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Pyrophosphate Injection

Dosage Form: injection, powder, lyophilized, for solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Stannous Pyrophosphate

Dear Medical Professional,

Per your order, we have compounded Stannous-Pyrophosphate as a sterile lyophilized powder. The characteristics of this preparation are:

Pyrophosphate Injection Description

AnazaoHealth compounds Stannous-Pyrophosphate as a sterile lyophilized powder for the preparation of Tc99m Pyrophosphate. Each 10 ml reaction vial contains: 27.6 milligrams sodium pyrophosphate decahydrate, 3.5 milligrams stannous chloride, all lyophilized under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present

Indications and Usage for Pyrophosphate Injection

Stannous Pyrophosphate is indicated as a blood pool imaging agent which may be used for gated pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously, 15-30 minutes prior to intravenous administration of sodium pertechnetate Tc99m for in vivo red blood cell labeling, approximately 75 percent of the injected activity remains in the blood pool. The modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.

It is also indicated as a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.

Pyrophosphate Injection Dosage and Administration

The recommended adult dose of Tc99m Pyrophosphate Injection is:

  • 5 to 15 mCi for skeletal imaging
  • 10 to 15 mCi for cardiac imaging
  • one-third (0.33) to the entire vial contents, followed 15 to 20 mCi of sodium pertechnetate Tc 99m, for blood pool imaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

PYROPHOSPHATE 
Pyrophosphate Injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-218
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PYROPHOSPHATE (PYROPHOSPHORIC ACID) SODIUM PYROPHOSPHATE 27.6 mg
Inactive Ingredients
Ingredient Name Strength
STANNOUS CHLORIDE 3.5 mg
Packaging
# Item Code Package Description
1 NDC:51808-218-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (VIAL) in 1 KIT
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/23/2012
Labeler - AnazaoHealth Corporation (011038762)
Establishment
Name Address ID/FEI Operations
AnazaoHealth Corporation 011038762 MANUFACTURE(51808-218)
Revised: 05/2012
 
AnazaoHealth Corporation



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