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

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

LACSON SYRUP

COMPOSITION:
Each 5 mL of Lacson Syrupcontains lactulose 3,3 g.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
Lactulose is a synthetic disaccharide derivative of lactulose and acts by its osmotic properties in the luminal fluid. The primary osmotic effect of lactulose, which is not absorbed in the upper intestine, may be augmented in the distal ileum and colon by bacterial metabolism of the disaccharide to lactate and other organic acids that are only partially absorbed. There is speculation that the concomitant reduction of luminal pH enhances motility and secretion.
The increased osmotic activity in the lumen that follows administration of lactulose results in modest accumulation of fluid and passage of soft, formed faeces in 1 to 3 days. Another important aspect of the action of lactulose is reduction of intestinal absorption of ammonia, presumably because of reduced production and increased utilization of ammonia by intestinal bacteria and enhanced excretion of ammonia in the faeces.

INDICATIONS:
For the management of constipation and of chronic portal hypertension and hepatic encephalopathy.

CONTRA-INDICATIONS:
Galactosaemia, including patients on a galactose-free diet, and in patients with intestinal obstruction.

DOSAGE AND DIRECTIONS FOR USE:
Constipation:

Adults:	The usual initial dose is 15 to 30 mL (3 to 6 medicine measures) given daily by mouth in a single dose or in 2 divided doses and gradually reduced according to the patient's needs. Maintenance doses of 10 to 15 mL (2 to 3 medicine measures) have been given daily.
Children:	Aged 6 to 12 years may be given initial dose of 20 mL (4 medicine measures) daily. Aged 1 to 5 years may be given initial dose of 10 mL (2 medicine measures) daily. Under 1 year: may be given initial dose of 5 mL (1 medicine measures) daily.

Chronic Portal Hypertension and Hepatic Encephalopathy:
The usual maintenance dose is 30 to 45 mL (6 to 9 medicine measures) three or four times daily; this is adjusted such that there are two or three soft stools daily and a faecal pH of 5 to 5,5. Therapy can be initiated with hourly doses of 30 to 45 mL (6 to 9 medicine measures) if indicated.
Maintenance of the proper pH is essential for appropriate effects on intestinal elimination of ammonia.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Lactulose may cause abdominal discomfort associated with flatulence or cramps. Nausea and vomiting have been reported following high doses. Prolonged use or overdosage may result in diarrhoea with excessive loss of water and electrolytes, particularly potassium.
Care should be taken in patients with lactose intolerance or in diabetic patients because of the presence of some free galactose and lactose.
For management of chronic portal hypertension and encephalopathy other laxatives should not be employed concurrently in order to avoid inadequate acidification of the stool.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions". Treatment is symptomatic.

IDENTIFICATION:
A colourless to brownish-yellow clear or not more than slightly opalescent solution.

PRESENTATION:
Bottles of 150 mL and 500 mL, and containers of 2,5 litres.

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/11.5/55

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited, 7 Fairclough Road, PORT ELIZABETH 6001.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/05/1992
        G400B
        KOHLER C&P P.E

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