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

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

AGAROL LACTULOSE

COMPOSITION:
Each 5 mL AGAROL LACTULOSE contains lactulose 3,3 g.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION.
LACTULOSE produces an osmotic effect in the colon resulting from biodegradation by colonic, bacterial flora into lactic, formic and acetic acid.
LACTULOSE reduces intestinal absorption of ammonia.
Pharmacokinetics:
LACTULOSE passes almost completely unabsorbed from the gastro-intestinal tract and essentially unchanged into the large intestine where it is metabolised by saccharolytic bacteria mainly into lactic acid and small amounts of acetic and formic acids. Urinary excretion of unchanged lactulose has been reported to be 3% or less.

INDICATIONS:

•	Constipation.
•	Hepatic encephalopathy.
•	Chronic portal hypertension.

CONTRA-INDICATIONS:
LACTULOSE is contra-indicated in:

•	Patients with cramps, colic, nausea, vomiting, or any undiagnosed abdominal conditions.
•	Patients on galactose-free diets.
•	Undiagnosed rectal bleeding.
•	Congestive heart failure or hypertension.
•	Diabetes mellitus.
•	Hypersensitivity to the ingredient.

WARNINGS:
LACTULOSE should not be given to children up to 6 years of age unless prescribed by a physician. Since children are not able to describe their symptoms precisely, proper diagnosis should precede the use of a laxative. This will avoid the complication of an existing condition (e.g. appendicitis) or the appearance of more severe side effects.

INTERACTIONS:
Chronic use or overuse of LACTULOSE may reduce serum potassium concentrations by promoting excessive potassium loss from the intestinal tract and may interfere with potassium-retaining effects of potassium-sparing diuretics.

PREGNANCY AND LACTATION.
The safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:

1.	For treatment of constipation
	Dosages can vary depending on the severity of the condition. Initially, a large dose is taken followed by a reduced maintenance dose after the first three days of treatment. Only one daily dose is necessary, preferably in the morning.

Initial dosage
Adults
15 - 30 mL
Children 6 - 12 years
15 - 20 mL
Children 1 - 5 years
10 mL
Infants less than 1 year excluding the neonates
5 mL
Maintenance dosage
Adults
10 - 15 mL
Children 6 - 12 years
10 - 15 mL
Children 1 - 5 years
5 - 10 mL
Infants less than 1 year excluding the neonates
2,5 - 5 mL

2.	Management of hepatic encephalopathy

Initial dosage
30 - 50 mL 3 times daily; this dose is subsequently adjusted to produce 2 to 3 soft stools each day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Less frequently occurring:
Gastro-Intestinal disorders

•	Bloating
•	Cramping
•	Nausea
•	Diarrhoea
•	Gas formation
•	Increased thirst

Special precautions:

•	LACTULOSE should not be given to patients with intestinal obstruction.
•	It should not be used by patients on a low-galactose diet
•	Care should also be taken in patients with a lactose intolerance or in diabetics because of 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 particularly potassium. It may also result in hypernatraemia and exacerbation of hepatic encephalopathy.
Treatment should be symptomatic and supportive.

IDENTIFICATION:
AGAROL Lactulose is a colorless to brownish-yellow, clear or not more than slightly opalescent solution.

PRESENTATION^,
AGAROL Lactulose is packed in the following containers:
Amber PVC bottles of 150 mL and 500 mL and green HDPE plasticans of 2.5 litres.

STORAGE INSTRUCTIONS:
Store below 25ºC in a well-closed container.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
38/11.5/0166

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead

DATE OF PUBLICATION OF THE PACKAGE INSERT:
4 March 2005

574995/050419

68459
UNIPRINT

New addition to this site: February 2010
Source: Pharmaceutical Industry
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