Lactulose solution may be administered diluted or undiluted.
The posology should be adjusted according to the individual needs of the patient.
A single dose of lactulose should be swallowed in one, and should not be kept in the mouth for an extended period of time.
In case of single daily dose is prescribed, this should be taken at the same time, e.g. during breakfast. During the therapy with laxatives it is recommended sufficient amounts of fluids (1.5 - 2 litres, equal to 6 - 8 glasses) during the day.
For Duphalac in bottles the measuring cup may be used.
For Duphalac in 15 ml single dose sachets the corner of the sachet should be torn off and contents taken immediately.
Dosing in constipation or where soft stool is considered of medical benefit: Lactulose may be taken as a single daily dose or in two divided doses; for Duphalac in bottles the measuring cup may be used.
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. (See Table 1.)
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For a precise dosing for infants and children up to 7 years Duphalac in bottles should be used.
Syrup: Adults and Adolescents:
Starting Dose: 10-45 mL. Maintenance Dose: 10-25 mL.
Children 7-14 years:
Starting dose: 15 mL. Maintenance Dose: 10-15 mL.
Dosing in HE (for adults only): For oral administration: Starting dose: 3 to 4 times daily 20-30 g (2-3 sachets) or 30-45 ml (2-3 sachets).
This dose may be adjusted to the maintenance dose to achieve 2 to 3 soft stools per day.
For rectal administration: In acute cases (impending coma or coma stage) Duphalac may be administered as a retention enema (300 ml Duphalac/700 ml water). The enema is to be retained for 30-60 minutes; the procedure is to be repeated every 4-6 hrs until oral medication can be administered.
The safety and efficacy in children (newborn to 18 years of age) with HE have not been established. No data are available.
Elderly patients and patients with renal or hepatic insufficiency:
No special dosage recommendations exist, since systemic exposure to lactulose is negligible.