FDA Label for Dipyridamole

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

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