FDA Label for Medroxyprogesterone Acetate

View Indications, Usage & Precautions

    1. WARNING: LOSS OF BONE MINERAL DENSITY
    2. 1    INDICATIONS AND USAGE
    3. 2.1 PREVENTION OF PREGNANCY
    4. 2.2 SWITCHING FROM OTHER METHODS OF CONTRACEPTION
    5. 3    DOSAGE FORMS AND STRENGTHS
    6. 4    CONTRAINDICATIONS
    7. 5.1 LOSS OF BONE MINERAL DENSITY
    8. 5.2 THROMBOEMBOLIC DISORDERS
    9. 5.3 CANCER RISKS
    10. 5.4 ECTOPIC PREGNANCY
    11. 5.5 ANAPHYLAXIS AND ANAPHYLACTOID REACTION
    12. 5.6 INJECTION SITE REACTIONS
    13. 5.7 LIVER FUNCTION
    14. 5.8 CONVULSIONS
    15. 5.9 DEPRESSION
    16. 5.10 BLEEDING IRREGULARITIES
    17. 5.11 WEIGHT GAIN
    18. 5.12 CARBOHYDRATE METABOLISM
    19. 5.13 FLUID RETENTION
    20. 5.14 RETURN OF FERTILITY
    21. 5.15 SEXUALLY TRANSMITTED INFECTIONS
    22. 5.16 MONITORING
    23. 5.17 INTERFERENCE WITH LABORATORY TESTS
    24. 6    ADVERSE REACTIONS
    25. 6.1 CLINICAL TRIALS EXPERIENCE
    26. 6.2 POST-MARKETING EXPERIENCE
    27. 7.1 CHANGES IN CONTRACEPTIVE EFFECTIVENESS ASSOCIATED WITH CO-ADMINISTRATION OF OTHER PRODUCTS
    28. 7.2 LABORATORY TEST INTERACTIONS
    29. 8.1 PREGNANCY
    30. 8.2 LACTATION
    31. 8.3 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
    32. 8.4 PEDIATRIC USE
    33. 8.5 GERIATRIC USE
    34. 11 DESCRIPTION
    35. 12.1 MECHANISM OF ACTION
    36. 12.2 PHARMACODYNAMICS
    37. 12.3 PHARMACOKINETICS
    38. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    39. 14.1 CONTRACEPTION
    40. 14.2 BONE MINERAL DENSITY CHANGES IN WOMEN TREATED WITH MEDROXYPROGESTERONE ACETATE
    41. 14.3 BONE MINERAL DENSITY CHANGES IN ADOLESCENT FEMALES (12 TO 18 YEARS OF AGE) TREATED WITH MEDROXYPROGESTERONE ACETATE
    42. 14.4 BONE FRACTURE INCIDENCE IN WOMEN TREATED WITH MEDROXYPROGESTERONE ACETATE
    43. 15 REFERENCES
    44. 16 HOW SUPPLIED/STORAGE AND HANDLING
    45. 17 PATIENT COUNSELING INFORMATION
    46. PATIENT INFORMATION
    47. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Medroxyprogesterone Acetate Product Label

The following document was submitted to the FDA by the labeler of this product Amneal Pharmaceuticals Ny 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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