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

Logo LAXETTE SOLUTION

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

LAXETTE SOLUTION

COMPOSITION:
Each 5 mL LAXETTE contains 3,3 g
lactulose.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
LAXETTE is a synthetic disaccharide of fructose and galactose, which is not split into its monosaccharide constituents in the small intestine due to the lack of a specific enzyme. It reaches the colon unchanged where it is broken down by the saccharolytic flora into organic acids, such as lactic acid and acetic acid - acids formed in the colon under physiological conditions. Due to this local osmotic effect in the colon, water is retained, the faecal mass softened and normal colonic peristalsis restored.
In portal systemic encephalopathy administration of large doses of LAXETTE results in a significant reduction in the pH of the colonic contents. Lowering the pH promotes conversion of non-ionised ammonia into ionised form. The latter form being non-absorbable leads to reduction of absorption of ammonia from the intestine into the portal circulation and may even promote the excretion of ammonia from the circulation into the faeces.
LAXETTE cannot be hydrolysed in the intestine, thus very little absorption occurs. Small amounts of non-hydrolysed lactulose may be absorbed, but these are readily excreted via the kidneys.

INDICATIONS:
Management of constipation.
Portal systemic encephalopathy, hepatic coma or precoma stages where hyper-ammonaemia is present.

CONTRA-INDICATIONS:
Patients on a low galactose diet or lactulose intolerance.
Patients with gastrointestinal obstruction.

DOSAGE AND DIRECTIONS FOR USE:
Constipation:
Dosage can vary widely with the severity of the condition. A relatively large initial dose should be followed by a smaller maintenance dose after the first three days of treatment. Only one dose daily needs to be taken preferably after breakfast.
Recommended dosages are as follows:
USUAL STARTING DOSE:
Adults:         30 mL
Children 6 - 14 years:         15 mL
Children 1 - 5 years:         10 mL
Infants:         5 mL
MAINTENANCE DOSE:
Adults:         15 - 30 mL
Children 6 - 14 years:         10 - 15 mL
Children 1 - 5 years:         5 - 10 mL
Infants: 2,5 - 5 mL
PORTAL SYSTEMIC ENCEPHALOPATHY:
Initial dose of 30 - 50 mL, three times daily. Subsequently adjust the dose to produce two or three soft stools daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
It may cause abdominal discomfort associated with flatulence or cramps. Nausea and vomiting have occasionally been reported on the high initial doses. Care should be taken in patients with lactose intolerance or in diabetic patients due to the presence of some free galactose and lactose.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Prolonged use or excessive dosage may result in diarrhoea, with excessive loss of water and electrolytes. Treatment is symptomatic and supportive.

IDENTIFICATION:
A colourless to brownish-yellow solution with a sweet taste.

PRESENTATION:
150 mL and 500 mL amber glass bottles or 2,5L amber or white plastic containers.

STORAGE INSTRUCTIONS:
Store below 20°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/11.5/0609

NAME AND BUSINESS ADDRESS OF APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Rosen Heights, Pasita Street, ROSENPARK 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1995

                        100278 - 6/99        Unified

Updated on this site: February 2001

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