Drugplain

Dextrose and Sodium Chloride 5 g/100mL

DEXTROSE MONOHYDRATE and SODIUM CHLORIDE · INJECTION, SOLUTION · ICU Medical Inc.

No Recall HistoryCurrently in Shortage
Plain English

Dextrose and Sodium Chloride is a injection, solution containing dextrose monohydrate and sodium chloride at 5 g/100mL, taken intravenous. Manufactured by ICU Medical Inc..

Key Facts

Brand Name
Dextrose and Sodium Chloride
Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
NDC Code (Product)
0990-7924
Manufacturer
ICU Medical Inc.
Strength
5 g/100mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA017606
Marketing Start
09/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

vomiting41 reports
nausea35 reports
death32 reports
hyponatraemia28 reports
abdominal distension27 reports
ascites27 reports
constipation27 reports
sepsis27 reports
abdominal pain26 reports
general physical health deterioration25 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

Dosage & Administration

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. INSTRUCTIONS FOR USE: Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open 1. Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is no…

Warnings

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Contraindications

CONTRAINDICATIONS None known.

Drug Interactions

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Adverse Reactions

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Dextrose and Sodium Chloride used for?

Dextrose and Sodium Chloride contains DEXTROSE MONOHYDRATE and SODIUM CHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Dextrose and Sodium Chloride a controlled substance?

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

What is the generic name for Dextrose and Sodium Chloride?

The generic name for Dextrose and Sodium Chloride is DEXTROSE MONOHYDRATE and SODIUM CHLORIDE. There are no other listed brand versions of DEXTROSE MONOHYDRATE and SODIUM CHLORIDE.

What is the NDC code for Dextrose and Sodium Chloride 5 g/100mL?

The NDC (National Drug Code) for Dextrose and Sodium Chloride 5 g/100mL is 0990-7924, listed by ICU Medical Inc..

Product NDC

0990-7924

Package NDC

0990-7924-02

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

Data from openFDA · Public domain (CC0 1.0)