Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berkshire SL6 6PT, United Kingdom
Constipation; hepatic encephalopathy (portal systemic encephalopathy).
For oral administration.
The lactulose solution may be administered diluted or undiluted. Each dose may, if necessary, be taken with water or fruit juices etc.
Each dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
All dosages should be adjusted to the needs of the individual.
In case of single daily dose, this should be taken at the same time, e.g. during breakfast.
During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 litres, equal to 6-8 glasses) during the day.
Lactulose may be given as a single daily dose or in two divided doses.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs.
| Starting dose daily | Maintenance dose daily | |
|---|---|---|
| Adults and adolescents | 15-45 ml | 15-30 ml |
| Children (7-14 years) | 15 ml | 10-15 ml |
| Children (1-6 years) | 5-10 ml | 5-10 ml |
| Infants under 1 year | Up to 5 ml | Up to 5 ml |
Starting dose: 3 to 4 times daily 30-45ml (6-9 × 5ml spoonfuls). This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day.
The safety and efficacy in children (newborn to 18 years of age) with Hepatic Encephalopathy have not been established. No data are available.
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
If the dose is too high, the following may occur: diarrhoea and abdominal pain
A dose reduction or cessation of therapy should be considered. Excessive fluid loss due to diarrhoea or vomiting may result in clinically important electrolyte disturbances, and suitable corrective measures should be taken.
There is no specific antidote and supportive, symptomatic treatment should be given.
36 months from the date of manufacture.
Store at a temperature not exceeding 20°C. Do not freeze.
Amber glass winchesters with polypropylene caps as closures: pack sizes 300 ml, 500 ml, 1000 ml and 2000 ml.
Polyethylene containers with polypropylene caps as closures: pack sizes 250 ml, 300 ml, 500 ml, 1000 ml and 2000 ml.
Not all pack sizes may be marketed.
There are no special storage or handling instructions for this product.
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