DIPYRIDAMOLE - dipridamole solution 
AnazaoHealth Corporation

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.

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DIPYRIDAMOLE

Dear Medical Professional,

Per your order, we have compounded Dipyridamole as 12 mL in a 10 mL vial. The characteristics of this preparation are described below

DESCRIPTION

AnazaoHealth’s compounded Dipyridamole vial is a sterile, non-pyrogenic preparation that is 5mg/mL. This vial contains no antimicrobial preservative

INDICATIONS AND USAGE

Dipyridamole is a coronary vasodilator and is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately

DOSAGE AND ADMINISTRATION

The recommended dose is 0.142 mg/kg/minute (0.57 mg/kg total) or 0.568 mg/kg or 60 mg total dose infused over 4 minutes. Although the maximum tolerated dose has not been determined, clinical experience suggests that a total dose beyond 60 mg is not needed for any patient.

Prior to intravenous administration, dipyridamole should be diluted in at least a 1:2 ratio with 0.45% sodium chloride injection, 0.9% sodium chloride injection, or 5% dextrose injection for a total volume of approximately 20 to 50 mL. Infusion of undiluted dipyridamole injection may cause local irritation.

Myocardial perfusion assessment should be started when maximal vasodilation is reached, usually after 3 minutes, which generally occurs approximately 7 minutes from onset of infusion

ADVERSE REACTIONS

Flushing, chest pain, dyspnea, headache, dizziness, nausea, vomiting, palpitations, arm/back/shoulder pain, arrhythmias, paresthesias, pulmonary edema, asystole myocardial infarcation

Side effects can be easily reversed by an administration of an IV bolus of 50-75 mg of Aminophylline or an infusion of 250-500 mg over 20 minutes

CONTRAINDICATIONS

Theophylline therapy, active wheezing, high grade antroventricular block

Storage and Handling

Dipyridamole should be stored at room temperature and protected from light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

C:\Users\achai\Desktop\NDC Project-AC 2012\Dipyridamole\Labeldipy.JPG
DIPYRIDAMOLE 
dipridamole solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-204
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51808-204-0110 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/23/2012
Labeler - AnazaoHealth Corporation (011038762)
Establishment
NameAddressID/FEIBusiness Operations
AnazaoHealth Corporation011038762MANUFACTURE

Revised: 5/2012
Document Id: 71f96ee3-a363-4345-9ab6-5270ae323fab
Set id: c76c3c6f-c3e0-4e35-ab01-5468585e0d9d
Version: 2
Effective Time: 20120523
 
AnazaoHealth Corporation