Nitroglycerin (Nitroglycerin) - Summary

NITROGLYCERIN SUMMARY

NITROGLYCERIN
Transdermal System
RX ONLY

FOR INTRAVENOUS USE ONLY. NOT FOR DIRECT INTRAVENOUS INJECTION. NITROGLYCERIN INJECTION, USP MUST BE DILUTED IN 5% DEXTROSE INJECTION, USP, OR 0.9% SODIUM CHLORIDE INJECTION, USP PRIOR TO ITS INFUSION (SEE DOSAGE AND ADMINISTRATION SECTION). THE ADMINISTRATION SET USED FOR INFUSION WILL AFFECT THE AMOUNT OF NITROGLYCERIN DELIVERED TO THE PATIENT (SEE WARNINGS, AND DOSAGE AND ADMINISTRATION SECTIONS).

CAUTION: SEVERAL PREPARATIONS OF NITROGLYCERIN FOR INJECTION ARE AVAILABLE. THEY DIFFER IN CONCENTRATION AND/OR VOLUME PER VIAL. WHEN SWITCHING FROM ONE PRODUCT TO ANOTHER ATTENTION MUST BE PAID TO THE DILUTION AND DOSAGE AND ADMINISTRATION INSTRUCTIONS.

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate.

Nitroglycerin Injection, USP is indicated for treatment of perioperative 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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NEWS HIGHLIGHTS

Published Studies Related to Nitroglycerin

Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. [2009.09]
OBJECTIVE: To estimate whether treatment with intravenous nitroglycerin for uterine relaxation increases the chance of successful external cephalic version... CONCLUSION: Treatment with intravenous nitroglycerin increased the rate of successful external cephalic version in nulliparous, but not in multiparous, women. Treatment with intravenous nitroglycerin appeared to be safe, but our numbers were too small to rule out rare serious adverse effects. LEVEL OF EVIDENCE: I.

Transdermal nitroglycerin therapy may not prevent early postmenopausal bone loss. [2009.09]
CONTEXT: Osteoporosis is common among postmenopausal women; animal studies and human pilot studies support the concept of nitric oxide (NO) donors reducing bone mineral density loss. OBJECTIVE: The objective of the study was to evaluate whether NO donor, nitroglycerin, prevents postmenopausal bone loss... CONCLUSIONS: BMD changes did not substantially differ between postmenopausal women who received the dose of nitroglycerin tested, in comparison with a placebo. Once-daily dosing with 22.5 mg of transdermal-administered nitroglycerin was not effective (compliance adjusted dose was only approximately 16 mg/d); a sub-therapeutic dose.

Effects of nitroglycerin on sublingual microcirculatory blood flow in patients with severe sepsis/septic shock after a strict resuscitation protocol: A double-blind randomized placebo controlled trial. [2009.08.27]
OBJECTIVES:: Microcirculatory alterations have been associated with morbidity and mortality in human sepsis. Such alterations occur despite pressure-guided resuscitation. Earlier data suggested that impaired microcirculatory blood flow could be corrected with intravenous nitroglycerin in these patients. We tested this concept after fulfillment of preset systemic hemodynamic resuscitation end points in the early phase of sepsis... CONCLUSIONS:: In the context of a strict resuscitation protocol, based upon fulfillment of systemic hemodynamic end points in patients with early-phase severe sepsis or septic shock, we conclude that intravenous nitroglycerin does not promote sublingual microcirculatory blood flow.

The effect of nitroglycerin as an adjuvant to lidocaine in intravenous regional anesthesia. [2009.06]
PURPOSE: The disadvantages of intravenous regional anesthesia (IVRA) include slow onset, poor muscle relaxation, tourniquet pain, and rapid onset of pain after tourniquet deflation. In this randomized, double-blind study, we evaluated the effect of nitroglycerin (NTG) in quality improvement when added to lidocaine in IVRA... CONCLUSION: The NTG adding to lidocaine in intravenous regional anesthesia shortens onset times of sensory and motor block and decreases the tourniquet and postoperative pain, without any side effect.

Transdermal nitroglycerin as an adjuvant to patient-controlled morphine analgesia after total knee arthroplasty. [2009.03]
BACKGROUND: Nitroglycerin (NTG) has been shown to be a useful adjunct for pain treatment without increasing adverse side effects. The effects of NTG on postoperative morphine consumption after knee replacement were evaluated... CONCLUSIONS: The use of NTG patches conferred no advantage over the use of placebo in patients receiving patient-controlled morphine analgesia after total knee replacement. Two myocardial infarcts occurred in this group. Therefore, the safety of postoperative NTG patch use for pain control must be questioned.

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Clinical Trials Related to Nitroglycerin

MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects [Completed]
The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.

A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon [Active, not recruiting]
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate (GTN) in Men With Angina [Completed]
The purpose of the study is to determine for how long sildenafil potentiates the blood pressure reduction that occurs with glyceryl trinitrate in men with angina.

Nitrate and Hypertension in Heart Transplanted Patients [Completed]
The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood pressure and heart rate in heart-transplanted patients with cyclosporine-induced hypertension.

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter [Recruiting]
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects to determine the effect of topical nitroglycerin on radial artery vasodilation. In the first phase of the study, which is a dose escalation study, each subject will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. The subjects will then return at a later date at which point they will receive the alternate dose on one wrist and placebo on the other. In the second phase of the study, we will randomize the same patients to a mixture of topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be performed as in the first study.

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