Lactulose

Registered South African indications:

• Constipation
  - Particularly in association with laxative habituation
  - In post-surgical and obstetric patients
• Hyperammonaemia associated with portal system encephalopathy
  - In patients with chronic hepatic encephalopathy, including stages of hepatic pre-coma and coma

Contraindications

South African recommendations

Oral (pdr, sol)

• Patients with known hypersensitivity to lactulose or to any of the excipients used in the formulation
• Abdominal obstruction
• Appendicitis
• Undiagnosed rectal bleeding
• Congestive heart failure
• Hypertension
• Galactosaemia including patients on a low galactose diet should not use lactulose
• Hyperosmotic laxatives should not be prescribed to colostomy or ileostomy patients

Oral (syr)

• Hypersensitivity to lactulose
• Galactosaemia
• Gastrointestinal obstruction
• Perforation in the digestive organs or risk of this (for example, acute inflammatory diseases of the intestine, such as colitis ulcerosa, Crohn’s disease)

Recommendations in other jurisdictions

Oral (sol)

• Hypersensitivity to the active substance or any of the excipients
• Galactosaemia
• Gastro-intestinal obstruction
• Perforation or risk of perforation

Cautions

• Painful abdominal symptoms of undetermined cause before the treatment is started
• Children
• Diabetes mellitus
• Chronic use
• Lactose intolerance
• Galactose intolerance
• Fructose intolerance
• Lapp lactase deficiency 
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: pdr, sol, syr

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Constipation
- Particularly in association with laxative habituation
- In post-surgical and obstetric patients

• Oral (pdr): Initial: 10-30g/day, in 1-2 divided doses for 3 days; Maintenance: Adjust according to patient's needs; Dosage may be increased to 40g, dly if there is no response
• Oral (sol, syr): Initial: 19.8g (30ml), dly for 3 days; Maintenance: 9.9-19.8g (15-30ml), dly

Hyperammonaemia associated with portal system encephalopathy
- In patients with chronic hepatic encephalopathy, including stages of hepatic pre-coma and coma

• Oral (pdr): Initial: 60-120g/day, in 3-4 divided doses; Maintenance: Adjusted to produce 2-3 soft stools, dly
• Oral (sol, syr): Initial: 19.8-33g (30ml-50ml), 8hrly; Maintenance: Adjusted to produce 2-3 soft stools, dly

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For all indications: An effect may only be obtained after 24-48hrs

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Method of administration: The sachet (pdr) can be taken with drinks e.g., tea, coffee, fruit juice or milk, or with breakfast cereals. Drink a full glass of liquid or more, with each dose of the sachet (pdr)
The syrup needs to be taken, preferably after breakfast

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Indications and dosages registered in other jurisdictions

Constipation

• Oral (sol): Initial: 10.005-30.015g (15-45ml)/day, in 1-2 divided doses; Maintenance: 10.005-20.01g (15-30ml)/day, in 1-2 divided doses, based upon treatment response

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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

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Hepatic encephalopathy

• Oral (sol): Initial: 20.01-30.015g (30-45ml), 6-8hrly; Maintenance: Adjusted to produce 2-3 soft stools dly

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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

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The posology should be adjusted according to the individual needs of the patient. 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

Paed. forms avail. in SA and covered in this monograph: pdr, syr, sol

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Constipation
- Particularly in association with laxative habituation
- In post-surgical and obstetric patients, as well as children

Oral (pdr)

• Younger than 1 year: No information available
• Between 1-6 years: Initial: 5-10g, dly; Maintenance: Adjust according to individual response
• Between 7-14 years: Initial: 10g, dly; Maintenance: Adjust according to individual response
• Older than 14 years: See adult dosage

Oral (sol, syr)

• Younger than 1 year (infants): Initial: 3.3g (5ml), dly for 3 days; Maintenance: 1.65-3.3g (2.5-5ml), dly
• Between 1-5 years: Initial: 6.6g (10ml), dly for 3 days; Maintenance: 3.3-6.6g (5-10ml), dly
• Between 6-14 years: Initial: 9.9g (15ml), dly for 3 days; Maintenance: 6.6-9.9g (10-15ml), dly
• Older than 14 years: See adult dosage

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For all indications: An effect may only be obtained after 24-48hrs

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Method of administration: The sachet (pdr) can be taken with drinks e.g., tea, coffee, fruit juice or milk, or with breakfast cereals. Drink a full glass of liquid or more, with each dose of the sachet (pdr)
The syrup needs to be taken, preferably after breakfast

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Indications and dosages registered in other jurisdictions

Constipation

Oral (sol)

• Younger than 1 year: Initial: Up to 3.335g (5ml)/day, in 1-2 divided doses; Maintenance: Up to 3.335g (5ml)/day, in 1-2 divided doses based upon treatment response
• Between 1-6 years: Initial: 3.335-6.67g (5-10ml)/day, in 1-2 divided doses; Maintenance: 3.335-6.67g (5-10ml)/day, in 1-2 divided doses based upon treatment response
• Between 7-14 years: Initial: 10.005g (15ml)/day, in 1-2 divided doses; Maintenance: 6.67- 10.005g (10-15ml)/day, in 1-2 divided doses, based upon treatment response
• Older than 14 years: See adult dosage

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The safety and efficacy in children (newborn to 18 years of age) with hepatic encephalopathy (HE) have not been established. No data are available

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For a precise dosing for infants and children up to 7 years lactulose in bottles should be used

Pregnancy 

• Safe
• No effects during pregnancy are anticipated since systemic exposure to lactulose is negligible

Breastfeeding 

• Compatible
• No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to lactulose is negligible

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended

Elderly 

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Diarrhoea
• Flatulence
• Abdominal pain
• Nausea and vomiting

Endocrine and Metabolic Disorders 

• Electrolyte imbalances

No information available

None routine 

Lactulose is broken down by colonic bacteria into low molecular organic acids in the colon. These acids lead to a lowering of pH which produces an osmotic effect in the colon, resulting in increased faecal bulk and stimulation of colonic peristalsis. Constipation is relieved and the physiological rhythm of the colon is reinstated. In hepatic encephalopathy, the increased acid production of larger doses of lactulose reduces the pH in the colon significantly and the absorption of ammonium ions and other toxic nitrogenous compounds are decreased leading to a fall in blood ammonium levels.

Lactulose is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Syrup (per 5ml) 3.3g

• Aculax (Actavis)
• Duphalac (Abbott)
• Lacson (Aspen)

Solution (per 5ml) 3.3g

• Laxette (Cipla)

Sachet 10g

• Duphalac dry (Solvay)
• Laxette dry (Cipla)