Lactulose Solution Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Solution BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of Lactulose Solution contains 3.4g of lactulose.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Liquid for oral use.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Constipation; hepatic encephalopathy (portal systemic encephalopathy).
4.2 Posology and method of administration Constipation:
Adults: Initially 15ml twice daily.
Children: 1 to 5 years - 5ml twice daily.
5 to 10 years - 10ml twice daily.
Dosage may vary depending on the condition. The above dosage serves as a
guide. Eventually the dose should be adjusted, usually reduced to meet the needs of the individual.
Initially 30ml to 50ml, 3 times daily; adjust dose to produce 2 or 3 soft stools daily.
Method of administration: Oral.
4.3 Contraindications
Contraindicated where there is evidence of gastrointestinal obstruction and in patients who require a galactose-free diet.
4.4 Special warnings and precautions for use
The product should be administered with care to patients who are intolerant to lactose.
Due to the product’s physiological mode of action it may take up to 48 hours before effects are obtained, however the product does exhibit a “carry-over” effect which may enable the patient to reduce the dose gradually over a period of time.
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable.
4.6 Pregnancy and lactation
The product should only be administered on the advice of a physician during pregnancy or lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
Undesirable effects
4.8
In the event of diarrhoea, adequate fluid intake should be maintained during treatment and the dosage reduced to prevent loss of fluid and potassium and exacerbation of encephalopathy. The product may give rise temporarily to flatulence and abdominal cramping.
4.9 Overdose
Patients should be given plenty of fluids. An anticholinergic preparation such as atropine methonitrate would help to offset the excessive intestinal motility.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The action of lactulose in treating constipation depends on the inability of the enzymes in the small intestine to hydrolyse the synthetic disaccharide, lactulose, into its component molecules of fructose and galactose. Therefore, as lactulose in virtually unabsorbed, it passes into the large bowel chemically unchanged and forms a substrate for commensal saccharolytic bacteria.
The resulting breakdown products, simple organic compounds like lactic and acetic acid, give rise to increased intra-colonic osmotic pressure, with consequent increased faecal bulk, and stimulate peristalsis. The growth of the saccharolytic bacteria is favoured and the normal colonic flora restored.
A soft stool is formed and normal bowel action encouraged without irritation or direct interference with the gut mucosa.
In patients with hepatic encephalopathy larger doses of lactulose are used; a significant reduction in the pH of the colonic contents results, which reduces markedly the formation and absorption of ammonium ions and other nitrogenous toxins into the portal circulation. Rapid decrements in blood ammonia concentration have been reported following lactulose treatment.
5.2 Pharmacokinetic properties
No pharmacokinetic particulars are presented as lactulose is not absorbed by the body.
5.3 Preclinical safety data
Not required.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose, D-galactose, fructose, D-tagatose and epilactose.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Glass bottles: 36 months unopened and 36 months after opening.
HDPE bottles: 24 months unopened and 24 months after opening.
6.4 Special precautions for storage
Glass bottles: Store below 20oC. Do not freeze.
HDPE bottles: Store below 25°C. Do not freeze.
Nature and contents of container
6.5
Amber glass Winchesters, with polypropylene caps as closures. Pack sizes: 300ml and 1,000ml;
or
Opaque, high density polyethylene bottles (square cross section or circular cross section).
Pack sizes: 200ml, 300ml, 500ml and 1,000ml.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Sandoz Limited Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04416/0218
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/04/1992 / 30/04/2003 04/08/2011