Dextrose 20 g/100mL
dextrose · INJECTION, SOLUTION · ICU Medical Inc.
Dextrose is a injection, solution containing dextrose at 20 g/100mL, taken intravenous. Manufactured by ICU Medical Inc..
Key Facts
- Brand Name
- Dextrose
- Generic Name
- dextrose
- NDC Code (Product)
0990-7935- Manufacturer
- ICU Medical Inc.
- Strength
- 20 g/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018564
- Marketing Start
- 10/01/2019
Recall History
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmedium Services, LLC
Subpotent Drug
Pfizer Inc.
Lack of Assurance of Sterility: Bags have the potential to leak.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Med Prep Consulting, Inc.
Non-Sterility; mold contamination
Fresenius Medical Care, North America
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 contains dextrose. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
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. There are 10 other brand versions of dextrose.
What is the NDC code for Dextrose 20 g/100mL?
The NDC (National Drug Code) for Dextrose 20 g/100mL is 0990-7935, listed by ICU Medical Inc..
Other Dextrose Dosages
Other Dextrose Brands
See all →- Potassium Chloride in Dextrose and Sodium Chloride50 g/1000mL0990-7903
- Dextrose and Sodium Chloride5 g/100mL0990-7924
- Dextrose and Sodium Chloride5 g/100mL0990-7926
- Good Neighbor Anti Nausea Cherry Flavor1.87 g/5mL46122-729
- Dextrose monohydrate25 g/50mL51662-1584
- Dextrose And Sodium Chloride10 g/100mL0264-7623
- Potassium Chloride in Dextrose and Sodium Chloride5 g/100mL0264-7636
- DEXTROSE5 g/100mL0338-0070
- DEXTROSE5 g/100mL0338-0082
- Potassium Chloride in Dextrose and Sodium Chloride50 g/1000mL65219-146
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)