FDA Label for Olanzapine

View Indications, Usage & Precautions

    1. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
    2. 1.1 SCHIZOPHRENIA
    3. 1.2 BIPOLAR I DISORDER (MANIC OR MIXED EPISODES)
    4. 1.3 SPECIAL CONSIDERATIONS IN TREATING PEDIATRIC SCHIZOPHRENIA AND BIPOLAR I DISORDER
    5. 1.5 OLANZAPINE AND FLUOXETINE IN COMBINATION: DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
    6. 1.6 OLANZAPINE AND FLUOXETINE IN COMBINATION: TREATMENT RESISTANT DEPRESSION
    7. 2.1 SCHIZOPHRENIA
    8. 2.2 BIPOLAR I DISORDER (MANIC OR MIXED EPISODES)
    9. 2.3 ADMINISTRATION OF OLANZAPINE ORALLY DISINTEGRATING TABLETS
    10. 2.5 OLANZAPINE AND FLUOXETINE IN COMBINATION: DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
    11. 2.6 OLANZAPINE AND FLUOXETINE IN COMBINATION: TREATMENT RESISTANT DEPRESSION
    12. 2.7 OLANZAPINE AND FLUOXETINE IN COMBINATION: DOSING IN SPECIAL POPULATIONS
    13. 3 DOSAGE FORMS AND STRENGTHS
    14. 4 CONTRAINDICATIONS
    15. 5.1 ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
    16. 5.2 SUICIDE
    17. 5.3 NEUROLEPTIC MALIGNANT SYNDROME (NMS)
    18. 5.4 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
    19. 5.5 METABOLIC CHANGES
    20. 5.6 TARDIVE DYSKINESIA
    21. 5.7 ORTHOSTATIC HYPOTENSION
    22. 5.8 FALLS
    23. 5.9 LEUKOPENIA, NEUTROPENIA, AND AGRANULOCYTOSIS
    24. 5.10 DYSPHAGIA
    25. 5.11 SEIZURES
    26. 5.12 POTENTIAL FOR COGNITIVE AND MOTOR IMPAIRMENT
    27. 5.13 BODY TEMPERATURE REGULATION
    28. 5.14 ANTICHOLINERGIC (ANTIMUSCARINIC) EFFECTS
    29. 5.15 HYPERPROLACTINEMIA
    30. 5.16 USE IN COMBINATION WITH FLUOXETINE, LITHIUM, OR VALPROATE
    31. 5.17 LABORATORY TESTS
    32. 6 ADVERSE REACTIONS
    33. 6.1 CLINICAL TRIALS EXPERIENCE
    34. 6.2 POSTMARKETING EXPERIENCE
    35. 7 DRUG INTERACTIONS
    36. 7.1 POTENTIAL FOR OTHER DRUGS TO AFFECT OLANZAPINE
    37. 7.2 POTENTIAL FOR OLANZAPINE TO AFFECT OTHER DRUGS
    38. 8 USE IN SPECIFIC POPULATIONS
    39. 8.1 PREGNANCY
    40. 8.2 LACTATION
    41. 8.3 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
    42. 8.4 PEDIATRIC USE
    43. 8.5 GERIATRIC USE
    44. 9.3 DEPENDENCE
    45. 10.1 HUMAN EXPERIENCE
    46. 10.2 MANAGEMENT OF OVERDOSE
    47. 11 DESCRIPTION
    48. 12.1 MECHANISM OF ACTION
    49. 12.2 PHARMACODYNAMICS
    50. 12.3 PHARMACOKINETICS
    51. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    52. 13.2 ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
    53. 14 CLINICAL STUDIES
    54. 14.1 SCHIZOPHRENIA
    55. 14.2 BIPOLAR I DISORDER (MANIC OR MIXED EPISODES)
    56. 16.1 HOW SUPPLIED
    57. 16.2 STORAGE AND HANDLING
    58. 17 PATIENT COUNSELING INFORMATION
    59. MEDICATION GUIDE
    60. OLANZAPINE TABLETS USP-CONTAINER LABEL
    61. OLANZAPINE ORALLY DISINTEGRATING TABLETS-CONTAINER LABEL

Olanzapine Product Label

The following document was submitted to the FDA by the labeler of this product Hisun Pharmaceuticals Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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