IV fluid 5% Dextrose and 0.45% Sodium Chloride Injection large
volume parenteral solution sterile and nonpyrogenic
5% Dextrose and 0.45% Sodium Chloride Injection, USP solution is
sterile and nonpyrogenic. It is a large volume parenteral solution
containing dextrose and sodium chloride in water for injection
intended for intravenous administration.
Content and Characteristics
Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP
contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water
for injection. Electrolytes per 1000 mL: sodium (Na+), 77 mEq;
chloride (Cl−) 77 mEq. The osmolarity is 406 mOsmol/L (calc.),
which is hypertonic. The caloric value is 170 kcal/L.
The pH is 4.3 (3.5 to 6.5).
5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no
bacteriostat, antimicrobial agent or added buffer and is intended
only as a single-dose injection. When smaller doses are required,
the unused portion should be discarded.
5% Dextrose and 0.45% Sodium Chloride Injection, USP is a
parenteral fluid, nutrient and electrolyte replenisher.
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 H20.
The flexible plastic container is fabricated from a clear
multilayer plastic film (FC97). 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.
Content and Characteristics
|Product||Dextrose||Sodium||Sodium||Chloride||Caloric||Tonicity||Osmolarity mOsmol/L (calc)||pH||Container|
| || || || || || |
|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)||250|
|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)||250|
|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|
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
Intravenous solutions containing dextrose and sodium chloride are
indicated for parenteral replenishment of fluid, minimal
carbohydrate calories, and sodium chloride as required by the
clinical condition of the patient.
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
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
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.
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
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.
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.
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.
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.
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
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
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS.
Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic technique, mix
thoroughly and do not store.
INSTRUCTIONS FOR USE
Check for leaks by squeezing container firmly. If leaks are found,
discard unit as sterility may be impaired. If supplemental
medication is desired, follow directions below before preparing for
To Add Medication
(Use aseptic technique)
Remove blue cap from sterile medication additive port at bottom of
With a needle of appropriate length, puncture resealable additive
port and inject. Withdraw needle after injecting medication.
Mix container contents thoroughly.
The additive port may be protected by an appropriate cover.
Preparation for Administration
(Use aseptic technique)
NOTE: See appropriate I.V. administration set Instructions for Use.
Close flow control clamp of administration set.
Remove cap from sterile administration set port at bottom of
Insert piercing pin of administration set into port with a twisting
motion until the pin is firmly seated.
Squeeze and release drip chamber to establish proper fluid level in
Open clamp. Eliminate air from remainder of set.
Attach set to patient access device.
Do not use flexible container in series connections.