FDA Label for Alprazolam Extended Release

View Indications, Usage & Precautions

    1. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
    2. 1 INDICATIONS AND USAGE
    3. 2.1 RECOMMENDED DOSAGE
    4. 2.2 DISCONTINUATION OR DOSAGE REDUCTION OF ALPRAZOLAM EXTENDED-RELEASE TABLETS
    5. 2.3 DOSAGE RECOMMENDATIONS IN GERIATRIC PATIENTS
    6. 2.4 DOSAGE RECOMMENDATIONS IN PATIENTS WITH HEPATIC IMPAIRMENT
    7. 2.5 DOSAGE MODIFICATIONS FOR DRUG INTERACTIONS
    8. 2.6 SWITCHING PATIENTS FROM ALPRAZOLAM TABLETS TO ALPRAZOLAM EXTENDED-RELEASE TABLETS
    9. 3 DOSAGE FORMS AND STRENGTHS
    10. 4 CONTRAINDICATIONS
    11. 5.1 RISKS FROM CONCOMITANT USE WITH OPIOIDS
    12. 5.2 ABUSE, MISUSE, AND ADDICTION
    13. 5.3 DEPENDENCE AND WITHDRAWAL REACTIONS
    14. 5.4 EFFECTS ON DRIVING AND OPERATING MACHINERY
    15. 5.5 NEONATAL SEDATION AND WITHDRAWAL SYNDROME
    16. 5.6 INTERACTION WITH DRUGS THAT INHIBIT METABOLISM VIA CYTOCHROME P450 3A
    17. 5.7 PATIENTS WITH DEPRESSION
    18. 5.8 MANIA
    19. 5.9 RISKS IN PATIENTS WITH IMPAIRED RESPIRATORY FUNCTION
    20. 6 ADVERSE REACTIONS
    21. 6.1 CLINICAL TRIALS EXPERIENCE
    22. 6.2 POSTMARKETING EXPERIENCE
    23. 7.1 DRUGS HAVING CLINICALLY IMPORTANT INTERACTIONS WITH ALPRAZOLAM EXTENDED-RELEASE TABLETS
    24. 7.2 DRUG/LABORATORY TEST INTERACTIONS
    25. 8.1 PREGNANCY
    26. 8.2 LACTATION
    27. 8.4 PEDIATRIC USE
    28. 8.5 GERIATRIC USE
    29. 8.6 HEPATIC IMPAIRMENT
    30. 9.1 CONTROLLED SUBSTANCE
    31. 9.2 ABUSE
    32. 9.3 DEPENDENCE
    33. 10.1 CLINICAL EXPERIENCE
    34. 10.2 MANAGEMENT OF OVERDOSE
    35. 11 DESCRIPTION
    36. 12.1 MECHANISM OF ACTION
    37. 12.3 PHARMACOKINETICS
    38. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    39. 13.2 ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
    40. 14 CLINICAL STUDIES
    41. 16 HOW SUPPLIED/STORAGE AND HANDLING
    42. 17 PATIENT COUNSELING INFORMATION
    43. MEDICATION GUIDE
    44. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alprazolam Extended Release Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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.

Package Label.Principal Display Panel



Alprazolam ER 0.5mg (CIV) Tablet

Alprazolam ER 0.5mg (CIV) Tablet


* Please review the disclaimer below.