FDA Label for Topiramate

View Indications, Usage & Precautions

    1. 1.1 MONOTHERAPY EPILEPSY
    2. 1.2 ADJUNCTIVE THERAPY EPILEPSY
    3. 1.3 MIGRAINE
    4. 2.1 DOSING IN MONOTHERAPY EPILEPSY
    5. 2.2 DOSING IN ADJUNCTIVE THERAPY EPILEPSY
    6. 2.3 DOSING IN MIGRAINE PROPHYLAXIS
    7. 2.4 ADMINISTRATION INFORMATION
    8. 2.5 DOSING IN PATIENTS WITH RENAL IMPAIRMENT
    9. 2.6 DOSING IN PATIENTS UNDERGOING HEMODIALYSIS
    10. DOSAGE, FORM & STRENGTH
    11. 5.1 ACUTE MYOPIA AND SECONDARY ANGLE CLOSURE GLAUCOMA
    12. 5.2 VISUAL FIELD DEFECTS
    13. 5.3 OLIGOHIDROSIS AND HYPERTHERMIA
    14. 5.4 METABOLIC ACIDOSIS
    15. 5.5 SUICIDAL BEHAVIOR AND IDEATION
    16. 5.6 COGNITIVE/NEUROPSYCHIATRIC ADVERSE REACTIONS
    17. 5.7 FETAL TOXICITY
    18. 5.8 WITHDRAWAL OF ANTIEPILEPTIC DRUGS
    19. 5.9 HYPERAMMONEMIA AND ENCEPHALOPATHY (WITHOUT AND WITH CONCOMITANT VALPROIC ACID
    20. 5.10 KIDNEY STONES
    21. 5.11 HYPOTHERMIA WITH CONCOMITANT VALPROIC ACID (VPA)
    22. MONOTHERAPY EPILEPSY
    23. ADJUNCTIVE THERAPY EPILEPSY
    24. INCIDENCE IN EPILEPSY CONTROLLED CLINICAL TRIALS – ADJUNCTIVE THERAPY – PARTIAL ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND LENNOX-GASTAUT SYNDROME
    25. OTHER ADVERSE REACTIONS OBSERVED DURING DOUBLE-BLIND EPILEPSY ADJUNCTIVE THERAPY TRIALS
    26. INCIDENCE IN STUDY 119 – ADD-ON THERAPY– ADULTS WITH PARTIAL ONSET SEIZURES
    27. OTHER ADVERSE REACTIONS OBSERVED DURING ALL EPILEPSY CLINICAL TRIALS
    28. 6.2 POSTMARKETING EXPERIENCE
    29. 7.1 ANTIEPILEPTIC DRUGS
    30. 7.2 CNS DEPRESSANTS
    31. 7.3 ORAL CONTRACEPTIVES
    32. 7.4 LITHIUM
    33. 7.5 OTHER CARBONIC ANHYDRASE INHIBITORS
    34. 7.6 HYDROCHLOROTHIAZIDE (HCTZ)
    35. 7.7 PIOGLITAZONE
    36. 7.8 AMITRIPTYLINE
    37. 8.1 PREGNANCY
    38. 8.2 LABOR AND DELIVERY
    39. 8.3 NURSING MOTHERS
    40. 8.4 PEDIATRIC USE
    41. 8.5 GERIATRIC USE
    42. 8.6 RENAL IMPAIRMENT
    43. 8.7 PATIENTS UNDERGOING HEMODIALYSIS
    44. 8.8 WOMEN OF CHILDBEARING POTENTIAL
    45. 10 OVERDOSAGE
    46. 11 DESCRIPTION
    47. 12.1 MECHANISM OF ACTION
    48. 12.2 PHARMACODYNAMICS
    49. 12.3 PHARMACOKINETICS
    50. 13.1 CARCINOGENESIS, MUTAGENESIS IMPAIRMENT OF FERTILITY
    51. 14 CLINICAL STUDIES
    52. 14.1 MONOTHERAPY EPILEPSY
    53. 14.2 ADJUNCTIVE THERAPY EPILEPSY
    54. 14.3 MIGRAINE PROPHYLAXIS
    55. 16.1 HOW SUPPLIED
    56. 16.2 STORAGE AND HANDLING
    57. 17 PATIENT COUNSELING INFORMATION
    58. MEDICATION GUIDE
    59. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topiramate Product Label

The following document was submitted to the FDA by the labeler of this product Aidarex Pharmaceuticals Llc. 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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