10% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion B.P 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  2.5 ml/kg from body weight / hour, i.e. 60 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 10% W/V Dextrose in 0.18% 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.

10% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion B.P should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and clinical states in which there exists oedema with sodium retention. In patients with diminished renal function, 10% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion B.P may result in sodium retention. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

10% W/V Dextrose in 0.18% W/V Sodium Chloride Intravenous Infusion B.P
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 0.18% W/V Sodium Chloride
Intravenous Infusion B.P 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
0.18% W/V Sodium Chloride Intravenous Infusion B.P 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 0.18% 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 10% W/V Dextrose in 0.18% W/V
Sodium Chloride Intravenous Infusion B.P to patients receiving corticosteroids or
corticotropin.

Caution must be exercised in the administration of 10% W/V Dextrose in 0.18% W/V
Sodium Chloride Intravenous Infusion B.P to patients receiving corticosteroids or
corticotropin.

Effects on fertility
Studies with 10% W/V Dextrose in 0.18% 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
0.18% W/V Sodium Chloride Intravenous Infusion B.P It is also not known whether
10% W/V Dextrose in 0.18% 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 0.18% 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
0.18% 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 0.18% 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 0.18% 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
acid-base 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 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 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 0.18% 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 0.18%
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.

4 years. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not store above 30°C.

250ml glass bottles.
250ml & 500ml plastic bottles.

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