Canada - English - Health Canada
(Nitroglycerin for Injection,USP)
For Intravenous Infusion
10 mg/10 mL
50 mg/10 mL
Omega Laboratories, Ltd.
11 177, Hamon
Control Number: 153511
Date of Revision:
June 26, 2012
(Nitroglycerin for Injection, USP)
For Intravenous Infusion
1 mg/mL (10 mg/10 mL)
5 mg/mL (50 mg/10 mL)
ARE AVAILABLE. THEY DIFFER IN CONCENTRATION AND/OR VOLUME PER
VIAL. WHEN SWITCHING FROM ONE PRODUCT TO ANOTHER ATTENTION
MUST BE PAID TO DILUTION AND TO THE DOSAGE AND ADMINISTRATION
ACTIONS AND CLINICAL PHARMACOLOGY
The principal pharmacological action of NITROJECT® (Nitroglycerin for Injection, USP) is the
relaxation of vascular smooth muscle. Nitrates probably act primarily by reducing oxygen
demand rather than increasing myocardial oxygen supply. Although venous effects predominate,
nitroglycerin produces, in a dose-related manner, dilatation of both arterial and venous beds.
Dilation of the postcapillary vessels, including large veins, promotes peripheral pooling of blood
(afterload). Left ventricular end diastolic pressure and volume are decreased, resulting in
reduction of ventricular wall tension results in a net decrease in myocardial oxygen consumption
(as measured by the pressure-rate product, tension time index and stroke work index). A
favorable net balance between myocardial oxygen supply and demand is achieved. Elevated
central venous and pulmonary capillary wedge pressures, pulmonary vascular resistance and
systemic vascular resistance are also reduced by nitroglycerin therapy.
Therapeutic doses of intravenous nitroglycerin reduce systolic, diastolic and mean arterial blood
pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if
blood pressure falls excessively or increased heart rate decreases the diastolic filling time.
Heart rate is usually slightly increased, presumably a reflex response to the fall in blood pressure.
Nitroglycerin is widely distributed in the body with an apparent volume of distribution of
approximately 200 litres in adult male subjects and is rapidly metabolized to dinitrates and
mononitrates, with a short half-life, estimated at 1 to 4 minutes. This results in a low plasma
concentration after intravenous infusion. At plasma concentrations of between 50 and 600
ng/mL, the binding of nitroglycerin to plasma proteins is approximately 60%, while those of the
metabolites 1,2-dinitroglycerin and 1,3-dinitroglycerin are 60% and 30% respectively. The
activity and half-life of 1,2-dinitroglycerin and 1,3-dinitroglycerin are not well characterized.
The mononitrate is not active.
NITROJECT® (Nitroglycerin for Injection, USP) is indicated for:
CONTROL OF BLOOD PRESSURE IN PERIOPERATIVE HYPERTENSION, i.e.,
hypertension associated with surgical procedures, especially cardiovascular procedures,
such as the hypertension seen during intratracheal intubation, anesthesia, skin incision,
sternotomy, cardiac bypass, and in the immediate postsurgical period.
CONGESTIVE HEART FAILURE ASSOCIATED WITH ACUTE MYOCARDIAL
recommended doses of conventional antianginal agents.
NITROJECT® (Nitroglycerin for Injection, USP) should not be administered to individuals
A known hypersensitivity to nitroglycerin or a known idiosyncratic reaction to organic
Hypotension or uncorrected hypovolemia, as the use of nitroglycerin for injection in such
states could produce severe hypotension or shock.
Increased intracranial pressure (e.g., head trauma or cerebral hemorrhage).
Constrictive pericarditis and pericardial tamponade.
CONTAINERS, THE DILUTION AND STORAGE OF NITROJECT® (NITROGLYCERIN
for INJECTION, USP) SHOULD BE MADE ONLY IN GLASS PARENTERAL SOLUTION
Some filters absorb nitroglycerin; therefore all filters should be avoided.
Important: Prior to the initiation of infusion check carefully which type of infusion set is going to
A conventional administration set with absorbable tubing (most frequently made of
polyvinyl chloride); or
A special administration set which will not absorb any significant amount of nitroglycerin
from the infusion solution.
Please read carefully points A and B below taking into account the highly significant difference
in the amount of nitroglycerin being delivered depending on the type (A or B) of the set used.
Forty to 80% of the total amount of nitroglycerin in the final diluted solution for infusion
is absorbed by polyvinyl chloride (PVC) intravenous administration sets. The higher rates of
absorption occur when flow rates are low, nitroglycerin concentrations are high, and the
administration set is long. Although the rate of loss is highest during the early phase of infusion
(when flow rates are lowest), the loss is neither constant nor self-limiting. Consequently, no
simple calculation or correction can be performed to convert the theoretical infusion rate (based
on the concentration of the infusion solution) to the actual delivery rate.
Because of this problem, special administration sets in which loss of nitroglycerin is
minimal have been developed. When these sets are used the calculated dose will be delivered,
because the loss of nitroglycerin due to absorption into the set will be negligible. Because the
tubing of such infusion sets may be less pliable than conventional PVC tubing, occlusion of the
infusion set by some pumps may not be complete. The result may be excessive flow at low
infusion rate settings, causing alarms, or unregulated gravity flow when the infusion pump is
stopped which could lead to over-infusion of nitroglycerin. To minimize the potential for such
occurrence, one should consider the following before using an infusion pump:
All infusion pumps should be tested with an appropriate infusion set to ensure their
ability to deliver nitroglycerin accurately at low flow rates, and to occlude the infusion
set properly when the infusion pump is stopped.
If the infusion pump alarms frequently, the tubing may be made more pliable by
manipulating and warming the tubing with your hands before installing the i.v. set into
To prevent the possibility of a runaway infusion, locate the set's roller clamp above the
pump unit, and use it to establish the approximate desired drip rate manually. Then insert
the infusion set into the unit, setting the unit at the desired drip rate. (It should be noted
that this procedure may be contrary to usually recommended procedures with some
In accordance with good operating practices, when turning off the pump, close the roller
clamp to assure complete occlusion.
Hospitals that use volumetric pumps for infusion of nitroglycerin should note that some
volumetric pumps require a special cassette or special integrated administration set with
disposal pump components made of assorted nitroglycerin-absorbing materials. If such
pump is used with the set connected from the bottle to the pump, you should be aware
that some loss of nitroglycerin will occur.
Additionally, care should be taken to fill the set drip chamber at least half full to prevent the
aspiration of air bubbles into the line during the fill cycle of the volumetric cassette.
As with all potent drugs, no matter what means for infusion of nitroglycerin is chosen, critical
care personnel must carefully monitor the patient's status. Due to variation in the responsiveness
hemodynamic function. Therefore, continuous monitoring of physiologic parameters (e.g. 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 blood pressure
and coronary perfusion pressure must be maintained.
DOSING INSTRUCTIONS MUST BE FOLLOWED WITH CARE. IT SHOULD BE NOTED
THAT WHEN SPECIAL NON-ABSORBING TYPE OF SET (TYPE B) IS USED THE
CALCULATED DOSE WILL BE DELIVERED TO THE PATIENT BECAUSE THE LOSS
OF NITROGLYCERIN DUE TO ABSORPTION IN STANDARD PVC TUBING WILL BE
PUBLISHED STUDIES UTILIZED GENERAL-USE PVC ADMINISTRATION SETS, AND
SPECIAL NON-ABSORBING TYPE OF SET (TYPE B) IS USED.
NITROJECT® (Nitroglycerin for Injection, USP) should be used with caution in patients who
have severe hepatic or renal disease.
cause sudden severe hypotension. Excessive
prolonged periods of time, must be avoided because of possible deleterious effects on the brain,
heart, liver and kidney from poor perfusion and the attendant risk of ischemia, thrombosis, and
altered function of these organs. Paradoxical bradycardia and increased angina pectoris may
accompany nitroglycerin-induced hypotension. Patients with depleted blood volumes such as
those with dehydration due to vomiting, diarrhea, or GI fluid loss, significant hemorrhage or
intensive diuretic therapy may be subject to hypotensive crises with i.v. nitroglycerin. The
hypovolemic state should be corrected prior to therapy to ensure that adequate ventricular filling
is maintained. Patients with normal or low pulmonary capillary wedge pressure are especially
sensitive to the hypotensive effects of intravenous nitroglycerin. If pulmonary capillary wedge
pressure is being monitored, it will be noted that a fall in wedge pressure precedes the onset of
arterial hypotension, and the pulmonary capillary wedge pressure is thus a useful guide to safe
titration of the drug.
Tolerance to nitroglycerin and cross tolerance to other nitrates may occur. Nitrate tolerance and
dependence in patients with chronic use of nitrates has been well documented. Tolerance to
nitroglycerin has been readily produced in animals and it was reported that even a single dose of
nitroglycerin in rats can produce some tolerance.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
No long term studies in animals were performed to evaluate the carcinogenic potential of
Animal reproduction studies have not been conducted with nitroglycerin. It is not known whether
nitroglycerin can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Nitroglycerin should be given to a pregnant woman only if clearly
It is not known whether nitroglycerin is excreted in human milk. Because many drugs are
administered to a nursing woman.
The safety and effectiveness of nitroglycerin in children have not been established.
Nitroglycerin prolongs pentobarbital sleep time. Nitroglycerin potentiates the hypotensive and
anticholinergic effects of tricyclic antidepressants. Patients receiving hypotensive agents and
nitroglycerin should be observed for possible additive hypotensive effect. If nitroglycerin is used
The most frequent adverse reaction in patients treated with NITROJECT® (Nitroglycerin for
Injection, USP) by intravenous infusion is headache, which occurs in approximately 14.5% of
patients. However, considerable variation in frequency is observed according to the indication
and dosage utilized. Symptomatic hypotension (2.7%) is the second most common adverse
reaction. Other adverse reactions occurring in less than 1% of patients are:
Reflex tachycardia, paradoxical increase of anginal pain, palpitations and
bradycardia may also occur, the incidence again depending on the indication and on the dosage
utilized. These effects can be reversed or minimized by discontinuing the drug or by carefully
adjusting the rate of infusion with constant hemodynamic monitoring of the patient.
Weakness, dizziness, apprehension and restlessness.
Nausea, vomiting, abdominal pain.
deficiencies or in congenital M hemoglobin variants (for treatment see Overdosage).
Muscle twitching and retrosternal discomfort.
The following additional adverse reactions have been reported with the oral and/or topical use of
nitroglycerin: cutaneous flushing, weakness, and occasionally drug rash or exfoliative dermatitis.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Symptoms of overdosage include headache, dizziness, flushing of skin, vomiting, marked fall in
blood pressure, methemoglobinemia and coma. Most of these effects can be obviated by
discontinuing the drug immediately. Reflex tachycardia can be treated by elevating the legs and
decreasing or temporarily terminating the infusion until the patient's condition stabilizes. Since
the duration of the hemodynamic effects following nitroglycerin administration is quite short,
additional corrective measures are usually not required.
However, if further therapy is indicated, administration of an intravenous alpha adrenergic
agonist (eg, methoxamine or phenylephrine) should be considered. Methemoglobinemia has been
reported following the use of nitroglycerin. The diagnosis of methemoglobinemia must be
considered in any cyanotic patient. Methylene blue 1-2 mg/kg as a 1% solution should be given
intravenously only if stupor or coma occurs.
DOSAGE AND ADMINISTRATION
Adequate facilities and personnel should be available for monitoring of the ECG and the blood
pressure. In addition, whenever possible, the pulmonary capillary wedge pressure should be
monitored to aid in the safe and effective infusion of nitroglycerin. Because of the rapid onset of
administered with the use of an infusion pump in order to allow precise measurement of the flow
BECAUSE OF THE LIKELY ALTERATIONS TO THE AMOUNT OF NITROGLYCERIN
DELIVERED TO THE PATIENT CAUSED BY ADMINISTRATION SETS, PUMPS, ETC.
AND THE GREAT VARIATIONS IN RESPONSIVENESS OF INDIVIDUAL PATIENTS TO
EACH PATIENT MUST BE TITRATED TO THE DESIRED LEVEL OF HEMODYNAMIC
FUNCTION (SEE WARNINGS).
NOT FOR DIRECT INTRAVENOUS INJECTION. NITROJECT® (NITROGLYCERIN for
INJECTION, USP IS A CONCENTRATED, POTENT DRUG WHICH MUST BE DILUTED
IN DEXTROSE (5%) INJECTION, USP, OR SODIUM CHLORIDE (0.9%) INJECTION, USP,
PRIOR TO ITS INFUSION. THE RESULTANT SOLUTION SHOULD BE USED WITHIN 24
ADMIXED WITH OTHER DRUGS.
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.
Dosage is affected by the type of infusion set used (see WARNINGS). Although the usual
starting adult dose range reported in clinical studies was 25 µg/min or more, those studies used
The recommended dosage should initially be 5 µg/min delivered through an infusion pump
capable of exact and constant delivery of the drug, such as a properly calibrated peristaltic-action
pump which has been checked to determine proper operation with the appropriate infusion set.
Subsequent titration must be adjusted to the clinical situation, with dose increments becoming
more cautious as partial response is seen. Initial titration should be 5 µg/min increments, with
increases every 3 to 5 minutes until some response is noted. If no response is seen at 20 µg/min,
increments of 10 and later 20 µg/min can be used. Once a partial blood pressure response is
observed, the rate of dose increase should be reduced and the interval between increments should
Patients with normal or low left ventricular filling pressure 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 µg/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 (blood pressure and heart
appropriate) MUST BE PERFORMED to achieve the correct dose. Adequate systemic blood
pressure and coronary perfusion pressure must be maintained.
Nitroject® I.V. ADMINISTRATION TABLE
NITROJECT® 1 mg/mL
EACH 10 mL VIAL = 10 mg NITROGLYCERIN
10 mL in 250 mL
20 mL in 250 mL
30 mL in 250 mL
40 µg/mL (approx.)
75 µg/mL (approx.)
110 µg/mL (approx.)
(60 microdrops=1 mL)
Nitroject® I.V. ADMINISTRATION TABLE
NITROJECT® 5 mg/mL
EACH 10 mL VIAL = 50 mg NITROGLYCERIN
10 mL in 1000 mL
10 mL in 500 mL
20 mL in 1000 mL
10 mL in 250 mL
20 mL in 500 mL
40 mL in 1000 mL
50 µg/mL (approx.)
200 µg/mL (approx.)
(60 microdrops=1 mL)
Invert the glass parenteral bottle several times following admixture to ensure uniform dilution of
NITROJECT® IV. As with all intravenous admixtures, dilution should be made just prior to
administration and the solution used within 24 hours.
NOTE: If the concentration is adjusted, it is imperative to flush or replace the nitroglycerin
infusion set before a new concentration is utilized. Depending on the length of the dead space
and the flow rate, the time required for the new concentration to reach the patient may vary (e.g.
if the dead space of the set is approximately 15 mL and depending on the flow rate, it could take
from 9 minutes to 3 hours for the new concentration to reach the patient if the set has not been
flushed or replaced).
A colourless, slightly volatile, odourless, oily liquid, with a sweet,
aromatic and pungent taste.
1 g in 800 mL of water, 1 g in 4 g of alcohol, 1 g in 18 g methanol,
1 g in 120 g of carbon disulphide, and 1 g in 6 g of almond oil;
miscible with acetone, chloroform, ether glacial acetic acid, ethyl
dichloroethylene; sparingly soluble in glycerol and light petroleum.
Crystallizes in 2 forms: labile form, mp + 2.8°C; stable form, mp +
NITROJECT® 1 mg/mL (Nitroglycerin for Injection, USP) is a clear, colorless solution for
intravenous infusion after dilution. Each mL contains 1.0 mg of nitroglycerin, 10% ethanol v/v
and Water for Injection, USP, q.s. to 1 mL.
NITROJECT® 5 mg/mL (Nitroglycerin for Injection, USP) is a clear, colorless solution for
intravenous infusion after dilution. Each mL contains 5.0 mg of nitroglycerin, 30% ethanol v/v,
30% propylene glycol v/v and Water for Injection, USP, q.s. to 1 mL.
These solutions are sterile, non-pyrogenic and non-explosive.
Stability and storage recommendations:
Store between 15 and 30°C. Protect from freezing. Protect from light.
Under these storage conditions NITROJECT® 1 mg/mL (Nitroglycerin for Injection, USP) is
stable for 18 months.
Under these storage conditions NITROJECT® 5 mg/mL (Nitroglycerin for Injection, USP) is
stable for 36 months.
SOLUTION PREPARATION FOR AN INFUSION PUMP
Aseptically transfer 10 mL (10 mg nitroglycerin) of NITROJECT® 1 mg/mL (Nitroglycerin for
Injection, USP) into a glass, IV bottle containing 250 mL of 5% Dextrose Injection, USP or 0.9%
Sodium Chloride Injection, USP, and mix well. The resultant solution will contain approximately
40 µg/mL of nitroglycerin and is stable for at least 24 hours at controlled room temperature (15
to 30°C). For other concentrations, refer to Table. Invert the glass parenteral bottle several times
following admixture to assure uniform dilution.
STABILITY AND STORAGE OF DILUTED SOLUTION
The diluted NITROJECT® (Nitroglycerin for Injection, USP) is stable for at least 24 hours at
controlled room temperature (15 to 30°C). Discard all unused solution after 24 hours.
NITROJECT® (Nitroglycerin for Injection, USP) is incompatible with alkalies. Nitroglycerin
readily migrates into many plastics (see WARNINGS). Some filters also absorb nitroglycerin
and should be avoided. Forty to 80% of the total amount of nitroglycerin in the final diluted
solution for infusion is absorbed by polyvinyl chloride (PVC) intravenous administration sets
NITROJECT® 1 mg/mL (Nitroglycerin for Injection, USP) is available in 10 mL single-dose
vials containing 10 mg of nitroglycerin. Each mL contains 1 mg of nitroglycerin. Boxes of 5 x 10
NITROJECT® 5 mg/mL (Nitroglycerin for Injection, USP) is available in 10 mL single-dose
vials containing 50 mg of nitroglycerin. Each mL contains 5 mg of nitroglycerin. Boxes of 5 x 10
The NITROJECT® dosage forms consist of concentrated solutions of nitroglycerin which
in Dextrose (5%) Injection, USP, or Sodium Chloride (0.9%) Injection, USP, prior to
It has been shown that intravenous nitroglycerin in anesthetized dogs produced a significant
dilation of the large coronary arteries. Similarly, a marked dilation of large coronary arteries was
observed in conscious dogs although only a slight effect was seen in the small coronary arteries.
Nitroglycerin caused a decrease in the ST segment elevations which accompany myocardial
ischemia when administered intravenously to dogs with occluded coronary arteries. Although
coronary blood flow was increased by 45% in the subendocardium of the ischemic areas,
prolonged i.v. administration of nitroglycerin did not decrease the size of the infarct.
predominated over the arterioles. In anesthetized dogs, nitroglycerin decreased mean arterial
pressure due to vasodilation of peripheral arteries.
Studies on blood flow in the human forearm have demonstrated a significant decrease in venous
tone after sublingual administration of nitroglycerin. This caused a pooling of blood in the
peripheral veins and a decrease in venous return to the heart. A slight decrease in systemic
arterial pressure was observed with a corresponding fall in vascular resistance in the forearm.
Administration of nitroglycerin reduced towards normal left ventricular end diastolic pressure
which has been found to be markedly elevated in patients with coronary artery disease. The
result was disappearance of anginal pain. Intravenous nitroglycerin given to patients with
congestive heart failure produced a significant decrease in pulmonary capillary wedge pressure
and an improvement of the cardiac index.
Nitroglycerin shows essentially single compartment kinetics in rats when administered by the
distribution phase, followed by rapid metabolism with a half-life of about 4 minutes.
In animal studies, nitroglycerin was rapidly degraded in the liver by glutathione-organic nitrate
reductase. The metabolites are 1,3 or 1,2-glyceryl dinitrate, 1 or 2-glyceryl-mononitrate and
Elimination was by the urine, feces and expired air.
The acute intravenous toxicity in various species is summarized below:
Lethal doses of nitroglycerin in common laboratory animals by other routes of administration
ranged from 80 to 500 mg/kg.
Signs of toxicity included methemoglobinemia and circulatory collapse, leading to convulsions
It has been reported that most cats receiving 7.5 or 15 mg/kg, subcutaneously, survived 50 daily
doses. Albuminuria and icterus were noted in the animals; and, at sacrifice, hemorrhage of the
cerebellum, heart, liver and spleen were observed. Cats exposed to saturated atmospheres of
nitroglycerin for 68 days developed anemia and moderate leucocytosis. Longer exposures
accompanying fall in blood pressure were produced.
Anjou-Lindskog E, Broman L, Holmgren A: Effects of nitroglycerin on central
haemodynamics and V A/Q distribution early after coronary bypass surgery. Acta
Anaesth Scand 26: 489-497, 1982.
Armstrong PW, Walker DC, et al: Vasodilator therapy in acute myocardial infarction:
A comparison of sodium nitroprusside and nitroglycerin. Circulation 52: 1118-1122,
Armstrong PW, Watts DG, Moffat JA: Steady state pharmacokinetic haemodynamic
studies of intravenous nitroglycerin in congestive cardiac failure. Brit J Clin Pharmac
16: 385-390, 1983.
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d'oxygène myocardique chez le coronarien. Nouv Press Méd 8 (4):250-256, 1979.
Baaske DM, Amann AH, et al: Nitroglycerin compatibility with intravenous fluid
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Bale R, Powles A, Wyatt R: I.V. glyceryl trinitate: haemodynamic effects and clinical
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Barnes CD, Eltherington LG: Nitroglycerol, in: Barnes CD, Eltherington LG (Eds):
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Bayley S, Valentine H, Bennett ED: The haemodynamic responses to incremental
doses of intravenous nitroglycerin in left ventricular failure. Intensive Care Med 10
(3): 139-145, 1984.
Bjoraker DG, Knight PR: Intravenous nitroglycerin administration during infrarenal
aortic clamping. Can Anaesth Soc J 31 (1):44-50, 1984.
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Chestnut JS, Albin MS, et al: Clinical evaluation of intravenous nitroglycerin for
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Cottrell JE, Turndorf H: Intravenous nitroglycerin. Am Heart J 96 (4):550-553, 1978.
Di Carlo FJ: Nitroglycerin revisited: Chemistry, biochemistry, interactions. Drug
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Fibuch EE, Cecil WT, Reed WA: Methemoglobinemia associated with organic nitrate
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Flaherty JT, Becker LC, et al: A randomized clinical trial of intravenous nitroglycerin
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Flaherty JT, Come PC, et al: Effect of intravenous nitroglycerin on left ventricular
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Macho P, Vatner SF: Effects of nitroglycerin and nitroprusside on large and small
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Sethna DH, Moffitt EA, et al: Intravenous nitroglycerin and myocardial metabolism
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