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

Logo GASTROLYTE (POWDER)

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

GASTROLYTE (POWDER)

COMPOSITION:
Each 6,5g contains:
dextrose monohydrate 4,900g, sodium citrate 0,725g, sodium chloride 0,500g and potassium chloride 0,375g.
Each 13g contains: dextrose monohydrate 9,80g, sodium citrate 1,45g, sodium chloride 1,00g and potassium chloride 0,75g.
Each 26g contains: dextrose monohydrate 19,60g, sodium citrate 2,90g, sodium chloride 2,00g and potassium chloride 1,50g.

PHARMACOLOGICAL CLASSIFICATION:
A24 (Mineral substitutes, electrolytes)

PHARMACOLOGICAL ACTION:
The hypotonic solution supplements low electrolyte levels in the body.

INDICATIONS:
Treatment of electrolyte and fluid depletion associated with diarrhoea.

CONTRA-INDICATIONS:
Should not be given to patients with glucose-galactose malabsorption syndrome or with anuria. Care should be taken when given to patients with renal failure and diabetes insipidus.

DOSAGE AND DIRECTIONS FOR USE:
Dissolve the contents of one 6,5g sachet in 250 mL, or the contents of one 13 g sachet in 500 mL, or the contents of one 26 g sachet in 1L of previously boiled and cooled water. The solution should be given hourly in quantities sufficient to provide for the loss of fluid, or as directed by a doctor. In cases of children with acute diarrhoea the solution must be used as indicated by thirst. Any unused solution must be discarded after 24 hours. Do not exceed 26 g (or 1L of solution) per 24 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Glucose intolerance may occur in some patients with diarrhoea. Sodium salts should be administered with caution in patients with cardiac failure, impaired renal failure, hypertension, peripheral and pulmonary 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 sodium may cause hypernatraemia, symptoms of which may include weakness, restlessness, swollen tongue, thirst, reduced salivation and lachrymation, skin flushes, dizziness, headache, pyrexia, oliguria, hypotension, delirium, tachycardia, hyperpnoea and respiratory arrest. Overdosage of potassium chloride may cause hyperkalaemia and paraesthesia of the extremities, mental confusion, listlessness, paralysis, weakness, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Treatment is symptomatic and supportive.

IDENTIFICATION:
White crystalline powder.

PRESENTATION:
Sachets containing either 6.5g, 13g or 26 g.

STORAGE INSTRUCTIONS:
Store in a cool dry place below 25°C. Keep out of reach of children. Store solution in a refrigerator and discard any unused solution after 24 hours.

REGISTRATION NUMBER:
Z/24/154

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ZEDCHEM cc
(Reg. No CK 92/22113/23)
Pama House, Main Road P.O. Box 116
STEENBERG 7945 STEENBERG 7947

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 June 1992

        P600

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