Nitroglycerin intravenous

FDA label, American Regent, Inc., intravenous, effective 2021-07-22. Full label on DailyMed

Other products: Nitroglycerin, Nitroglycerin transdermal

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Nitrate Vasodilator

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Preparation and administration

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DOSAGE AND ADMINISTRATION NOT FOR DIRECT INTRAVENOUS INJECTION NITROGLYCERIN INJECTION IS A CONCENTRATED, POTENT DRUG WHICH MUST BE DILUTED IN DEXTROSE (5%) INJECTION OR SODIUM CHLORIDE (0.9%) INJECTION PRIOR TO ITS INFUSION. NITROGLYCERIN INJECTION SHOULD NOT BE MIXED WITH OTHER DRUGS. Initial Dilution: Aseptically transfer the contents of one nitroglycerin vial (50 mg of nitroglycerin) into a 500 mL glass bottle of either Dextrose (5%) Injection or Sodium Chloride Injection (0.9%).

This yields a final concentration of 100 mcg/mL. Diluting 5 mg nitroglycerin into 100 mL will yield a final concentration of 50 mcg/mL. Maintenance Dilution: It is important to consider the fluid requirements of the patient as well as the expected duration of infusion in selecting the appropriate dilution of Nitroglycerin Injection.

After the initial dosage titration, the concentration of the solution may be increased, if necessary, to limit fluids given to the patient. The nitroglycerin concentration should not exceed 400 mcg/mL. See chart. Note: If the concentration is adjusted, it is imperative to flush or replace the infusion set before a new concentration is utilized.

If the set were not flushed or replaced, it could take minutes to hours, depending upon the flow rate and the dead space of the set, for the new concentration to reach the patient. Invert the glass parenteral bottle several times to assure uniform dilution of the nitroglycerin. Dosage is affected by the type of container and administration set used.

See WARNINGS . Although the usual starting adult dose range reported in clinical studies was 25 mcg/min or more, these studies used PVC administration sets. THE USE OF NON-ABSORBING TUBING WILL RESULT IN THE NEED FOR REDUCED DOSES. If a peristaltic action infusion pump is used, an appropriate administration set should be selected with a drip chamber that delivers approximately 60 microdrops/mL.

Table 1 and the Nitroglycerin Injection Dilution Table below may be used to calculate the nitroglycerin dilution and flow rate in microdrops/minute to achieve the desired Nitroglycerin Injection administration rate. If a volumetric infusion pump is used, an appropriate volumetric infusion pump connector set should be selected.

Table 1 below may still be used; however, flow rate will be determined directly by the infusion pump, independent of the drop size of the appropriate set drip chambers. Thus, the reference to ``microdrops/min′′ is not applicable, and the corresponding flow rate in mL/hr should be used to determine pump settings. When using a non-absorbing infusion set, the initial dosage should be 5 mcg/min delivered through an infusion pump capable of exact and constant delivery of the drug.

Adequate systemic blood pressure and coronary perfusion pressure must be maintained. Dilution: Nitroglycerin Injection is supplied in 5 mg/mL solution. A dilution and administration scheme for Nitroglycerin Injection is shown in Table 1 below. [See table below.] 48 24 240 — 72 36 320 — 96 48 480 — — 72 640 — — 96 [See table below.] 250 mL 125 mL 20 mL 100 mg 1000 mL 500 mL 250 mL 40 mL 200 mg - - - 1000 mL 500 mL NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

TABLE 1
60 MICRODROPS = 1 mL
Solution Concentration (mcg/mL) 100 200 400
Dose (mcg/min) FLOW RATE (microdrops/min = mL/hr)
5 3 — —
10 6 3 —
15 9 — —
20 12 6 3
30 18 9 —
40 24 12 6
60 36 18 9
80 48 24 12
120 72 36 18
160 96 48 24
240 — 72 36
320 — 96 48
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 10 mL vial contains 50 mg of nitroglycerin.
mL of Nitroglycerin Injection mg Final Concentration
100 mcg/mL 200 mcg/mL 400 mcg/mL
Volume q.s. to q.s. to q.s. to
5 mL 25 mg 250 mL 125 mL - - -
10 mL 50 mg 500 mL 250 mL 125 mL
20 mL 100 mg 1000 mL 500 mL 250 mL
40 mL 200 mg - - - 1000 mL 500 mL

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  • Nitroglycerin intravenous
Label text (1 paragraph)

Drug Interactions: The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Administration of nitroglycerin infusions through the same infusion set as blood can result in pseudoagglutination and hemolysis. More generally, nitroglycerin in 5% dextrose or sodium chloride 0.9% should not be mixed with any other medication of any kind. Intravenous nitroglycerin interferes, at least in some patients, with the anticoagulant effect of heparin. In patients receiving intravenous nitroglycerin, concomitant heparin therapy should be guided by frequent measurement of the activated partial thromboplastin time.

Contraindications

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.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for nitroglycerin intravenous. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy: Pregnancy Category C: Animal teratology studies have not been conducted with nitroglycerin injection. Teratology studies in rats and rabbits, however, were conducted with topically applied nitroglycerin ointment at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on dams or fetuses were seen at any dose tested. There are no adequate and well-controlled studies in pregnant women. Nitroglycerin should be given to a pregnant woman only if clearly needed.

Lactation

Nursing Mothers: It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.

Breastfeeding (LactMed)

Topical use of nitroglycerin for anal fissures by nursing mothers appears to have no adverse effects on their breastfed infants. Topical use on the nipples has been used for alleviation of Raynaud phenomenon of the nipples, but only after cessation of breastfeeding. Nitroglycerin should not be used topically on the nipples during breastfeeding. Sublingual and intravenous nitroglycerin have not been studied during breastfeeding. Observe infants for flushing and discomfort after breastfeeding.

Source: LactMed: Nitroglycerin (NICHD, public domain)Revised Oct 15, 2024

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