IONOSOL MB AND DEXTROSE- dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, mono

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (POTASSIUM CATION - UNII:295O53K152, PHOSPH
Available from:
Hospira, Inc.
INN (International Name):
DEXTROSE MONOHYDRATE
Composition:
DEXTROSE MONOHYDRATE 5 g in 100 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered.
Product summary:
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: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2009 Printed in USA            EN-2269 Hospira, Inc., Lake Forest, IL 60045 USA
Authorization status:
New Drug Application
Authorization number:
0409-7372-03, 0409-7372-62

IONOSOL MB AND DEXTROSE- dextrose monohydrate, sodium lactate, potassium chloride,

magnesium chloride, potassium phosphate, monobasic, and sodium phosphate, monobasic,

monohydrate injection, solution

Hospira, Inc.

----------

Ionos ol

MB and 5% Dextrose Injection

(MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP)

A MAINTENANCE ELECTROLYTE SOLUTION

Flexible Plastic Container

R only

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 ≡); and 23 mEq lactate (CH CH(OH)COO¯).

The electrolyte content is hypotonic (100 mOsmol/L) in relation to the extracellular fluid (approx. 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 H O H 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

6H 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 PO , colorless crystals

®

or white granular powder freely soluble in water.

Sodium Lactate, USP is chemically designated CH CH(OH)COONa, a 60% aqueous solution miscible

in water.

Monobasic Sodium Phosphate, USP, monohydrate is chemically designated NaH PO H O, white

crystals or granules freely soluble in water.

Water for Injection, USP is chemically designated H 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.

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

maintaining physiologic equilibrium.

Ionosol MB and 5% Dextrose Injection contains a hypotonic electrolyte concentration. This should not

be confused with the total tonicity (electrolytes plus nonelectrolytes) of solutions containing both

electrolytes and dextrose. In general, solutions providing isotonic electrolyte concentrations are most

applicable to replacement of acute deficits, whereas hypotonic electrolyte concentrations are best

suited for parenteral maintenance of water requirements when only small quantities of electrolytes are

desired.

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.

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.

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.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid

balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or

whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium

ions, to patients receiving corticosteroids or corticotropin.

Solutions containing lactate ions should be used with caution as excess administration may result in

metabolic alkalosis.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt

diabetes mellitus.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

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.

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.

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.

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.

OVERDOSAGE

In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute

appropriate corrective measures. See WARNINGS and PRECAUTIONS.

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

1. Prepare additive port.

2. 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.

3. The additive port may be protected by covering with an additive cap.

4. Mix container contents thoroughly.

To Administer

1. Attach administration set per manufacturer's instructions.

2. Regulate rate of administration per institutional policy.

WARNING: Do not use flexible container in series connections.

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)

0409-7372-62

250/250

0409-7372-03

500/500

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: October, 2009

Printed in USA EN-2269

Hospira, Inc., Lake Forest, IL 60045 USA

IM-0469

PRINCIPAL DISPLAY PANEL - Overwrap Label

TO OPEN TEAR AT NOTCH

2

HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

IONOSOL MB AND DEXTROSE

dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, monobasic,

and sodium phosphate, monobasic, monohydrate injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 40 9 -7372

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G) (ANHYDROUS DEXTROSE -

UNII:5SL0 G7R0 OK)

DEXTROSE MONOHYDRATE

in 10 0 mL

SO DIUM LACTATE (UNII: TU7HW0 W0 QT) (SODIUM CATION - UNII:LYR4M0 NH37,

LACTIC ACID, UNSPECIFIED FORM - UNII:33X0 4XA5AT)

SODIUM LACTATE

26 0 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION -

UNII:29 5O53K152, CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM CHLORIDE

141 mg

in 10 0 mL

MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O) (MAGNESIUM CATION -

UNII:T6 V3LHY8 38 , CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

MAGNESIUM CHLORIDE

30 mg

in 10 0 mL

PO TASSIUM PHO SPHATE, MO NO BASIC (UNII: 4J9 FJ0 HL51) (POTASSIUM CATION -

UNII:29 5O53K152, PHOSPHATE ION - UNII:NK0 8 V8 K8 HR)

POTASSIUM PHOSPHATE,

MONOBASIC

15 mg

in 10 0 mL

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

(SODIUM CATION - UNII:LYR4M0 NH37, PHOSPHATE ION - UNII:NK0 8 V8 K8 HR)

SODIUM PHOSPHATE,

MONOBASIC,

MONOHYDRATE

25 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 40 9 -7372-6 2

24 in 1 CASE

0 8 /12/20 0 5

1

1 in 1 POUCH

1

250 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 40 9 -7372-0 3

24 in 1 CASE

0 4/30 /20 0 5

2

1 in 1 POUCH

2

50 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Hospira, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 19 513

0 4/30 /20 0 5

Labeler -

Hospira, Inc. (141588017)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira, Inc.

0 9 31328 19

ANALYSIS(0 40 9 -7372) , LABEL(0 40 9 -7372) , MANUFACTURE(0 40 9 -7372) , PACK(0 40 9 -7372)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira, Inc.

8 277310 8 9

ANALYSIS(0 40 9 -7372)

Revised: 11/2019

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