DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate and sodium chloride injection, solution
Dextrose and Sodium Chloride by
Drug Labeling and Warnings
Dextrose and Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by ICU Medical Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Dextrose and Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing various concentrations and combinations of these drugs in water for injection intended for intravenous administration.
See Table for summary of content and characteristics of these solutions.
The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.
The solutions are parenteral fluid, nutrient and electrolyte replenishers.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
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 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.
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CLINICAL PHARMACOLOGY
When administered intravenously, these solutions provide a source of water, carbohydrate and electrolytes.
Solutions which provide combinations of hypotonic or isotonic concentrations of dextrose and of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements with minimal carbohydrate calories.
Solutions containing carbohydrate in the form of 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.
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.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). 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
- CONTRAINDICATIONS
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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.
Excessive administration of potassium-free solutions may result in significant hypokalemia.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of these solutions 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.
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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.
Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.
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 dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.
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. 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. Sodium ions are 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.
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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.
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OVERDOSAGE
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
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DOSAGE AND ADMINISTRATION
The dose is dependent upon the age, weight and clinical condition of the patient.
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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
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INSTRUCTIONS FOR USE
To Open:
Tear outer wrap at notch and remove solution container. 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.
Preparation for Administration
(Use aseptic technique)- Close flow control clamp of administration set.
- Remove cover from outlet port at bottom of container.
- Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange.
- Suspend container from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber.
- Attach venipuncture device to set.
- Open clamp to expel air from set and venipuncture device. Close clamp.
- Perform venipuncture.
- Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
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HOW SUPPLIED
Dextrose and Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table.
Content and Characteristics - * Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
- † Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
Grams/100 mL
Per 1000 mL
NDC No.
Product
Dextrose
(hydrous)
Sodium
Chloride
Sodium
Na+
Chloride
Cl¯
Caloric
Value
Tonicity
Osmolarity mOsmol/L (calc)
pH
Container
size (mL)
5% Dextrose and 0.225% Sodium Chloride Inj., USP
5
0.225
38.5 mEq
38.5 mEq
170
Hypertonic
329
4.3 (3.5 to 6.5)
250
5% Dextrose and 0.225% Sodium Chloride Inj., USP
5
0.225
38.5 mEq
38.5 mEq
170
Hypertonic
329
4.3 (3.5 to 6.5)
500
5% Dextrose and 0.225% Sodium Chloride Inj., USP
5
0.225
38.5 mEq
38.5 mEq
170
Hypertonic
329
4.3 (3.5 to 6.5)
1000
5% Dextrose and 0.3% Sodium Chloride Inj., USP
5
0.3
51 mEq
51 mEq
170
Hypertonic
355
4.3 (3.5 to 6.5)
500
5% Dextrose and 0.3% Sodium Chloride Inj., USP
5
0.3
51 mEq
51 mEq
170
Hypertonic
355
4.3 (3.5 to 6.5)
1000
5% Dextrose and 0.45% Sodium Chloride Inj., USP
5
0.45
77 mEq
77 mEq
170
Hypertonic
406
4.3 (3.5 to 6.5)
250
5% Dextrose and 0.45% Sodium Chloride Inj., USP
5
0.45
77 mEq
77 mEq
170
Hypertonic
406
4.3 (3.5 to 6.5)
500
5% Dextrose and 0.45% Sodium Chloride Inj., USP
5
0.45
77 mEq
77 mEq
170
Hypertonic
406
4.3 (3.5 to 6.5)
1000
5% Dextrose and 0.9% Sodium Chloride Inj., USP
5
0.9
154 mEq
154 mEq
170
Hypertonic
560
4.3 (3.5 to 6.5)
500
5% Dextrose and 0.9% Sodium Chloride Inj., USP
5
0.9
154 mEq
154 mEq
170
Hypertonic
560
4.3 (3.5 to 6.5)
1000
ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.
Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Revised: August, 2018
EN-4684
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PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC: 0990-7924-09
1000 mL
NDC: 0990-7924-095% DEXTROSE
and 0.225%
SODIUM CHLORIDE
Injection, USPEACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g; SODIUM CHLORIDE
225 mg IN WATER FOR INJECTION.
ELECTROLYTES PER 1000 mL: SODIUM
38.5 mEq; CHLORIDE 38.5 mEq.
329 mOsmol/LITER (CALC).
pH 4.3 (3.5 to 6.5).
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 I.V.
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
3
V
CONTAINS DEHPIM-4424
icumedical
ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
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PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap - NDC: 0990-7924-09
2
HDPETO OPEN TEAR AT NOTCH
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
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PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC: 0990-7925-09
1000 mL
NDC: 0990-7925-095% DEXTROSE
and 0.3%
SODIUM CHLORIDE
Injection, USPEACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g; SODIUM CHLORIDE
300 mg IN WATER FOR INJECTION.
ELECTROLYTES PER 1000 mL:
SODIUM 51 mEq; CHLORIDE 51 mEq.
355 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5)
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 I.V.
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
3
V
CONTAINS DEHPIM-5164
icumedical
Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
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PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC: 0990-7926-09
1000 mL
NDC: 0990-7926-095% DEXTROSE
and 0.45%
SODIUM CHLORIDE
Injection, USPEACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g; SODIUM CHLORIDE
450 mg IN WATER FOR INJECTION.
ELECTROLYTES PER 1000 mL: SODIUM
77 mEq; CHLORIDE 77 mEq.
406 mOsmol/LITER (CALC).
pH 4.3 (3.5 to 6.5).
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 I.V.
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
3
V
CONTAINS DEHPicumedical
IM-4425
ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
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PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC: 0990-7941-09
1000 mL
NDC: 0990-7941-095% DEXTROSE
and 0.9%
SODIUM CHLORIDE
Injection, USPEACH 100 mL CONTAINS DEXTROSE,
HYDROUS 5 g; SODIUM CHLORIDE
900 mg IN WATER FOR INJECTION.
ELECTROLYTES PER 1000 mL: SODIUM
154 mEq; CHLORIDE 154 mEq.
560 mOsmol/LITER (CALC).
pH 4.3 (3.5 to 6.5)
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 I.V.
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
3
V
CONTAINS DEHPicumedical
IM-4427
ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
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INGREDIENTS AND APPEARANCE
DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate and sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-7924 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 5 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.225 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-7924-02 24 in 1 CASE 09/01/2019 1 1 in 1 POUCH 1 250 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC: 0990-7924-03 24 in 1 CASE 12/01/2019 2 1 in 1 POUCH 2 500 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC: 0990-7924-09 12 in 1 CASE 12/01/2019 3 1 in 1 POUCH 3 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017606 09/01/2019 DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate and sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-7925 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 5 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-7925-03 24 in 1 CASE 11/25/2019 1 1 in 1 POUCH 1 500 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC: 0990-7925-09 12 in 1 CASE 12/01/2019 2 1 in 1 POUCH 2 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017799 09/01/2019 DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate and sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-7926 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 5 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.45 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-7926-02 24 in 1 CASE 09/01/2019 1 1 in 1 POUCH 1 250 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC: 0990-7926-03 24 in 1 CASE 12/01/2019 2 1 in 1 POUCH 2 500 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC: 0990-7926-09 12 in 1 CASE 12/01/2019 3 1 in 1 POUCH 3 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017607 09/01/2019 DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate and sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 0990-7941 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 5 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.9 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0990-7941-03 24 in 1 CASE 12/01/2019 1 1 in 1 POUCH 1 500 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC: 0990-7941-09 12 in 1 CASE 11/15/2019 2 1 in 1 POUCH 2 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017585 09/01/2019 Labeler - ICU Medical Inc. (118380146)
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