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| Product Description: | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL — NDC 0338-1049-02 |
|---|---|
| Status: | Ongoing |
| City: | Deerfield |
| State: | IL |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide, Saudi Arabia and Colombia |
| Classification: | Class I |
| Product Quantity: | 49,932 glass containers |
| Reason For Recall: | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. |
| Recall Initiation Date: | 20131118 |
| Report Date: | 20140212 |
Nitroglycerin readily migrates into many plastics, including the polyvinyl chloride (PVC) plastics commonly used for intravenous administration sets. Nitroglycerin absorption by PVC tubing is increased when the tubing is long, the flow rates are low, and the nitroglycerin concentration of the solution is high. The delivered fraction of the solution’s original nitroglycerin content has been 20-60% in published studies using PVC tubing; the fraction varies with time during a single infusion, and no simple correction factor can be used. PVC tubing has been used in most published studies of intravenous nitroglycerin, but the reported doses have been calculated by simply multiplying the flow rate of the solution by the solution’s original concentration of nitroglycerin. The actual doses delivered have been less, sometimes much less, than those reported.
Relatively nonabsorptive intravenous administration sets are available. If intravenous nitroglycerin is administered through nonabsorptive tubing, doses based upon published reports will generally be too high.
Some in-line intravenous filters also absorb nitroglycerin; these filters should be avoided.
Solutions containing dextrose without electrolytes should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.
The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration and congested states of pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections.
There is currently no manufacturer warning information available for this drug.
Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and β-blockers; and for induction of intraoperative hypotension.
Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:
whose molecular formula is C3H5N3O9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.
Dextrose, USP is chemically designated D-glucose monohydrate C6H12O2 • H2O, a hexose sugar freely soluble in water whose structural formula is:
The molecular weight is 198.17.
Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless. Each mL of 100 mcg/mL Nitroglycerin in 5% Dextrose Injection contains nitroglycerin 100 mcg; propylene glycol 0.9 mg and dextrose, hydrous 50 mg in water for injection. May contain nitric acid for pH adjustment. The pH is 4.0 (3.0 to 6.5) and the calculated osmolarity is 265 mOsmol/L.*
Each mL of 200 mcg/mL Nitroglycerin in 5% Dextrose Injection contains nitroglycerin 200 mcg, propylene glycol 1.80 mg and dextrose, hydrous 50 mg in water for injection. May contain nitric acid for pH adjustment. The pH is 4.0 (3.0 to 6.5) and the calculated osmolarity is 277 mOsmol/L.*
Each mL of 400 mcg/mL Nitroglycerin in 5% Dextrose Injection contains nitroglycerin 400 mcg, propylene glycol 3.60 mg and dextrose, hydrous 50 mg in water for injection. May contain nitric acid for pH adjustment. The pH is 4.0 (3.0 to 6.5) and the calculated osmolarity is 301 mOsmol/L.*
*Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage.
Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not.
