Lactulose Solution Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Solution BP
|
Lactulose |
3.3 g |
|
Galactose |
0.4 g |
|
Lactose |
04g |
|
Tagatose |
0.05 g |
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
In constipation and hepatic encephalopathy.
4.2 Posology and method of administration
Oral administration
Dose: expressed in twice of the syrup containing 3.3g/5ml In Constipation:
Adults: Initially 15m1 twice daily, gradually reducing according to patients needs.
Children:
|
Under 1 year: |
2.5ml |
|
1 to 5 years: |
5.0ml |
|
5 to 12 years: |
10.0ml twice daily gradually reduced. |
No special recommendations in the elderly.
In Hepatic Encephalopathy:
30 to 50ml 3 times daily, subsequently adjusted to produce 2 to 3 soft stools daily.
No special recommendations. Doses should be taken with liquids or food.
4.3 Contraindications
Contains galactose: Patients with rare hereditary problems of galactose intolerance e.g. galacotosaemia, or glucose-galactose malabsorption should not take this medicine.
Intestinal obstruction.
Contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
It must be used cautiously in diabetics.
The product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. (See Section 4.3)
4.5 Interaction with other medicinal products and other forms of interaction
No known interactions.
4.6 Fertility, Pregnancy and lactation
There is no evidence to suggest that Lactulose cannot be used in pregnancy or in lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Flatulence, cramps, abdominal discomfort have occurred seldomly especially when therapy is initiated. (These symptoms occur in about 20% of patients receiving full doses of the drug). Nausea and vomiting have also been reported particularly with higher dosage.
4.9 Overdose
Excessive dosage can cause diarrhoea, loss of fluid and potassium and exacerbation of hepatic encephalopathy. Lost fluid and electrolytes must be replaced and dosage reduced.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Lactulose is an osmotic laxative. Its laxative action is due to a non-specific response to the acidity of the bowel contents which occur when Lactulose is metabolised by saccharolytic enzymes of the colon flora into organic acid such as lactic acids.
5.2 Pharmacokinetic properties
Lactulose is not absorbed or metabolised in the small intestine and is only partially absorbed upon reaching the colon. It is metabolised in the colon by the action of the colon flora i.e. saccharolytic enzymes of the flora degrade Lactulose into organic acids such as lactic acid.
The amount of unmodified Lactulose in the urine is very slight and even more remote in the faeces or bile.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Purified Water
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Keep tightly closed. Store in a cool dry place below 20°C.
6.5 Nature and contents of container
White plastic/PVC containers and caps 1000ml, 500ml, 300ml and 200ml.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Sterling Pharmaceuticals Ltd
288 Upper Balsall Heath Road
Moseley
Birmingham
B12 9DR
8 MARKETING AUTHORISATION NUMBER(S)
PL32515/0055
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 1996
10 DATE OF REVISION OF THE TEXT
11/08/2012