Label: DIPYRIDAMOLE- dipridamole solution
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated May 23, 2012
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- INDICATIONS AND USAGE
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
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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-204 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-204-01 10 mL in 1 VIAL 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 Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE