Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

NITROGLYCERIN IN DEXTROSE 5% (NDA-019970)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/22/2016 (SUPPL-18)

Approved Drug Label (PDF)

4 Contraindications

Addition of the following:

Nitroglycerin is also contraindicated in patients with increased intracranial pressure.

5 Warnings and Precautions

(addition of the following sentence)

Use of PVC (polyvinyl chloride) tubing in infusion sets may lead to loss of active ingredient due to adsorption of nitroglycerin to PVC tubing, therefore dosage is affected.

Revised sentences below:

Tolerance development and occurrence of cross tolerance to other nitro compounds have been reported.

Administer nitroglycerin in 5% Dextrose Injection via an infusion pump that can maintain a constant infusion rate.

Monitor patients with known sub-clinical or overt diabetes mellitus when using solutions containing dextrose.

6 Adverse Reactions

Addition of:

Dyspnea has also been reported.

7 Drug Interactions

Additions are underlined below:

The vasodilating effects of nitroglycerin may be additive with those of vasodilators antihypertensives (e.g., beta-blockers, calcium channel blockers and tricyclic antidepressants) and may cause increased hypotensive effects.

Concomitant use of Nitroglycerin in 5% Dextrose Injection with phosphodiesterase inhibitors in any form (e.g. sildenafil, tadalafil, or vardenafil) can cause hypotension and is contraindicated.

Concomitant use of Nitroglycerin in 5% Dextrose Injection with riociguat, a soluble guanylate cyclase stimulator, can cause hypotension and is contraindicated.

Nitroglycerin at higher dosages may interfere with the anticoagulant effect of heparin. Intravenous nitroglycerin can induce heparin resistance replaces 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.

Do not mix Nitroglycerin in 5% Dextrose Injection with any other medication of any kind replaces More generally, Nitroglycerin in 5% Dextrose Injection should not be mixed with any other medication of any kind.

8 Use in Specific Populations

Nursing Mothers

Nursing Mothers: It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed child from nitroglycerin or from the underlying maternal condition. (updated)

Pediatric Use

Equations and examples extensively updated; please refer to label.

Studies in the literature used doses of nitroglycerin injection in pediatric patients ranging from 0.5 to 5 mcg/kg/min. The following equation can be used to calculate the flow rate in mL/hour of nitroglycerin using the 100 mcg/mL (25 mg/250 mL) concentration of nitroglycerin.