Dextrose, sodium chloride, potassium acetate, and magnesium acetate

FDA label, ICU Medical Inc., intravenous, effective 2025-10-24. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

CONTRAINDICATIONS None known. 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. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

Preparation and administration

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Basis

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DOSAGE AND ADMINISTRATION Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M 2 of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth.

The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters. 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.

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.

See PRECAUTIONS . INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration.

Contraindications

None known.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for dextrose, sodium chloride, potassium acetate, and magnesium acetate. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-M and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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