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

Logo DARROWPED [SOLUTION]

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DARROWPED [SOLUTION]

COMPOSITION:
Each 15 mL contains:
       
Potassium Chloride        0,225 g
       
Sodium Chloride        0,300 g
       
Sodium Citrate        0,435 g
       
Glucose Monohydrate        3,300 g

PRESERVATIVES:
Nipasept Sodium        0,15% m/v

Each 1000 mL solution contains approximately:
        Potassium        20,1 mmol
        Sodium        63,7 mmol
        Chloride        54,3 mmol
        Citrate        9,9 mmol
        Glucose        111,0 mmol

PHARMACOLOGICAL CLASSIFICATION:
A 24 Mineral substitutes, electrolytes.

PHARMACOLOGICAL ACTION:
The glucose-electrolyte mixture in Darrowped when diluted with water as directed will replenish electrolytes and fluids in the body.

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

CONTRA-INDICATIONS:
Severe diarrhoea where parenteral fluid therapy is required.
Patients with glucose-galactose malabsorption syndrome.
Anuric patients.

WARNINGS:
Contact a doctor, health professional, local clinic or hospital if:

The infant cannot take fluid by mouth, or is becoming weak 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:
Darrowped should be administered with a method that the infant is familiar with e.g. baby bottle, cup or spoon. Breast-feeding mothers may choose any of the aforementioned methods to administer the solution to their infants.

Darrowped should be given in addition to and in between normal feeds/meals in small, frequent and slowly administered amounts.

Darrowped must be freshly prepared by diluting 15 mL in 150 mL of previously boiled and cooled water [one tablespoon in an average cup]. During the first 24 hours it may replace milk.

Infants less than 1 year of age should be given 1/2 to 1 cup [100 - 200 mL] of Darrowped for every time their bowels work.

Children 1 to 5 years of age should be given at last one cup [200 mL] for every time their bowels work.

Older children and adults should drink enough Darrowped 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 Darrowped.

Maintenance of hydration in patients who are unable to take their usual feeds/meals:
Infants less than 1 year of age:        120 mL/kg/day
Children 1 year to 2 years of age:        100 mL/kg/day
Children older than 2 years up to 4 years of age:        85 mL/kg/day
Children older than 4 years up to 10 years:        70 mL/kg/day
Children older than 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:
Glucose intolerance may occur in some patients with diarrhoea.

Sodium salts should be used with caution in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema.

Potassium should be given with caution to patients with renal or adrenal insufficiency, acute dehydration or heat cramp 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 clear orange solution with a salty taste and orange odour.

PRESENTATION:
PVC bottles of 200 mL.

STORAGE INSTRUCTIONS:
Store below 25
°C. Keep bottles tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
E.1106 [Act 101/1965]

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
[Co. Reg. No. 92/04769/07]
Robbie de Lange Road, Wilsonia, EAST LONDON 5200
P O Box 422, EAST LONDON 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
{not stated}

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