Ionosol MB and Dextrose DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5 g/100mL; 260 mg/100mL; 141 mg/100mL; 30 mg/100mL; 15 mg/100mL; 25 mg/100mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Organic acids class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ionosol MB and Dextrose 5 g/100mL; 260 mg/100mL; 141 mg/100mL; 30 mg/100mL; 15 mg/100mL; 25 mg/100mLthis 00990-7372-03 | ICU | 24 pouches | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00990-7372-03 You're viewing this | 24 POUCH in 1 CASE (0990-7372-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2020-01-01 | Active |
| 00990-7372-62 | 24 POUCH in 1 CASE (0990-7372-62) / 1 BAG in 1 POUCH / 250 mL in 1 BAG | 2019-07-01 | Active |
Pack size FAQ
What quantity is in NDC 00990-7372-03?
What NDC number is used to bill for this package of Ionosol MB and Dextrose DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5 g/100mL; 260 mg/100mL; 141 mg/100mL; 30 mg/100mL; 15 mg/100mL; 25 mg/100mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ionosol MB and 5% Dextrose Injection is indicated for intravenous administration to infants for treatment of dehydration, acidosis, diarrhea, and burns, but only after administration of an initial priming solution: 15 mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively for intravenous fluid and electrolyte maintenance therapy, with a small amount of carbohydrate calories for reducing catabolism of endogenous protein reserves.
⏱️ Dosage and Administration ▾
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.
To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. To Administer Attach administration set per manufacturer's instructions.
Regulate rate of administration per institutional policy. WARNING: Do not use flexible container in series connections.
⛔ Contraindications ▾
CONTRAINDICATIONS Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered.
⚠️ Warnings ▾
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.
Solutions containing lactate ions should be used with great care, if at all, in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of lactate ions, such as severe hepatic insufficiency. The intravenous administration of Ionosol MB and 5% Dextrose Injection 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.
🤒 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.
🤰 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.
🧒 Pediatric Use ▾
Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
🧓 Geriatric Use ▾
Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Ionosol MB and 5% Dextrose Injection contains a hypotonic concentration of electrolytes with dextrose. The letters "MB" mean "modified Butler's" solution; the modified solution contains 5 mEq less sodium, 5 mEq more potassium, and 3 mEq added magnesium, as compared with the original Butler's solution. The modified solution can be used in pediatric patients for treatment of dehydration, acidosis, diarrhea, or burns, and in adults for postoperative fluid and electrolyte therapy.
Solutions containing dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.
The lactate anion provides an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, the lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. The lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism.
Since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. When oxidative activity is intact, one to two hours time is required for metabolism of lactate. Magnesium chloride in water dissociates to provide magnesium (Mg ++ ) and chloride (Cl‾) ions.
Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq/liter.
Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration. Phosphate is one of the three major intracellular electrolytes (along with potassium and magnesium) and the largest anion component found within the cells. Its concentration and excretion are largely dependent on intake, acid-base balance and endocrine function.
Its metabolism follows that of calcium in many respects. Phosphate anion in electrolyte solutions may help to repair phosphate deficiency. Potassium chloride in water dissociates to provide potassium (K + ) and chloride (Cl‾) ions.
Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old). Potassium plays an important role in electrolyte balance.
Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.
Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Average normal pediatric daily requirements are based on the child's weight as described in the table below: Weight Fluid Requirements Up to 10 kg 100 mL/kg 11 to 20 kg 1,000 mL + 50 mL/kg for each kg above 10 kg Above 20 kg 1,500 mL + 20 mL/kg for each kg above 20 kg Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments, and sodium (Na + ) plays a major role in…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in flexible plastic single-dose containers as follows: NDC Fill Volume/Container size (mL) ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. 0409-7372-62 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045 USA 250/250 0990-7372-62 250/250 0409-7372-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA 500/500 0990-7372-03 , 500/500 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Revised: August, 2020 ICU Medical, Inc. Lake Forest, Illinois, 60045, USA IFU0000258
📋 Description ▾
DESCRIPTION Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic solution designed for intravenous administration. The solution is formulated to provide fluid and electrolytes for treatment of dehydration and acidosis. Each 100 mL contains dextrose, hydrous 5 g; sodium lactate, anhydrous 260 mg; potassium chloride 141 mg; magnesium chloride, hexahydrate 30 mg; monobasic potassium phosphate, anhydrous 15 mg; and monobasic sodium phosphate, monohydrate 25 mg.
Each liter contains 25 mEq sodium (Na + ); 20 mEq potassium (K + ); 3 mEq magnesium (Mg ++ ); 22 mEq chloride (Cl¯); 3 mM of phosphate (PO 4 ≡); and 23 mEq lactate (CH 3 CH(OH)COO¯). The electrolyte content is hypotonic (100 mOsmol/L) in relation to the extracellular fluid (1pprox.. 280 mOsmol/L).
The osmolarity for the total solution is 352 mOsmol/L (calc.). May contain hydrochloric acid for pH adjustment. pH is 5.0 (4.0 to 6.5). Dextrose, USP, hydrous is chemically designated C 6 H 12 O 6 • H 2 O (D-glucose, monohydrate), a hexose sugar freely soluble in water.
Dextrose, hydrous has the following structural formula: Magnesium Chloride, USP, hexahydrate is chemically designated MgCl 2 • 6H 2 O, colorless flakes or crystals very soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Monobasic Potassium Phosphate, NF, anhydrous is chemically designated KH 2 PO 4 , colorless crystals or white granular powder freely soluble in water.
Sodium Lactate, USP is chemically designated CH 3 CH(OH)COONa, a 60% aqueous solution miscible in water. Monobasic Sodium Phosphate, USP, monohydrate is chemically designated NaH 2 PO 4 • H 2 O, white crystals or granules freely soluble in water. Water for Injection, USP is chemically designated H 2 O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained.
However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. structural formula dextrose