NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, s

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

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
ICU Medical Inc.
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Normosol-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. None known.
Product summary:
Normosol-R (Multiple Electrolytes Injection Type 1, USP) is supplied in single-dose flexible plastic containers. 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. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2018 EN-4693 ICU Medical, Inc., Lake Forest, IL Illinois, 60045, USA
Authorization status:
New Drug Application
Authorization number:
0990-7967-09

NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium

chloride, and magnesium chloride injection, solution

ICU Medical Inc.

----------

NORMOSOL -R

MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP

For Replacing Acute Losses of Extracellular Fluid

Flexible Plastic Container

R only

DESCRIPTION

Normosol-R is a sterile, nonpyrogenic isotonic solution of balanced electrolytes in water for injection.

The solution is administered by intravenous infusion for parenteral replacement of acute losses of

extracellular fluid.

Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium

gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. May contain

HCl and/or NaOH for pH adjustment. pH 6.6 (4.0 to 8.0); 294 mOsmol/liter (calc.).

Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium

3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq.

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and

is intended only for use as a single-dose injection. When smaller doses are required the unused portion

should be discarded.

Normosol-R is a parenteral fluid and electrolyte replenisher.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in

water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in

water.

Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl

6H O)

deliquescent crystals very soluble in water.

Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C H NaO ), a hygroscopic

powder soluble in water. It has the following structural formula:

Sodium gluconate is chemically designated C H NaO , the normal sodium salt of gluconic acid

soluble in water. It has the following structural formula:

®

Water for Injection, USP is chemically designated H O.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can

permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution

significantly. Solutions in contact with the plastic container may leach out certain chemical components

from the plastic in very small amounts; however, biological testing was supportive of the safety of the

plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will

lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that

these minor losses will lead to clinically significant changes within the expiration period.

CLINICAL PHARMACOLOGY

When administered intravenously, Normosol-R provides water and electrolytes for replacement of

acute extracellular fluid losses without disturbing normal electrolyte relationships. The electrolyte

composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte

concentration is approximately isotonic in relation to the extracellular fluid (approx. 280 mOsmol/liter)

and provides a physiologic sodium to chloride ratio, normal plasma concentrations of potassium and

magnesium and two bicarbonate alternates, acetate and gluconate.

Sodium chloride in water dissociates to provide sodium (Na ) and chloride (Cl¯) ions. Sodium (Na ) is

the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte

disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide

exchange occurs in the red blood cells. The distribution and excretion of sodium (Na ) and chloride

(Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

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.

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.

Sodium acetate provides sodium (Na ) and acetate (CH COO¯) ions, the latter anion (a source of

hydrogen ion acceptors) serving as an alternate source of bicarbonate (HCO ¯) by metabolic

conversion in the liver. This has been shown to proceed readily even in the presence of severe liver

disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during

fluid and electrolyte replacement therapy.

Sodium gluconate provides sodium (Na ) and gluconate (C H O ¯) ions. Although gluconate is a

theoretical alternate metabolic source of bicarbonate (HCO ¯) anion, a significant antiacidotic action

has not been established. Thus, the gluconate anion serves primarily to complete the cation-anion

balance of the solutions.

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.

INDICATIONS AND USAGE

Normosol-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma,

burns or shock. Normosol-R also can be used as an adjunct to restore a decrease in circulatory volume

in patients with moderate blood loss. Normosol-R is not intended to supplant transfusion of whole blood

or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell

volume.

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. 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 during fluid replacement with Normosol-R.

Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic

or respiratory alkalosis. Acetate or gluconate should be administered with great care in those

conditions in which there is an increased level or an impaired utilization of these ions, such as severe

hepatic insufficiency.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in

dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Elderly patients may be at increased risk for the development of fluid overloading and dilutional

hyponatremia following Normosol-R administration.

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

Normosol-R should be used with caution in severe renal impairment because of the danger of

hyperkalemia. As with all intravenous solutions, care should be taken to avoid circulatory overload,

especially in patients with cardiac or pulmonary disorders. Normosol-R is not intended to correct

acidosis or large deficits of individual electrolytes, nor to replace blood or plasma expanders when

these are indicated.

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 acetate or gluconate ions should be used with caution, as excess administration

may result in metabolic alkalosis.

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 Normosol-R. 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.

Pediatric Use.

The safety and effectiveness of Normosol-R have been established in the age groups of birth to 16

years. Use of Normosol-R is supported by evidence from adequate and well-controlled clinical studies

in adults with additional data from post-marketing experience in the pediatric population.

Geriatric Use:

Clinical studies of Normosol-R did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects. Other reported clinical experience

has not identified 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.

Elderly patients have been shown to secrete higher levels of antidiuretic hormone than younger patients,

which may increase the risk of fluid overloading, and dilutional hyponatremia in these patients. See

WARNINGS.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

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. See WARNINGS.

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, re-evaluate the patient and institute appropriate

corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

Normosol-R is administered by intravenous infusion. It may also be administered subcutaneously. The

amount to be infused is based on replacement of losses of extracellular fluid volume in the individual

patient. Up to 3 times the volume of estimated blood loss during and after surgery can be given to

correct circulatory volume when there is only a moderate loss of blood.

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 or discoloration prior to

administration, whenever solution and container permit. See PRECAUTIONS.

Normosol-R does not contain calcium to avoid precipitation of calcium salts that may occur when

certain drugs are added. Solutions which contain calcium in amounts exceeding the normal plasma

concentration may enhance clotting on contact with citrated blood. Hence, Normosol-R can be used for

starting blood transfusion.

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.

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

Normosol-R (Multiple Electrolytes Injection Type 1, USP) is supplied in single-dose flexible plastic

containers.

NDC No.

Product

Container Size (mL)

0409-7967-09

Normosol-R (Multiple Electrolytes Injection Type

1, USP)

1000

0990-7967-09

Normosol-R (Multiple Electrolytes Injection Type

1000

*,†

*,†

0990-7967-09

1, USP)

1000

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.

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

Revised: October, 2018

EN-4693

ICU Medical, Inc., Lake Forest, IL Illinois, 60045, USA

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

1000 mL

NDC 0990-7967-09

NORMOSOL -R

MULTIPLE ELECTROLYTES

INJECTION TYPE 1, USP

EACH 100 mL CONTAINS SODIUM CHLORIDE

526 mg; SODIUM ACETATE, ANHYD. 222 mg;

SODIUM GLUCONATE 502 mg; POTASSIUM

CHLORIDE 37 mg; MAGNESIUM CHLORIDE,

HEXAHYDRATE 30 mg IN WATER FOR

INJECTION. MAY CONTAIN HCI AND/OR NaOH

FOR pH ADJUSTMENT. ELECTROLYTES PER

1000 mL (NOT INCLUDING pH ADJUSTMENT):

SODIUM 140 mEq; POTASSIUM 5 mEq;

MAGNESIUM 3 mEq; CHLORIDE 98 mEq;

ACETATE 27 mEq; GLUCONATE 23 mEq.

294 mOsmol/LITER (CALC). pH 6.6 (4.0 TO 8.0)

ADDITIVES MAY BE INCOMPATIBLE.

CONSULT WITH PHARMACIST, IF

AVAILABLE. WHEN INTRODUCING

ADDITIVES, USE ASEPTIC TECHNIQUE,

MIX THOROUGHLY AND DO NOT STORE.

SINGLE-DOSE CONTAINER. FOR (IV) OR

SUBCUTANEOUS USE. USUAL DOSAGE: SEE

INSERT. STERILE, NONPYROGENIC. USE ONLY

IF SOLUTION IS CLEAR AND CONTAINER IS

UNDAMAGED. MUST NOT BE USED IN SERIES

CONNECTIONS.

Rx ONLY

CONTAINS DEHP

IM-4414

Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 6004 5, USA

Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 6004 5, USA

*,†

ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

icumedical

NORMOSOL-R

sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride

injection, solution

ICU Medical Inc.

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 9 9 0 -79 6 7

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

526 mg

in 10 0 mL

SO DIUM ACETATE ANHYDRO US (UNII: NVG71ZZ7P0 ) (SODIUM CATION -

UNII:LYR4M0 NH37)

SODIUM ACETATE

ANHYDROUS

222 mg

in 10 0 mL

SO DIUM GLUCO NATE (UNII: R6 Q379 1S76 ) (SODIUM CATION - UNII:LYR4M0 NH37)

SODIUM GLUCONATE

50 2 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

37 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

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 9 0 -79 6 7-0 9

12 in 1 CASE

0 9 /18 /20 19

1

1 in 1 POUCH

1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 1758 6

0 9 /18 /20 19

Labeler -

ICU Medical Inc. (118380146)

Revised: 6/2020

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