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

Logo SOROL CITRATE (POWDER)

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

SOROL CITRATE (POWDER)

COMPOSITION:
Each 14 g contains: 
Sodium Chloride         1,75g
Potassium Chloride         0,75g
Sodium Citrate         1,45g
Dextrose Monohydrate         10,00g
Flavorant         0,05g
14 g dissolved in 500 mL water gives the following concentration:
Sodium (Na+ )         90 mmol/L
Potassium (K+)         20 mmol/L
Chloride (Cl- )         80 mmol/L
Citrate (C6H5O7)3-         30 mmol/L
Glucose         111 mmol/L

PHARMACOLOGICAL CLASSIFICATION:
A.24 (Mineral substitutes, electrolytes).

PHARMACOLOGICAL ACTION:
The electrolytes in Sorol Citrate powder when dissolved in water to form a hypotonic solution will replenish low levels in the body. The solution is absorbed from the gastro-intestinal tract.

INDICATIONS:
As a hypotonic solution in the treatment of diarrhoea, and gastro-enteritis, replacing the ions sodium, potassium and chloride in the body after excessive fluid and electrolyte loss.

CONTRA-INDICATIONS:
Sorol Citrate should not be administered to patients with glucose-galactose malabsorbtion syndrome. Care should be exercised when given to patients with renal failure and diabetes insipidus. Should not be given to patients with anuria.

DOSAGE AND DIRECTIONS FOR USE:
Dissolve the contents of one 14 g sachet in 500 mL of previously boiled and cooled water. The solution should be given hourly in quantities sufficient to provide for the fluid loss, preferably as directed by a physician. In children with acute diarrhoea this solution must be used as indicated by thirst. Any unused solution must be discarded after 24 hours. Do not exceed 1L solution per 24 hours.

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 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 paraesthesia of the extremities, listlessness, mental confusion, weakness, paralysis, hypotension, cardiac arrhythmia, 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 skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.
Treatment is symptomatic and supportive.

IDENTIFICATION:
White crystalline powder.

PRESENTATION:
Sachets 14 g each.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 30°C
Keep out of reach of Children. Store solution in the refrigerator and discard any unused solution after 24 hours.

REGISTRATION NUMBER:
U/24/141

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
DISMED PHARMACEUTICAL (PTY) LTD (Reg No 98/04386/07)
Unit A3
Tillbury Business Park
Midrand
1685

DATE OF PUBLICATION:
21 August 2000

MARKETED BY RANBAXY (SA) (PTY) LTD

New addition to this site: November 2006
Source: Pharmaceutical Industry

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