FDA Label for Tramadol Hydrochloride

View Indications, Usage & Precautions

    1. 1 INDICATIONS AND USAGE
    2. 2.1 GENERAL DOSING CONSIDERATIONS
    3. 2.2    PATIENTS NOT CURRENTLY ON TRAMADOL IMMEDIATE-RELEASE PRODUCTS
    4. 2.3    PATIENTS CURRENTLY ON TRAMADOL IMMEDIATE-RELEASE PRODUCTS
    5. 2.4    PATIENTS 65 YEARS OF AGE AND OLDER
    6. 2.5    PATIENTS WITH RENAL IMPAIRMENT
    7. 2.6    PATIENTS WITH HEPATIC IMPAIRMENT
    8. 2.7    DISCONTINUATION OF TREATMENT
    9. 2.8    FOOD EFFECTS
    10. 3       DOSAGE FORMS AND STRENGTHS
    11. 4       CONTRAINDICATIONS
    12. 5.1    SEIZURE RISK
    13. 5.2    SUICIDE RISK
    14. 5.3    SEROTONIN SYNDROME RISK
    15. 5.4    ANAPHYLACTOID REACTIONS
    16. 5.5    RESPIRATORY DEPRESSION
    17. 5.6    INTERACTION WITH CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL AND DRUGS OF ABUSE
    18. 5.7    PATIENTS WITH INCREASED INTRACRANIAL PRESSURE OR HEAD TRAUMA
    19. 5.8    USE IN AMBULATORY PATIENTS
    20. 5.9    USE WITH MAO INHIBITORS AND SSRIS
    21. 5.10    WITHDRAWAL SYMPTOMS
    22. 5.11    MISUSE, ABUSE AND DIVERSION OF OPIOIDS
    23. 5.12    RISK OF OVERDOSAGE
    24. 5.13    ACUTE ABDOMINAL CONDITIONS
    25. 6       ADVERSE REACTIONS
    26. 6.1    CLINICAL STUDIES EXPERIENCE
    27. 7.1    DRUGS AFFECTING SEIZURE THRESHOLD
    28. 7.2    CYP2D6 AND/OR CYP3A4 INHIBITORS
    29. 7.3    SEROTONERGIC DRUGS
    30. 7.4    TRIPTANS
    31. 7.5    INTERACTION WITH CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
    32. 7.6    QUINIDINE
    33. 7.7    DIGOXIN AND WARFARINS
    34. 7.8    CYP3A4 INDUCERS
    35. 8.1    PREGNANCY
    36. 8.2    LABOR AND DELIVERY
    37. 8.3    NURSING MOTHERS
    38. 8.4    PEDIATRIC USE
    39. 8.5    GERIATRIC USE
    40. 8.6    PATIENTS WITH RENAL IMPAIRMENT
    41. 8.7    PATIENTS WITH HEPATIC IMPAIRMENT
    42. 9.1    CONTROLLED SUBSTANCE
    43. 9.2    ABUSE
    44. 9.3    USE IN DRUG AND ALCOHOL ADDICTION
    45. 9.4    DEPENDENCE
    46. 9.5    WITHDRAWAL SYMPTOMS
    47. 10.1    HUMAN EXPERIENCE
    48. 10.2    MANAGEMENT OF OVERDOSE
    49. 11       DESCRIPTION
    50. 12.1    MECHANISM OF ACTION
    51. 12.2    PHARMACODYNAMICS
    52. 12.3    PHARMACOKINETICS
    53. 13.1    CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    54. 14       CLINICAL STUDIES
    55. 16       HOW SUPPLIED/STORAGE AND HANDLING
    56. 17       PATIENT COUNSELING INFORMATION
    57. PRINCIPAL DISPLAY PANEL

Tramadol Hydrochloride 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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