Ionosol MB and Dextrose

FDA label, ICU Medical Inc., intravenous, effective 2025-10-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

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 Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered. WARNINGS Solutions which contain potassium ions 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.

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. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Preparation and administration

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Basis

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DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. In infants, Ionosol MB and 5% Dextrose Injection is given only after administration of an initial priming solution: 15 mL of half isotonic saline in 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight, administered to small infants at a maximum rate of 0.8 mL/minute.

Infants typically tolerate not more than 150 to 200 mL of Ionosol MB and 5% Dextrose Injection per kg body weight/day. 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.

In adults, intravenous infusions of Ionosol MB and 5% Dextrose Injection are given postoperatively, at a rate not greater than 4 mL/minute. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

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 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

Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered.

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 ionosol mb and dextrose. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Ionosol solutions. It is also not known whether Ionosol solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ionosol solutions 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.

Supply and cost

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