Drugplain

Dextrose 25 g/50mL

Dextrose Monohydrate · INJECTION, SOLUTION · Henry Schein, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Dextrose injection is a sugar solution given through a vein to treat low blood sugar or to provide calories and fluid to patients who cannot eat by mouth. It works quickly to raise blood sugar levels and is commonly used in hospitals and emergency settings.

Key Facts

Brand Name
Dextrose
Generic Name
Dextrose Monohydrate
NDC Code (Product)
0404-9847
Manufacturer
Henry Schein, Inc.
Strength
25 g/50mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019445
Marketing Start
01/10/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective13,065 reports
off label use11,060 reports
nausea9,935 reports
dyspnoea9,790 reports
pain8,769 reports
diarrhoea8,762 reports
fatigue8,720 reports
pyrexia7,950 reports
acute kidney injury7,860 reports
vomiting7,534 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. [See Dosage and Administration (2) .] ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is an anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See the device operator's manual for additional information and complete usage instructions. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to blood products collected for extracorporeal processing. ( 2 ) ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A may only be used with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. For instructions on the use of the solution see the device operator's manual. ( 2.1 ) Follow the directions for drawing ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A into a syringe for further processing of the collected blood product. ( 2.2 ) 2.1 General Dosing Information ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A is added to blood products collected for extracorporeal processing. The solution is manually added to collected blood products to facilitate extracorporeal processing. The amount of solution added is specified by the manufacturer of the processing set. It is not intended for direct intravenous infusion. For instructions on the use of the solution with the processing set, see the device operator's manual. 2.2 Administration Ensure solution is the ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD) SOLUTION A and is with…

Contraindications

4 CONTRAINDICATIONS NOT FOR PREPARATION OF BLOOD PRODUCTS FOR TRANSFUSION OR FOR DIRECT INTRAVENOUS INFUSION. NOT FOR PREPARATION OF BLOOD PRODUCTS FOR TRANSFUSION OR FOR DIRECT INTRAVENOUS INFUSION. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Citrate reactions or toxicity may occur with the injection of blood products containing citrate anticoagulant. The recipient of the blood product containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Dextrose used for?

Dextrose injection is a sugar solution given through a vein to treat low blood sugar or to provide calories and fluid to patients who cannot eat by mouth. It works quickly to raise blood sugar levels and is commonly used in hospitals and emergency settings.

Is Dextrose a controlled substance?

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

What is the generic name for Dextrose?

The generic name for Dextrose is Dextrose Monohydrate. There are 8 other brand versions of Dextrose Monohydrate.

What is the NDC code for Dextrose 25 g/50mL?

The NDC (National Drug Code) for Dextrose 25 g/50mL is 0404-9847, listed by Henry Schein, Inc..

Product NDC

0404-9847

Package NDC

0404-9847-50

Other Dextrose 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)