Label: P32 SODIUM PHOSPHATE injection, suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 19, 2012

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  • DESCRIPTION

    AnazaoHealth’s compounded P32 Chromic Phosphate is supplied as a sterile, nonpyrogenic aqueous solution. It contains 30 % dextrose solution, 1 mg sodium acetate, 2 % benzyl alcohol added as a preservative. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.

  • INDICATIONS AND USAGE

    P32 chromic phosphate is indicated for intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease, and may be injected interstitially for the treatment of cancer. It is also used in hemophilia patients for intraarticular injections.

    Mechanism of Action

    Radioactive phosphorous works by local irradiation by beta emission.

  • CONTRAINDICATIONS

    P32 sodium phosphate should not be used in the presence of ulcerative tumors.

  • WARNINGS

    Not for intravascular injection.

  • DOSAGE AND ADMINISTRATION

    Shake the vial well before injection.

    For intraperitoneal instillation, administer 10-20 mCi

    For intrapleural instillation, administer 6 to 12 mCi

    Doses for interstitial use should be based on estimated gram weight of tumor, about 0.1 to 0.5 mCi/gm.

  • DECAY CHART

    5ed86373-figure-01
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

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  • INGREDIENTS AND APPEARANCE
    P32 SODIUM PHOSPHATE 
    p32 sodium phosphate injection, suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-127
    Route of AdministrationINTRA-ARTICULAR, INTRAPERITONEAL, INTERSTITIAL, INTRAPLEURAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHOSPHORUS P-32 (UNII: 690284A407) (PHOSPHORUS P-32 - UNII:690284A407) PHOSPHORUS P-325 mCi  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2) 0.3 g  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.02 mL  in 1 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) 1 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-127-013 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/19/2012
    Labeler - AnazaoHealth Corporation (011038762)
    Establishment
    NameAddressID/FEIBusiness Operations
    AnazaoHealth Corporation011038762MANUFACTURE(51808-127)
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