Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Constipation.
Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma.
The lactulose solution may be administered diluted or undiluted.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient. In case of a 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 |
Oral use.
For Duphalac in bottles the measuring cup may be used to administer the appropriate dose.
For oral administration.
| Starting Dose | Maintenance Dose |
| 3 to 4 times daily 30-45 ml | Starting dose may be adjusted to the maintenance dose to achieve 2-3 soft stools per day |
The safety and efficacy of Duphalac in children (newborn to 18 years of age) with Hepatic Encephalopathy have not been established. No data is available.
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.
If the dose is too high the following may occur:
Symptom: diarrhoea, loss of electrolytes and abdominal pain.
Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Three years.
This medicinal product does not require any special storage conditions.
Opaque white multidose bottles of HDPE with a polypropylene screw cap containing 300 or 1000 ml, with a polypropylene measuring cup.
The graduations on the measuring cup are: 2.5ml, 5ml, 10ml, 15ml, 20ml, 25ml and 30ml.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
