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

Logo REHIDRAT® ORANGE Powder
        050/CS1

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

REHIDRAT® ORANGE Powder

COMPOSITION:
Each 14 g sachet contains:
Sodium chloride         0,44 g
Potassium chloride         0,38 g
Sodium bicarbonate         0,42 g
Glucose         4,16 g
Sucrose         8,07 g

The reconstituted REHIDRAT ORANGE and water solution
had the following composition:		         mmol/L
Sodium         50
Potassium         20
Chloride         50
Bicarbonate         20
Citrate         9
Glucose         91
Sucrose         94
Fructose         2
Total osmolality         336

PHARMACOLOGICAL CLASSIFICATION:
A 24 Mineral substitutes, electrolytes.

PHARMACOLOGICAL ACTION:
REHIDRAT ORANGE powder is a glucose-electrolyte mixture which, when mixed with water as directed replenishes electrolytes and fluids.

INDICATIONS:
Prevention and treatment of dehydration and electrolyte depletion associated with diarrhoea and gastro-enteritis.

CONTRA-INDICATIONS:
Rehidrat is contra-indicated in patients with renal impairment manifesting as oliguria or anuria, intestinal obstruction, paralytic ileus and intractable vomiting.
Severe diarrhoea where parenteral fluid therapy is required. Patients with glucose - galactose malabsorption syndrome.

WARNINGS:
Contact a doctor, health professional, local clinic or hospital if:
• The infant cannot take fluid by mouth, or is becoming weaker and dehydrated.
• Severe diarrhoea continues for 12 hours.
Care should be exercised when the formulation is given to patients with renal failure and diabetes insipidus.

DOSAGE AND DIRECTIONS FOR USE:
Oral rehydration solution should be administered with a method that the infant is familiar with eg. baby bottle, cup or spoon. Breastfeeding mothers may choose any of the aforementioned methods to administer the solution to their infants.
Rehidrat should be given in addition to and in between normal feeds/meals in small, frequent and slowly administered amounts.
The contents of one 14 g sachet should be dissolved in 250 mL of freshly boiled and cooled water.
The solution must be freshly prepared every day. Discard unused solution after 24 hours.
Infants and Children:
During the rehydration phase of therapy, care should be taken to ensure an adequate intake of Rehidrat to replace the deficits of water and electrolytes (see recommended daily dose in Maintenance Therapy section below).
Maintenance Therapy:
Patients should be observed carefully to confirm adequate maintenance of hydration.
Frequent clinical observations should be made to ensure that adequate hydration is being maintained. The maximal dosage of Rehidrat should not be exceeded. If further fluid intake is required, free water should be given.
Infants less than 1 year of age should be given ½ to 1 cup (100 - 200 mL) of Rehidrat for every time their bowels work.
Children 1 to 5 years of age should be given at least one cup (200 mL) for every time their bowels work.
Older children and adults should drink enough Rehidrat to quench their thirst and replace the fluid lost in every stool.
If fluid volumes and body mass can be measured the following doses can be used instead of those above and a nasogastric tube can be used to administer Rehidrat:
Maintenance of hydration in patients unable to take usual feeds/meals:
Infants less than 1 year of age: 120 mL/kg/day
Children 1-2 years of age: 100 mL/kg/day
Children 2-4 years of age: 85 mL/kg/day
Children 4-10 years of age: 70 mL/kg/day
Children over 10 years of age and adults: 2 to 3 litres/day
Rehydration in mild dehydration:
50 mL/kg body mass over the first 6 hours, followed by maintenance therapy.
Rehydration in moderate to severe dehydration:
100 mL/kg body mass over the first 6 hours, followed by maintenance therapy.
Patients with moderate to severe dehydration are preferably rehydrated via the intravenous route with specially formulated intravenous dextrose-electrolyte solutions.
Ongoing losses:
For every stool passed 10 to 20 mL/kg body mass should be given in addition to and in between normal feeds/meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Rehidrat should not be mixed or given with other oral electrolyte solutions. Salt or sugar should not be added to Rehidrat. When Rehidrat is used alone or as a supplement to parenteral fluid therapy, care must be taken not to exceed the total water and electrolyte requirements.
The sugar content of Rehidrat should be considered when treating diabetic patients. Administration of oral sugar-electrolyte solutions to patients with sugar malabsorption may worsen the diarrhoea. Glucose intolerance may occur in some patients with diarrhoea.
Sodium salts should be used with caution in patients with cardiac failure, hypertension, peripheral and pulmonary oedema. Potassium should be given with caution to patients with renal or adrenal insufficiency, acute dehydration or heat cramps as well as patients receiving potassium-sparing diuretics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of glucose may cause nausea and vomiting.
Overdosage of potassium may cause hyperkalaemia with paraesthesia of the extremities, listlessness, mental confusion, weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest.
Overdosage of sodium may cause hypernatraemia, symptoms of which may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A white powder.

PRESENTATION:
Foil/laminate sachet containing 14 g of granular powder.

STORAGE INSTRUCTIONS:
Store in a dry place below 30°C.
Keep out of reach of children.

REGISTRATION NUMBER:
Y/24/181

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Searle, Division of Monsanto South Africa (Pty) Ltd
7 Harrowdene Office Park
Western Services Road
Woodmead X20
Sandton

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 1991

5438200-4-5/00
                KNLE1

Current: February 2004
Source: Community Pharmacy

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