Drugplain

Olanzapine and Fluoxetine 25 mg/1

Olanzapine and Fluoxetine · CAPSULE · Teva Pharmaceuticals USA, Inc.

No Recall History
Plain English

Olanzapine and Fluoxetine is a capsule containing olanzapine and fluoxetine at 25 mg/1, taken oral. Manufactured by Teva Pharmaceuticals USA, Inc..

Key Facts

Brand Name
Olanzapine and Fluoxetine
Generic Name
Olanzapine and Fluoxetine
NDC Code (Product)
0093-5504
Manufacturer
Teva Pharmaceuticals USA, Inc.
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA077528
Drug Class
Atypical Antipsychotic [EPC]
Marketing Start
06/19/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death4 reports
completed suicide3 reports
nausea3 reports
toxicity to various agents3 reports
asthenia2 reports
constipation2 reports
dehydration2 reports
hypoxia2 reports
somnolence2 reports
treatment failure2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Olanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)] . Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)] . Olanzapine and fluoxetine capsules combines olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) Treatment Resistant Depression ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult Starting Dose: 6 mg olanzapine with 25 mg fluoxetine (6 mg/25 mg, once daily in the evening ( 2.1 , 2.2 ) Adult Maximum Dose: 12 mg/50 mg once daily ( 2.1 , 2.2 ) Pediatric Bipolar Depression Starting Dose: 3 mg/25 mg once daily (for ages 10 to 17 years) ( 2.1 ) Pediatric Bipolar Depression Maximum Dose: 12 mg/50 mg ( 2.1 ) 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 ( 2.3 ) 2.1 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 capsules have not been studied. Make dosage adjustments, 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 12 mg and fluoxetine 25 m…

Contraindications

4 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. (4.1) P imozide : Do not use. Risk of QT interval prolongation (4.2, 5.20, 7.7, 7.8) Thioridazine : Do not use. Risk of QT interval prolongation. Do not use thioridazine within 5 weeks of discontinuing olanzapine and fluoxetine capsules (4.2, 5.20, 7.7, 7.8) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with olanzapine and fluoxetine capsules or within 5 weeks of stopping treatment with olanzapine and fluoxetine capsules is contraindicated because of an increased risk of serotonin syndrome. The use of olanzapine and fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric…

Drug Interactions

7 DRUG INTERACTIONS The risks of using olanzapine and fluoxetine capsules 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 capsules. 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 [see Clinical Pharmacology (12.3)] . Monoamine Oxidase Inhibitor (MAOI) : (2.4, 2.5, 4.1, 5.6, 7.1) Drugs Metabolized by CYP2D6 : Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway (7.7) Tricyclic Antidepressants (TCAs) : Monitor TCA levels during coadministration with olanzapine and fluoxetine capsules or when olanzapine and fluoxetine capsules have been recently discontinued (5.6, 7.7) CN S Acting Drugs : Caution is advised if the concomitant administration of olanzapine and fluoxetine capsules and other CNS-active drugs is…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2)] Neuroleptic Malignant syndrome (NMS) [see Warnings and Precautions (5.3)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4)] Hyperglycemia [see Warnings and Precautions (5.5)] Dyslipidemia [see Warnings and Precautions (5.5)] Weight Gain [see Warnings and Precautions (5.5)] Serotonin Syndrome [see Warnings and Precautions (5.6)] Angle-Closure Glaucoma [see Warnings and Precautions (5.7)] Allergic Reactions and Rash [see Warnings and Precautions (5.8)] Activation of Mania/Hypomania [see Warnings and Precautions (5.9)] Tardive Dyskinesia [see Warnings and Precautions (5.10)] Orthostatic Hypotension [see Warnings and Precautions (5.11)] Falls [see Warnings and Precautions (5.12)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.13)] Dysphagia [see Warnings and …

Frequently Asked Questions

What is Olanzapine and Fluoxetine used for?

Olanzapine and Fluoxetine contains Olanzapine and Fluoxetine. It is a capsule taken oral. Consult your doctor for specific uses.

Is Olanzapine and Fluoxetine a controlled substance?

Olanzapine and Fluoxetine is not classified as a controlled substance by the DEA.

What is the generic name for Olanzapine and Fluoxetine?

The generic name for Olanzapine and Fluoxetine is Olanzapine and Fluoxetine. There are no other listed brand versions of Olanzapine and Fluoxetine.

What is the NDC code for Olanzapine and Fluoxetine 25 mg/1?

The NDC (National Drug Code) for Olanzapine and Fluoxetine 25 mg/1 is 0093-5504, listed by Teva Pharmaceuticals USA, Inc..

Product NDC

0093-5504

Package NDC

0093-5504-56

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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