|Manufacturer:||American Regent Laboratories|
Nitroglycerin Injection is supplied in 5 mg/mL solution.
A dilution and administration scheme for Nitroglycerin Injection is shown in Table 1 below.TABLE 1 60 MICRODROPS = 1 mL SolutionConcentration (mcg/mL)100200400 Dose (mcg/min)FLOW RATE (microdrops/min = mL/hr) 53—— 1063— 159—— 201263 30189— 4024126 6036189 80482412 120723618 160964824 240—7236 320—9648 480——72 640——96 NITROGLYCERIN INJECTION DILUTION TABLE (Diluent: Dextrose 5% Injection or Sodium Chloride Injection (0.9%)) Each mL of Nitroglycerin Injection contains 5 mg of nitroglycerin.
Total Contents:Each 5 mL vial contains 25 mg of nitroglycerin. Each 10 mL vial contains 50 mg of nitroglycerin. mL of Nitroglycerin InjectionmgFinal Concentration 100 mcg/mL200 mcg/mL400 mcg/mL Volumeq.s.
toq.s.to 5 mL25 mg250 mL125 mL- - - 10 mL50 mg500 mL250 mL125 mL 20 mL100 mg1000 mL500 mL250 mL 40 mL200 mg- - -1000 mL500 mL NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Allergic reactions to organic nitrates are extremely rare, but they do occur.
Nitroglycerin Injection is contraindicated in patients who are allergic to it.In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venous return.Intravenous nitroglycerin is contraindicated in patients with these conditions.
Amplification of the vasodilatory effects of nitroglycerin by sildenafil can result in severe hypotension.
The time course and dose dependence of this interaction have not been studied.
Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with volume expansion.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.Some in-line intravenous filters also absorb nitroglycerin; these filters should be avoided.Because of the problem of nitroglycerin absorption by polyvinyl chloride (PVC) tubing, Nitroglycerin Injection should be used with the least absorptive infusion tubing (i.e., non-PVC tubing) available.DOSING INSTRUCTIONS MUST BE FOLLOWED WITH CARE.
WHEN THE APPROPRIATE INFUSION SETS ARE USED, THE CALCULATED DOSE WILL BE DELIVERED TO THE PATIENT, BECAUSE THE LOSS OF NITROGLYCERIN INJECTION SEEN WITH STANDARD PVC TUBING WILL BE AVOIDED.THE DOSAGES REPORTED IN PUBLISHED STUDIES UTILIZED GENERAL-USE PVC ADMINISTRATION SETS, AND RECOMMENDED DOSES BASED ON THIS EXPERIENCE WILL BE TOO HIGH WHEN THE LOW-ABSORBING INFUSION SETS ARE USED.