Nitroglycerin

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Nitroglycerin Recall

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Blair Pearl

I was advised to take this medication sublingually (let it dissolve under my tongue), which REALLY burns. It does relieve my chest pain when I take it, but it also makes me feel tired and dehydrated, like I drank too much alcohol the night before.

posted on October 26, 2015

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Side Effects & Adverse Reactions

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.

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Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Nitroglycerin 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.

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History

There is currently no drug history available for this drug.

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Other Information

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:

whose empiric formula is C3H5N3O9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.

Nitroglycerin Injection, USP is a clear, practically colorless additive solution for intravenous infusion after dilution. Each mL contains: Nitroglycerin 5 mg, Alcohol 30% (v/v), Propylene Glycol 30%, and Water for Injection q.s. pH (range 3.0 to 6.5) may have been adjusted with Sodium Hydroxide and/or Hydrochloric Acid.

The solution is sterile, non-pyrogenic, and nonexplosive.

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Nitroglycerin Manufacturers

Cardinal Health

Nitroglycerin | Cardinal Health

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.
1. 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. 2. 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. Subsequent titration must be adjusted to the clinical situation, with dose increments becoming more cautious as partial response is seen. Initial titration should be in 5 mcg/min increments, with increases every 3-5 minutes until some response is noted. If no response is seen at 20 mcg/min, increments of 10 and later 20 mcg/min can be used. Once a partial blood pressure response is observed, the dose increase should be reduced and the interval between increases should be lengthened.
Some patients with normal or low left ventricular filling pressures or pulmonary capillary wedge pressure (e.g., angina patients without other complications) may be hypersensitive to the effects of nitroglycerin and may respond fully to doses as small as 5 mcg/min. These patients require especially careful titration and monitoring.
There is no fixed optimum dose of nitroglycerin. Due to variations in the responsiveness of individual patients to the drug, each patient must be titrated to the desired level of hemodynamic function. Therefore, continuous monitoring of physiologic parameters (i.e., blood pressure and heart rate in all patients, other measurements such as pulmonary capillary wedge pressure, as appropriate) MUST be performed to achieve the correct dose. 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.
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
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

No Recall
Greenstone Llc

Nitroglycerin | Greenstone Llc

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitroglycerin tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.

No Recall
Physicians Total Care, Inc.

Nitroglycerin | Physicians Total Care, Inc.

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitroglycerin tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.

No Recall
Rebel Distributors Corp

Nitroglycerin | Rebel Distributors Corp

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every five minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitroglycerin tablets USP may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.

No Recall
American Regent, Inc.

Nitroglycerin | American Regent, Inc.

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. Subsequent titration must be adjusted to the clinical situation, with dose increments becoming more cautious as partial response is seen. Initial titration should be in 5 mcg/min increments, with increases every 3-5 minutes until some response is noted. If no response is seen at 20 mcg/min, increments of 10 and later 20 mcg/min can be used. Once a partial blood pressure response is observed, the dose increase should be reduced and the interval between increases should be lengthened.
Some patients with normal or low left ventricular filling pressures or pulmonary capillary wedge pressure (e.g., angina patients without other complications) may be hypersensitive to the effects of nitroglycerin and may respond fully to doses as small as 5 mcg/min. These patients require especially careful titration and monitoring.
There is no fixed optimum dose of nitroglycerin. Due to variations in the responsiveness of individual patients to the drug, each patient must be titrated to the desired level of hemodynamic function. Therefore, continuous monitoring of physiologic parameters (i.e., blood pressure and heart rate in all patients, other measurements such as pulmonary capillary wedge pressure, as appropriate) MUST be performed to achieve the correct dose. 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.
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
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

No Recall
Preferred Pharmaceuticals, Inc

Nitroglycerin | Preferred Pharmaceuticals, Inc

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every five minutes, until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitroglycerin tablets USP may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.
During administration the patient should rest, preferably in the sitting position.
No dosage adjustment is required in patients with renal failure.

No Recall
General Injectables And Vaccines, Inc.

Nitroglycerin | General Injectables And Vaccines, Inc.

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.

1. Initial Dilution:
Aseptically transfer the contents of one nitroglycerin vial (containing 25 mg or 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 50 mcg/mL or 100 mcg/mL. Diluting 5 mg nitroglycerin into 100 mL will also yield a final concentration of 50 mcg/mL.
2. 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. Subsequent titration must be adjusted to the clinical situation, with dose increments becoming more cautious as partial response is seen. Initial titration should be in 5 mcg/min increments, with increases every 3-5 minutes until some response is noted. If no response is seen at 20 mcg/min, increments of 10 and later 20 mcg/min can be used. Once a partial blood pressure response is observed, the dose increase should be reduced and the interval between increases should be lengthened. Some patients with normal or low left ventricular filling pressures or pulmonary capillary wedge pressure (e.g., angina patients without other complications) may be hypersensitive to the effects of nitroglycerin and may respond fully to doses as small as 5 mcg/ min. These patients require especially careful titration and monitoring. There is no fixed optimum dose of nitroglycerin. Due to variations in the responsiveness of individual patients to the drug, each patient must be titrated to the desired level of hemodynamic function. Therefore, continuous monitoring of physiologic parameters (i.e., blood pressure and heart rate in all patients, other measurements such as pulmonary capillary wedge pressure, as appropriate) MUST be performed to achieve the correct dose. 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.
60 MICRODROPS=1mL

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
60MICRODROPS=1 mL
NITROGLYCERIN INJECTION DILUTION TABLE
Each mL of Nitroglycerin Injection contains 5 mg of nitroglycerin.
Total Contents: Each 10 mL vial contains 50 mg of nitroglycerin.

FINAL CONCENTRATION
mL of
Nitroglycerin
Injection

Volume mg 100 mcg/mL

q.s. to 200 mcg/mL

q.s. to 400 mcg/mL

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
(Diluent: Dectrose 5% Injection of Sodium Chloride Injection (0.9%)

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

No Recall