4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion has value as a
source of water, electrolytes and calories. It is capable of inducing diuresis depending on
the clinical condition of the patient.

Posology:
As directed by a physician. Dosage is dependent upon the age, weight and clinical condition
of the patient as well as laboratory determinations.

Usually, recommended flow rates  3 ml/kg from body weight / hour, i.e. 70 drops /
minute / 70 kg BW.
Maximum Dosage: 1500 ml/70 kg BW / day.
Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without
producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95%
of the dextrose is retained.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container permit.
Additives may be incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if available. If, in
the informed judgment of the physician, it is deemed advisable to introduce additives, use
aseptic technique. Mix thoroughly when additives have been introduced. Do not store
solutions containing additives.

Method of administration:
Intravenous infusion route.
Adults, the Elderly, Adolescents and Children:
The dosage and rate of administration of 4.3% W/V Dextrose in 0.18% W/V Sodium
Chloride Intravenous Infusion is determined by several factors including the age, weight,
and clinical condition of the patient and in particular the patient’s hydration state.

Warnings
4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion 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.

Injections containing carbohydrates with low electrolyte concentration should not be
administered simultaneously with blood through the same administration set because of the
possibility of pseudoagglutination or hemolysis. The container label for these injections
bears the statement: Do not administer simultaneously with blood.
The intravenous administration of 4.3% W/V Dextrose in 0.18% W/V Sodium Chloride
Intravenous Infusion 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
the injection. The risk of solute overload causing congested states with peripheral and
pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
In patients with diminished renal function, administration of 4.3% W/V Dextrose in
0.18% W/V Sodium Chloride Intravenous Infusion may result in sodium retention.
In very low birth weight infants, excessive or rapid administration of dextrose injection
may result in increased serum osmolality and possible intracerebral hemorrhage.
Potassium salts should never be administered by IV push.

Precautions for use
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.
4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion B.P should be
used with caution in patients with overt or subclinical diabetes mellitus.
Caution must be exercised in the administration of 4.3% W/V Dextrose in 0.18% W/V
Sodium Chloride Intravenous Infusion to patients receiving corticosteroids or
corticotropin.

Caution must be exercised in the administration of 4.3% W/V Dextrose in 0.18% W/V
Sodium Chloride Intravenous Infusion to patients receiving corticosteroids or corticotropin.

Effects on fertility
Studies with 4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion
have not been performed to evaluate carcinogenic potential, mutagenic potential or
effects on fertility.
Use in Pregnancy (Category C)

Animal reproduction studies have not been conducted with 4.3% W/V Dextrose in 0.18%
W/V Sodium Chloride Intravenous Infusion It is also not known whether 4.3% W/V
Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. 4.3% W/V Dextrose
in 0.18% W/V Sodium Chloride Intravenous Infusion should be given to a pregnant woman
only if clearly needed.

Use in Lactation
It is not known whether this drug is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when 4.3% W/V Dextrose in 0.18%
W/V Sodium Chloride Intravenous Infusion is administered to a nursing mother.

Not relevant.

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.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be
consulted.
Symptoms may result from an excess or deficit of one or more of the ions present in the
solution; therefore, frequent monitoring of electrolyte levels is essential.
Hypernatremia may be associated with oedema and exacerbation of congestive heart failure
due to the retention of water, resulting in an expanded extracellular fluid volume.
If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in
an acidifying effect. 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.
If the patient is over 65 years of age or very young he may has an increased chance of
getting side effects.

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

An overdose of 4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion
can result in side effects.

• nausea, vomiting
•  cramps
• diarrhea
•  hyperglycemia
•  decrease in saliva, tears and urination
•  increase in thirst and sweating
•  increase in heart rate
•  dizziness, light headedness, drowsiness, restlessness or irritability
•  swelling of hands ankles and feet
•  headache
•  difficulty breathing or breathlessness which may worsen when lying down
•  Muscle weakness, twitching, rigidity or convulsions.
•  exacerbation of congestive heart failure due to the retention of water                                                     

 Emergency measures

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's
condition and initiate appropriate corrective treatment.

Pharmacotherapeutic group: Parenteral Preparation for fluid and electrolyte imbalance
4.3% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion provides
electrolytes and a source of water for hydration. They are capable of inducing diuresis
depending on the clinical condition of the patient. Sodium, the major action of the
extracellular fluid, functions primarily in the control of water distribution, fluid balance,
and osmotic pressure of body fluids. Sodium is also associated with chloride and

bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major
extracellular anion, closely follows the metabolism of sodium, and changes in the acidbase
balance of the body are reflected by changes in the chloride concentration.
Chloride, the major extracellular anion, closely follows the metabolism of sodium, and
changes in the acid-base balance of the body are reflected by changes in the chloride
concentration.
Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease
losses of body protein and nitrogen, promotes glycogen deposit ion and decreases or
prevents ketosis if sufficient doses are provided.

Excess sodium is mainly excreted by the kidney, and small amounts are lost in the feces
and sweat.
Dextrose rabidly metabolized to carbon dioxide and water.
Special populations:
Hepatic impairment:
Select dosage with extreme caution in liver cirrhosis

Renal insufficiency:
Select dosage with extreme caution in diminished renal function or severe renal
insufficiency; monitor sodium and potassium concentrations.
Pediatric subjects
Safety and effectiveness of Potassium 4.3% W/V Dextrose in 0.18% W/V Sodium Chloride
Intravenous Infusion in pediatric patients have not been established by adequate and wellcontrolled
studies.
Dextrose is safe and effective for the stated indications in pediatric patients.
As reported in the literature, the dosage selection 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.
Frequent monitoring of serum glucose concentrations is required when dextrose is
prescribed to pediatric patients, particularly neonates and low birth weight infants.
In neonates or in very small infants even small volumes of fluid may affect fluid and
electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term
neonates, whose renal function may be immature and whose ability to excrete fluid and

solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be
monitored closely.
Elderly subjects:
Select dosage with caution, usually initiating at the lower end of the usual range, because
of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant
disease or drug therapy.

Not relevant

Water for injections

Many injectable drugs cannot be mixed together with 4.3% W/V Dextrose in 0.18% W/V
Sodium Chloride Intravenous Infusion as some drugs cannot be safely diluted.
Incompatibility can involve in precipitation, ionic reactions, and evolution of gas and
denaturation of biological molecules.
Knowledge of added drug compatibility is needed before mixing drugs.
If drugs mixed together, the mixture should be inspected for precipitations, turbidity or
change in color, however not all incompatibilities are visible.

Do not store above 30°C.

500ml & 1000ml Plastic Bottles.
1000 ml NPVC Bag.

Before administration, the product should be visually inspected for any particulate matter
and discoloration. For single use only. Any unused solution should be discarded.