INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HYDROL® Powder

SCHEDULING STATUS
Schedule 0

PROPRIETARY NAME
(and dosage form)

HYDROL® Powder

COMPOSITION
Each 24,69 gram sachet contains:
Sodium chloride 2,0 g
Sodium citrate 2,9 g
Potassium chloride 1,5 g
Dextrose (anhydrous) = Glucose 20 g 18,185 g
Each litre of solution contains the following electrolytes:

  m.mol m.Eq
Sodium 64 64
Chloride 54 54
Potassium 20 20
Citrate 88 29

PHARMACOLOGICAL CLASSIFICATION
A. 24 Mineral substitutes. Electrolytes.

PHARMACOLOGICAL ACTION
HYDROL is a palatable glucose-electrolyte mixture which, when mixed with water as directed, supplements electrolytes and fluids.

INDICATIONS
Treatment of electrolyte and fluid depletion associated with diarrhoea.

CONTRA-INDICATIONS
In patients with impaired renal function. In severe diarrhoea and dehydration requiring parenteral fluid therapy. In patients with the glucose-galactose syndrome.

DOSAGE AND DIRECTIONS FOR USE
Dissolve one sachet in a litre of previously boiled and cooled water. (Do not boil the solution after adding the electrolyte mixture).
Administer the solution in frequent small volumes to compensate for fluid and electrolyte imbalance. Your doctor's advice may be required.
It is recommended to use a feeding bottle for infants and a cup and spoon for small children.
In children with acute diarrhoea this solution must be used as indicated by thirst.
The oral solution should be freshly prepared daily. Discard unused solution after 24 hours.
If patients are unable to drink the oral fluid as recommended due to tiredness or drowsiness, HYDROL can be administered by continuous nasogastric infusion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Glucose malabsorption may occur in a small percentage of patients with acute diarrhoea. Administration of fluids to such cases may worsen the diarrhoea and dehydration.
HYDROL should not be mixed with or given with fruit juices or milk or other electrolyte-containing solutions.
HYDROL should be used as recommended in order to avoid complications with excessive electrolyte ingestion. Excess fluid intake may also cause puffy eyelids. In which case oral therapy should be stopped until this disappears.
Sodium salt should be used with caution in patients with cardiac failure, hypertension, impaired renal function, oedema and in toxaemia of pregnancy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage of glucose may cause nausea and vomiting.
Overdosage of potassium chloride may cause hyperkalaemia, with symptoms such as abnormal sensations in the limbs, listlessness, mental confusion, weakness, paralysis, hypotension and cardiac arrhythmias.
Sodium overdosage may cause hypernatremia with symptoms such as restlessness, weakness, thirst, reduced salivation, swollen tongue, flushing of the skin, fever, dizziness, headache, oliguria, hypotension, tachycardia and gasping breathing.
Treatment is symptomatic.

IDENTIFICATION
White to off-white free flowing powder. When reconstituted, an opaque milk flavoured solution.

PRESENTATION
Cartons containing 10 or more sachets, each filled with 24,69 g powder.

STORAGE INSTRUCTIONS
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
W/24/97

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG logo

JANSSEN PHARMACEUTICA (PTY) LTD.
(Reg. No. 1980/011122/07)
15th Road
HALFWAY HOUSE
1685
© JANSSEN PHARMACEUTICA (PTY) LTD
SOUTH AFRICA

www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
17 February 1989.

® = Trademark
        Code No.: 024402
        2003H
        Britepak

Updated on this site: March 2004
Source: Pharmaceutical Industry

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