Dextrose in Sodium Chloride solution is indicated in Dehydration accompanied by small Sodium
Chloride deficiency. It provides Dextrose as a nutrient in a suitable medium of Sodium Chloride.
It is usually used in the maintenance and replacement of fluid, electrolyte and carbohydrate in
patients who are unable to take fluid and nutrients by mouth e.g. in pre and post-operative fluid
regime, shock or accidents

Dose is variable. Generally 60-120 drops/minutes are given intravenously or according to
physician’s recommendation. Dose depends on the clinical condition, age and body surface area
of the patients.
Method of administration:
Intravenous infusion route.
Adults, the Elderly, Adolescents and Children:
The dosage and rate of administration of 10% W/V Dextrose in 0.225% W/V Sodium Chloride
Intravenous Infusion B.P is determined by several factors including the age, weight, and clinical
condition of the patient and in particular the patient’s hydration state.

Warnings
10% W/V Dextrose in 0.225% 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 10% W/V Dextrose in 0.225% 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 10% W/V Dextrose in 0.225% 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. 10% W/V Dextrose in
0.225% 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
10% W/V Dextrose in 0.225% W/V Sodium Chloride Intravenous Infusion B.P to patients
receiving corticosteroids or corticotropin.

There are no known drug interactions and none well documented.

Effects on fertility
Studies with 10% W/V Dextrose in 0.225% W/V Sodium Chloride Intravenous Infusion B.P 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 10% W/V Dextrose in 0.225% W/V
Sodium Chloride Intravenous Infusion B.P It is also not known whether 10% W/V Dextrose in
0.225% W/V Sodium Chloride Intravenous Infusion B.P can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. 10% W/V Dextrose in 0.225% W/V
Sodium Chloride Intravenous Infusion B.P 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 10% W/V Dextrose in 0.225% W/V Sodium
Chloride Intravenous Infusion B.P 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 10% W/V Dextrose in 0.225% W/V Sodium Chloride Intravenous Infusion
B.P 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, revaluate the patient's
condition and initiate appropriate corrective treatment.

Pharmacotherapeutic group: Parenteral Preparation for fluid and electrolyte imbalance
10% W/V Dextrose in 0.225% W/V Sodium Chloride Intravenous Infusion B.P 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 deposition

prevents ketosis if sufficient doses are provided.

Excess sodium is mainly excreted by the kidney, and small amounts are lost in the faeces
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 10% W/V Dextrose in 0.225% W/V Sodium
Chloride Intravenous Infusion B.P in pediatric patients have not been established by
adequate and well-controlled 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 10% W/V Dextrose in 0.225% W/V
Sodium Chloride Intravenous Infusion B.P 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.

250ml, 500ml & 1000 ml Plastic bag NPVC.

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