ORS Package Insert

ORAL
REHYDRATION
SALTS
Provides in 200mL solution

Sodium..
mEq
Potassium.
mEq
Chloride.
mEq
Bicarbonate.
Fluitrofill
9.04
4.03
9.50
3.57
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.
dextrose, fructose, invert 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, acidbase balance and electrolyte balance
of the cell. It also works for the
electrodynamic characteristics of the
cell.
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.
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.
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.
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
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.
Warning
Keep out of reach of children.
Dosage
and
Administration
Mode
of
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 individuals bodyweight 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 days 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:

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ORAL

Provides in 200mL solution

Powder for Solution

Electrolyte solutions are used as a

the mild to moderate fluid losses

Directions for Use

Oral rehydration salt (Fluitrofill ) is

Oral rehydration salts (Fluitrofill )

Oral Rehydration Solution should be

compressed as a tablet. And can be

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