Lactulose

Product: Duphalac 3.335 g/5 mL Oral Solution (lactulose), UK SPC https://www.medicines.org.uk/emc/product/5525/smpc. The posology should be adjusted according to the individual needs of the patient. After a few days the starting dose may be adjusted to the maintenance dose based on treatment response; several days (2-3 days) of treatment may be needed before the effect occurs. During laxative therapy it is recommended to drink sufficient fluid (1.5-2 litres, equal to 6-8 glasses) during the day. If the therapeutic effect is insufficient after several days, reconsider the dose and/or additional measures. Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of electrolyte balance, and the defaecation reflex may be disturbed during treatment. SECOND INDICATION — HEPATIC ENCEPHALOPATHY (adults, same UK SPC §4.2, oral route): starting dose 30-45 mL (6-9 x 5 mL spoonfuls) or 2-3 sachets, 3 to 4 times daily; this dose may then be adjusted to the maintenance dose to achieve two or three soft stools each day. If these high doses are used for an extended period the patient may develop electrolyte imbalance due to diarrhoea — adjust the dose to obtain two or three formed stools per day. The dose normally used in constipation should not pose a problem for diabetics, but the much higher dose used in hepatic encephalopathy may need to be taken into consideration for diabetics. (The US label additionally describes a RECTAL retention-enema route for the impending-coma or coma stage of portal-systemic encephalopathy where there is a danger of aspiration; that is a different route and is not carried on this oral page — clinician to source it separately if the page should cover it.) PAEDIATRIC (UK SPC §4.2 — volume bands, not per-kg, hence paedDose is null): constipation — children 7-14 years, starting 15 mL daily (1 sachet), maintenance 10-15 mL daily; children 1-6 years, 5-10 mL daily starting and maintenance; infants under 1 year, up to 5 mL daily starting and maintenance. If the maintenance dose is below 15 mL, the bottle presentation should be used, and for precise dosing in infants and children up to 7 years the bottle should be used. Safety and efficacy in children (newborn to 18 years) with hepatic encephalopathy have NOT been established and no data are available. Use of laxatives in children should be exceptional and under medical supervision. Verify paediatric dosing against a children's formulary. EXCIPIENT WARNING: this product contains lactose, galactose and fructose from the route of production — patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take it, and it should be given with care to patients intolerant to lactose; it also contains sulphite from the route of production.