FDA Label for Phenytoin Sodium

View Indications, Usage & Precautions

    1. WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
    2. 1 INDICATIONS AND USAGE
    3. 2.1 GENERAL DOSING INFORMATION
    4. 2.2  STATUS EPILEPTICUS
    5. 2.3  NON-EMERGENT LOADING AND MAINTENANCE DOSING
    6. 2.4  PARENTERAL SUBSTITUTION FOR ORAL PHENYTOIN THERAPY
    7. 2.5  DOSING IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT OR HYPOALBUMINEMIA
    8. 2.6  DOSING IN GERIATRICS
    9. 2.7  DOSING DURING PREGNANCY
    10. 2.8  DOSING IN PEDIATRICS
    11. 3 DOSAGE FORMS AND STRENGTHS
    12. 4 CONTRAINDICATIONS
    13. 5.1  CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION
    14. 5.2  WITHDRAWAL PRECIPITATED SEIZURE, STATUS EPILEPTICUS
    15. 5.3  SERIOUS DERMATOLOGIC REACTIONS
    16. 5.4  DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)/MULTIORGAN HYPERSENSITIVITY
    17. 5.5  HYPERSENSITIVITY
    18. 5.6  HEPATIC INJURY
    19. 5.7  HEMATOPOIETIC COMPLICATIONS
    20. 5.8 LOCAL TOXICITY (INCLUDING PURPLE GLOVE SYNDROME)
    21. 5.9     RENAL OR HEPATIC IMPAIRMENT OR HYPOALBUMINEMIA
    22. 5.10   EXACERBATION OF PORPHYRIA
    23. 5.11   TERATOGENICITY AND OTHER HARM TO THE NEWBORN
    24. 5.12   HYPERGLYCEMIA
    25. 5.13   SERUM PHENYTOIN LEVELS ABOVE THERAPEUTIC RANGE
    26. 6 ADVERSE REACTIONS
    27. 7 DRUG INTERACTIONS
    28. 7.1 DRUGS THAT AFFECT PHENYTOIN CONCENTRATIONS
    29. 7.2 DRUGS AFFECTED BY PHENYTOIN
    30. 7.3  DRUG/LABORATORY TEST INTERACTIONS
    31. 8.1 PREGNANCY
    32. 8.2 LACTATION
    33. 8.4 PEDIATRIC USE
    34. 8.5 GERIATRIC USE
    35. 8.6 RENAL AND/OR HEPATIC IMPAIRMENT OR HYPOALBUMINEMIA
    36. 8.7 USE IN PATIENTS WITH DECREASED CYP2C9 FUNCTION
    37. 10 OVERDOSAGE
    38. 11 DESCRIPTION
    39. 12.1 MECHANISM OF ACTION
    40. 12.3 PHARMACOKINETICS
    41. 12.5 PHARMACOGENOMICS
    42. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    43. 16.1     HOW SUPPLIED
    44. 16.2     STORAGE AND HANDLING
    45. 17 PATIENT COUNSELING INFORMATION
    46. PRINCIPAL DISPLAY PANEL

Phenytoin Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Medical Purchasing Solutions, 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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