ORAL
dextrose, fructose, invert
REHYDRATION
SALTS
Provides in 200mL solution
Sodium……….. 9.04 mEq
Potassium……. 4.03 mEq
Chloride………. 9.50 mEq
Bicarbonate…. 3.57 mEq
Anhydrous
Glucose….7.28g
Fluitrofill
Powder for Solution
Oral Rehydration Salts
Formulation
Each sachet contains:
Sodium chloride…………………… 320mg
Potassium chloride………………..300mg
Sodium bicarbonate……………...300mg
Anhydrous glucose ……………….7.28g
Description of the Product
Oral Rehydration salts (Fluitrofill) are oral
powders for reconstitution containing
Sodium chloride, Potassium chloride,
Sodium bicarbonate and Anhydrous
glucose. After dissolution to the given
required volume of Water, they are
intended to treat and prevent dehydration.
This dehydration is due to diarrhea,
including maintenance therapy. Oral
rehydration salts may contain flavoring
agents. Where necessary, Oral rehydration
salts may contain a satisfactory amount of
flow agents in the minimum quantity
required.
Pharmacology
Electrolyte solutions are used as a source
of electrolyte and water for hydration, or
as alkalinizing agent. It can also contain
carbohydrates which can be a source of
calories (e.g.
sugar, alcohol). For solutions containing
bicarbonate precursors (e.g. acetate,
citrate,lactate). Electrolyte solutions can
also induce dieresis depending on the
clinical condition of the individual. The
main components of the Electrolyte
solution are Sodium, Chloride, and
Potassium . Sodium is the major
component, which is a cation that is
responsible for the extracellular fluid and
functions with the control of water
distribution, fluid and electrolyte balance.
Chloride, the major extracellular anion,
follows the physiologic disposition of
sodium. A change of the serum chloride
concentration is also responsible for the
acid-base balance of the body. Potassium,
a major intracellular cation, is charged for
the maintenance of the isotonicity, acid-
base balance and electrolyte balance of
the cell. It also works for the
electrodynamic characteristics of the cell.
Directions for Use
Oral rehydration salts (Fluitrofill) should
only be reconstituted with water (Fresh
drinking water is appropriate) at the given
volume stated. Solution should not be
boiled after it is prepared and should be
discarded after 24 hours of storage. Other
ingredients such as, sugar, should not be
added.
Indications
Oral Rehydration Salt (Fluitrofill) is used
for fluid or electrolyte depletion. This is for
the maintenance of water and electrolytes,
which is followed by the corrective
parenteral therapy for severe diarrhea.
Also, this replaces the mild to moderate
fluid losses when food and liquid intake is
discontinued. And this is used to restore
the fluids and minerals lost for infants and
children who are having diarrhea and
vomiting. Oral Rehydration salt is also
used for minimizing chronic fatigue,
muscle cramps, or heat prostration
because of excessive perspiration or
sweating, noting that, this is used by
people who are exposed to high
temperature that leads to heat fatigue.
Contraindication
The use of Oral Rehydration salt may lead
to severe, continuing diarrhea or other
critical fluid losses. It can also cause,
intractable vomiting, prolonged shock, and
renal dysfunction (anuria, oliguria). These
require parenteral therapy.
Precaution
Oral rehydration salt (Fluitrofill) is not
suitable for patients diagnosed with
gastrointestinal obstruction, oliguric or
anuric renal failure, or when parenteral
rehydration therapy is indicated in as
severe dehydration or intractable vomiting.
Adverse Reactions
Vomiting may occur when quickly taken
orally. If this occurs, administration should
be halted for 10 minutes then resumed in
smaller doses.
There is a low risk of Hypernatraemia or
overhydration on patients with normal
renal function, only patients who have
renal impairment may have this reaction.
Warning
Keep out of reach of children.
Dosage and Mode of Administration
Oral rehydration salt (Fluitrofill) is used
for oral replacement of fluids and
electrolytes in patients with dehydration,
especially those associated with acute
diarrhea of various aetiologies.
Dosage of the oral rehydration should be
based on the individual’s body-weight and
the severity of the condition. The aim of
the treatment is to rehydrate the patient,
and, subsequently to continue hydration
by replacing fluid losses due to continuing
diarrhea and vomiting, and normal losses
due to sweating, urination and respiration.
Initial rehydration should be rapid of over
3 to 4 hours except if the patient is
hyperpatraemic, in which, in this case,
rehydration should be over 12 hours.
For adults, a normal dose of 200 to 400mL
of oral rehydration solution can be given
for every loose motion.
For children, usual dose of 200mL of oral
rehydration solution can be given every
loose motion. For severe cases, 100mL of
ORS fluid for every kilogram body-weight
is administered every 3 to 4 hours.
For infants, the dose is 1 to 1.5 times their
normal feed volume. Normal feeding can
continue after the fluid deficit has been
corrected. And breast feeding should
continue simultaneously with the
administration of oral rehydration solution.
Symptoms and Treatment of
Overdosage
There is a low risk of Hypernatraemia or
overhydration on patients with normal
renal function, only patients who have
renal impairment may have this reaction.
Patients with renal impairment may lead
to hypernatraemia and hyperkalaemia.
Storage Condition
Oral rehydration salts (Fluitrofill) should
be stored away from moisture. Packaging
should be in sachets, preferably made of
aluminum foil, which is sufficient for a
single dose or a day’s treatment. Oral
Rehydration Solution should be discarded
after 12 to 24 hours of reconstitution.
Availability
Oral Rehydration salts can be as an oral
solution. It can also be compressed as a
tablet. And can be as powder for
reconstitution.
Date of Latest Revision
February 18, 2015
Manufactured by: