PHARMACOLOGICAL ACTION: Laevolac® 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 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. Another aspect of action of lactulose is reduction of intestinal 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. Patients with intestinal obstruction.
DOSAGE AND DIRECTIONS FOR USE: (A) CONSTIPATION:
Dosages vary widely with the severity of the condition. A relatively large initial dose should be followed by a smaller maintenance dose. Doses are given daily by mouth in a single dose or in 2 divided doses. The full effect may not be attained for a few days.
Recommended dosages are as follows:
USUAL STARTING DOSE:
30 mL (6 x 5 mL medicine measure)
CHILDREN (6 - 14 years):
15 mL (3 x 5 mL medicine measure)CHILDREN (1 - 5 years):
10 mL (2 x 5 mL medicine measure)INFANTS:
5 mL (1 x 5 mL medicine measure)MAINTENANCE DOSE:
15 - 30 mL (3 - 6 x 5 mL medicine measure)CHILDREN (6 - 14 years):
10 - 15 mL (2 - 3 x 5 mL medicine measure)CHILDREN (1 - 5 years):
5 - 10 mL (1 - 2 x 5 mL medicine measure)INFANTS:
2,5 - 5 mL (½ - 1 x 5 mL medicine measure)(B) PORTAL SYSTEMIC ENCEPHALOPATHY:
Initial dose of 30 - 50 mL, 3 times daily. Subsequently adjust the dose to produce 2 to 3 soft stools daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Laevolac® may cause abdominal discomfort associated with flatulence or cramps on initiation of therapy. 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.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side-effects and special precautions. Treatment is symptomatic and supportive.
IDENTIFICATION: A clear, colourless to brownish-yellow syrup.
PRESENTATION: 100 mL and 500 mL bottles.
STORAGE INSTRUCTIONS: Store at temperatures not exceeding 25°C. Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER: Z/11.5/101
NAME AND BUSINESS ADDRESS OF THE APPLICANT: MADAUS PHARMACEUTICALS (PTY) LTD.
Cnr 16th Road and 2nd Street,
Halfway House 1685.
DATE OF PUBLICATION OF THIS PACKAGE INSERT: June 1992
® Is the registered trademark of Laevosan Ges.m.b.H., Austria.
Postal Address: MADAUS PHARMACEUTICALS (PTY) LTD.
P.O. Box 3435
Halfway House 1685