Drugplain

Nitroglycerin In Dextrose 10 mg/100mL

Nitroglycerin · INJECTION · Baxter Healthcare Company

No Recall HistoryCurrently in Shortage
Plain English

Nitroglycerin In Dextrose is a injection containing nitroglycerin at 10 mg/100mL, taken intravenous. Manufactured by Baxter Healthcare Company.

Key Facts

Brand Name
Nitroglycerin In Dextrose
Generic Name
Nitroglycerin
NDC Code (Product)
0338-1047
Manufacturer
Baxter Healthcare Company
Strength
10 mg/100mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019970
Drug Class
Nitrate Vasodilator [EPC]
Marketing Start
12/29/1989

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea3,357 reports
pain3,091 reports
myocardial infarction2,686 reports
fatigue2,679 reports
nausea2,574 reports
fall2,374 reports
chest pain2,334 reports
dizziness2,302 reports
drug ineffective2,276 reports
headache2,097 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.

Dosage & Administration

DOSAGE AND ADMINISTRATION Nitroglycerin in 5% Dextrose Injection is intended for intravenous administration using sterile equipment. Administer Nitroglycerin in 5% Dextrose Injection only via an infusion pump that can maintain a constant infusion rate. Do not use a container which has lost its vacuum, or one in which particulate matter is visible. Dosage is affected by the type of infusion set used (see Warnings ). Although the usual adult starting dose in published studies has been 25 mcg/min or more, these studies used PVC tubing, so the delivered doses were less than those reported. When nonadsorptive tubing is used, doses must be reduced (see Warnings and Precautions ). The dosage must be determined by the patient’s individual requirement and depending on the required response and possible adverse effects (see Adverse Reactions ). Even using nonadsorptive tubing, the dose necessary to achieve a given response will vary greatly from patient to patient. Patients with normal or low left-ventricular filling pressure ( e.g. , patients with uncomplicated angina pectoris) may respond fully to as little as 5 mcg/min, while other patients may require a dose that is one or even two order…

Warnings

WARNINGS 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 (see Dosage and Administration ). Nitroglycerin adsorption 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. Relatively non-adsorptive intravenous administration sets are available. If intravenous nitroglycerin is administered through non-adsorptive tubing, doses based upon published reports will generally be too high. Some in-line intravenous filters also adsorb nitroglycerin; t…

Contraindications

CONTRAINDICATIONS Nitroglycerin in 5% Dextrose 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. Nitroglycerin is also contraindicated in patients with increased intracranial pressure. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Drug Interactions

Drug Interactions: The vasodilating effects of nitroglycerin may be additive with those of 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 (e.g. sildenafil, tadalafil, or vardenafil) can cause hypotension and is contraindicated (see Contraindications ). Concomitant use of Nitroglycerin in 5% Dextrose Injection with riociguat, a soluble guanylate cyclase stimulator, can cause hypotension and is contraindicated (see Contraindications ). Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Nitroglycerin at higher dosages may interfere with the anticoagulant effect of heparin. Intravenous nitroglycerin can induce heparin resistance. Administration of Nitroglycerin in 5% Dextrose Injection through the same infusion set as blood can result in pseudoagglutination and hemolysis. Do not mix Nitroglycerin in 5% Dextrose Injection with any other medication of any kind.

Adverse Reactions

ADVERSE REACTIONS Adverse reactions to nitroglycerin are generally dose-related and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon. Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its …

Frequently Asked Questions

What is Nitroglycerin In Dextrose used for?

Nitroglycerin In Dextrose contains Nitroglycerin. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Nitroglycerin In Dextrose a controlled substance?

Nitroglycerin In Dextrose is not classified as a controlled substance by the DEA.

What is the generic name for Nitroglycerin In Dextrose?

The generic name for Nitroglycerin In Dextrose is Nitroglycerin. There are 11 other brand versions of Nitroglycerin.

What is the NDC code for Nitroglycerin In Dextrose 10 mg/100mL?

The NDC (National Drug Code) for Nitroglycerin In Dextrose 10 mg/100mL is 0338-1047, listed by Baxter Healthcare Company.

Product NDC

0338-1047

Package NDC

0338-1047-02

Other Nitroglycerin In Dextrose Dosages

Other Nitroglycerin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)