1. Name Of The Medicinal Product
Lactugal.
2. Qualitative And Quantitative Composition
Active Ingredient:
Lactulose Solution BP 99.897 % v/v
(Equivalent to 62.0-74.0% w/v of Lactulose).
3. Pharmaceutical Form
Oral solution. Banana Flavour
4. Clinical Particulars
4.1 Therapeutic Indications
Constipation; Hepatic encephalopathy (Portal systemic encephalopathy).
4.2 Posology And Method Of Administration
For oral administration.
Adults:
Constipation: 15ml once or twice daily.
Hepatic Encephalopathy: Initially 30-50ml three times daily, adjust dose to produce 2 or 3 soft stools daily.
Children:
1-5 years: 5ml twice daily.
5-10 years: l0ml twice daily.
Elderly:
The normal adult dosage is appropriate.
4.3 Contraindications
Lactugal is contra-indicated where there is evidence of gastro-intestinal obstruction and to patients with galactosaemia.
4.4 Special Warnings And Precautions For Use
There are no warnings or precautions for patients with any impaired organ function.
Lactulose should be used with caution in patients exhibiting lactose intolerance.
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.
Lactulose solution has a calorific value of approximately 19Kcals/5mI. As, however, only negligible amounts of lactulose are absorbed from the gastrointestinal tract the available calories will be much lower than this, and therefore, is unlikely to adversely affect diabetes.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are no known interactions with lactulose.
4.6 Pregnancy And Lactation
Wide clinical experience in combination with data from animal production studies has not revealed any embryotoxic hazards to the foetus if used in the recommended dosage during pregnancy. If drug therapy is required during pregnancy or for lactating mothers, the use of this drug is acceptable.
4.7 Effects On Ability To Drive And Use Machines
There is no evidence to show that lactulose affects driving ability.
4.8 Undesirable Effects
A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals.
4.9 Overdose
If clinically important electrolyte disturbances occur, suitable corrective measures should be taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut.
Its mode of action in constipation is as an osmotic agent producing soft stools.
A dual mode of action is proposed for the efficacy of lactulose in Portal System Encephalopathy, relating to the metabolism of ammonia and subsequent nitrogenous toxins. The reduction in gastro-intestinal pH results in a net entrapment of ammonia in the gut lumen. Lactulose has also been shown to alter ammonia metabolism by microbial flora.
5.2 Pharmacokinetic Properties
Lactulose is absorbed from the gastro-intestinal tract to 0.4 - 2% and is excreted unchanged with the urine. There are no human lactulose disaccharide enzymes; metabolism of lactulose to lactic acid occurs via gastro-intestinal microbial flora only. Due to its poor bioavailability, plasma lactulose concentrations are negligible.
There are no known changes in kinetic properties in patients with organic diseases which may alter drug disposition.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Banana Flavour Quinoline Yellow
(17.41.0042) (E 1 04)
6.2 Incompatibilities
There are no known incompatibilities.
6.3 Shelf Life
36 months from the date of manufacture.
6.4 Special Precautions For Storage
Store at a temperature not exceeding 20°C. Do not freeze
6.5 Nature And Contents Of Container
Amber glass winchesters with polypropylene caps as closures. Polyethylene containers with polypropylene caps as closures.
6.6 Special Precautions For Disposal And Other Handling
There are no special storage or handling instructions for this product.
Administrative Data
7. Marketing Authorisation Holder
Intrapharm Laboratories Ltd
Maidstone
Kent
ME15 9QS
United Kingdom
8. Marketing Authorisation Number(S)
PL 17509/0011
9. Date Of First Authorisation/Renewal Of The Authorisation
4 September 2003
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