less commonly reported symptoms were the following potentially medically serious reactions: aspiration, cardiopulmonary arrest, cardiac arrhythmias (such as supraventricular tachycardia as well as a patient that experienced sinus pause with spontaneous resumption of normal rhythm), delirium, possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion, hypertension, and hypotension. There have been reports of fatality in association with overdose of olanzapine alone. In 1 case of death, the amount of acutely ingested olanzapine was reported to be possibly as low as 450 mg of oral olanzapine; however, in another case, a patient was reported to survive an acute olanzapine ingestion of approximately 2 g of oral olanzapine.

Fluoxetine

The following have been reported with fluoxetine overdosage: 

Seizures, which may be delayed, and altered mental status including coma. 

Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, Torsade de Pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. 

Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk). 

Management of Overdose

For current information on the management of olanzapine and fluoxetine overdose, consider contacting a Certified Poison Control Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. In managing overdose, consider the possibility of multiple drug involvement.  Establish and maintain an airway and ensure adequate ventilation. Commence cardiovascular monitoring immediately and include continuous electrocardiographic monitoring to detect possible arrhythmias.

A specific precaution involves patients who are taking or have recently taken olanzapine and fluoxetine and may have ingested excessive quantities of a TCA (tricyclic antidepressant). In such cases, accumulation of the parent TCA and/or an active metabolite increases the possibility of serious sequelae and extends the time needed for close medical observation.

Due to the large volume of distribution of olanzapine and fluoxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidote for either fluoxetine or olanzapine overdose is known

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