Lactulose Solution Bp
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1. Trade Name of the Medicinal Product
Lactulose Solution BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of solution contains Lactulose 3.35 g.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
A clear, viscous liquid, colourless or pale brownish yellow, miscible with water.
Clinical Particulars
4.1. Therap euti c Indi cati ons
Constipation, hepatic encephalopathy (portal systemic encephalopathy).
4.2 Posology and method of administration
For oral administration only
May be mixed with fruit juice, water or milk to increase palatability Constipation
Adults: initially 15ml twice daily. Dosage can often be gradually reduced to 10-20ml a day or every other day
Starting dose
Children 5 to 10 years: 10ml twice daily
Children under 5 years: 5ml twice daily
Babies: 2.5ml twice daily
Elderly: lactulose has been shown to be a suitable laxative for use in the elderly at the standard adult dose
Hepatic encephalopathy
Adults: initially 30 - 50ml (6 - 10 x 5ml spoonfuls) three times daily Dosage should be adjusted to produce two or three soft stools daily and an acidic faecal pH
Elderly: the standard adult dose is recommended Children: not recommended
Because of the physiological mode of action of lactulose it may take up to 48 hours before effects are obtained. However, clinical experience has shown that this medicament does exhibit a “carry-over” effect which may enable the patient to reduce the effective dose gradually over a period of time.
4.3. Contra-indications
Gastro-intestinal obstruction. This product is contra-indicated in patients who require a low-galactose diet.
4.4. Special Warnings and Precautions for Use
Dependence/Tolerance: Lactulose Solution does not lead to dependence, and increased tolerance is not a problem. Prolonged use of this product is not recommended except under medical supervision. The product contains a small amount of lactose (0.3 g/5 ml), therefore it should be used with caution in patients who are lactose intolerant.
A maintenance dose of 15 ml per day provides only 58 kJ (14 cals) and is therefore, unlikely to adversely affect diabetics.
Long term use of this product is inadvisable except under medical supervision.
4.5. Interactions with other Medicaments and other forms of Interaction
The elimination of certain colonic bacteria by broad spectrum anti-infective agents may interfere with the degradation of lactulose and prevent the acidification of colonic contents.
Pregnancy and lactation
4.6
Pregnancy: Clinical experience, together with data from animal reproduction studies has not revealed any increase in embryotoxic hazard to the foetus, if used in the recommended dosage during pregnancy. If drug therapy is needed during pregnancy, the use of this drug is acceptable.
Lactation: This product can be used by mothers during lactation.
4.7. Effects on Ability to Drive and Use Machines
Based on the pharmacodynamics of lactulose, it is unlikely that any adverse effects will occur.
4.8. Undesirable Effects
Flatulence and abdominal cramping. Excessive dosage can lead to diarrhoea. 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.
4.9 Overdose
There is little information on accidental overdose. It is expected that diarrhoea and abdominal cramps would be major symptoms. There is no specific antidote and symptomatic treatment should be given if required.
5.1. Pharmacodynamic properties
A06A D11 - Osmotically acting laxatives
Lactulose is a synthetic disaccharide analogue of lactose. There is no enzyme in the gastro-intestinal area capable of hydrolysing this disaccharide. In the colon lactulose is broken down by the colonic bacteria to low molecular weight acids that produce an increased osmotic pressure and slightly acidify the colonic contents, resulting in an increase in stool water and stool softening.
Furthermore since the colonic contents are then more acid than blood, ammonia can be expected to migrate from the blood into the colon. In the acidic environment NH3 is converted to (NH4)+, trapping it and preventing its absorption. This is what makes lactulose useful in hepatic encephalopathy.
5.2. Pharmacokinetic Properties
Given orally, only small amounts reach the blood, urinary excretion has been determined to be 3% or less, and is virtually complete within 24 hours.
Lactulose does not exert its effects until it reaches the colon. Therefore 24 to 48 hours may be required to produce normal bowel movement.
5.3. Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6.1. List of excipients
No added excipients. Lactulose Solution BP may however contain the following related substances:
|
Galactose |
nmt 15.0% |
|
Lactose |
nmt 10.0% |
|
Epilactose |
nmt 10.0% |
|
Tagatose |
nmt 4.0% |
|
Fructose |
nmt 1.0% |
of the lactulose content of the lactulose content of the lactulose content of the lactulose content of the lactulose content
(0.5025g/5ml)
(0.335g/5ml)
(0.335g/5ml)
(0.134g/5ml)
(0.0335g/5ml)
6.2. Incompatibilities
None known.
6.3. Shelf Life
2 years.
6.4. Special Precautions for Storage
Do not store above 25 °C. Do not refrigerate or freeze. Store in the original container.
Dilution and subsequent storage not recommended.
6.5. Nature and contents of container
Amber glass bottles with plastic screw caps of 200 ml, 300 ml and 500 ml.
HDPE bottles with plastic screw caps of 200 ml, 300 ml, 500 ml, 1000 ml and 5000 ml.
Not all pack sizes may be marketed.
6.6. Instruction for Use/Handling No special instructions.
Administrative Data
7. Marketing Authorisation Holder
Co-pharma Limited Unit 4
Metro Centre Tolpits Lane Watford Hertfordshire WD1 8SS United Kingdom
8. Marketing Authorisation Number
PL 13606/0084
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 15/01/2011
10 DATE OF REVISION OF THE TEXT
15/01/2011