NITROGLYCERIN, DEXTROSE
Drug Details
- Generic Name
- NITROGLYCERIN, DEXTROSE
- Brand Names
- NITROGLYCERIN IN DEXTROSE
- Application Number
- NDA019970
- Sponsor
- HF Acquisition Co LLC, DBA HealthFirst
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- NITROGLYCERIN
Indications and Usage
INDICATIONS & USAGE Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.
Warnings
WARNINGS Use of PVC (polyvinyl chloride) tubing in infusion sets may lead to loss of active ingredient due to adsorption of nitroglycerin to PVC tubing, therefore dosage is affected (see DOSAGE & ADMINISTRATION ). Nitroglycerin adsorption 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 non-adsorptive intravenous administration sets are available. If intravenous nitroglycerin is administered through non-adsorptive tubing, doses based upon published reports will generally be too high. Some in-line intravenous filters also adsorb 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.