Lactulose Solution Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Solution BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 68.0 % w/v For excipients, see 6.1
3 PHARMACEUTICAL FORM
Liquid for oral use
A clear, colourless to brownish yellow liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Lactulose is used in the treatment of constipation and in the management of ammonia intoxication associated with encephalopathy associated with hepatic failure.
4.2 Posology and method of administration For oral administration.
As a Laxative:
Initially 15ml to 30ml lactulose in divided doses each day for two to
three days.
Maintenance 10ml to 15ml lactulose in divided doses each day. The dose should reflect the patient’s response.
Children Under one year 2.5ml, 1-5 years 5ml twice daily, 5-10 years
10ml twice daily..
Elderly The normal adult dose may be given.
As an adjunct in the management of hepatic encephalopathy:
Initially: 30ml to 50ml three times a day, subsequently adjusted to
produce two to three soft stools daily.
Children There are insufficient data to support definitive guidelines.
Elderly The dosage should be adjusted according to the clinical
situation.
Lactulose has a bland taste and may be given with water or fruit juice.
4.3. Contraindications
Lactulose solution should not be given to patients with galactosaemia, intestinal obstruction, or to those who are on a low galactose diet.
4.4 Special warnings and precautions for use
Lactulose solution should be given with caution to patients with diabetes mellitus or to those who are lactose-intolerant.
As with any laxative, excessive use may cause loss of electrolytes
especially in the elderly, children and debilitated patients. Habitual use should be
discouraged.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
As lactulose is not absorbed, systemic drug interactions are unlikely. It has been reported that lactulose possibly enhances the anticoagulant effect of coumarins.
4.6 Fertility, pregnancy and lactation
Pregnancy
Limited data on pregnant patients indicate neither malformative nor foeto/neonatal toxicity.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
The use of lactulose may be considered during pregnancy if necessary.
Lactation
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Lactulose can be used during breast-feeding.
4.7 Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Gastrointestinal Disorders: Lactulose may cause nausea and vomiting, and abdominal discomfort associated with flatulence and cramps. Diarrhoea may occur in patients taking standard or large doses, and may result in loss of water and electrolyte imbalance (hypernatraemia and hypokalaemia).
4.9 Overdose
Overdosage with lactulose would be expected to be manifested as nausea, vomiting and diarrhoea. Treatment should be symptomatic. Any deficit in hydration or electrolyte imbalance should be corrected.
5.1 Pharmacodynamic properties
Lactulose is a synthetic acid disaccharide which is not significantly absorbed from the gastrointestinal tract. It has an essentially local action providing a substrate for saccharolytic bacteria in the gut. The lactic and acetic acid metabolites produced stimulate peristalsis and have an osmotic action, softening faeces.
5.2 Pharmacokinetic properties
Lactulose is not significantly absorbed from the gastrointestinal tract. Its rate of metabolism (in the lumen of the gut) and hence its laxative effects will depend on the activity of the saccharolytic bacteria present.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water.
6.2 Incompatibilities
None stated.
6.3
Shelf life
24 months.
6.4 Special precautions for storage
Store below 20°C.
Store in the original container
6.5 Nature and contents of container
Glass bottles (amber) with low density polyethylene caps and HDPE bottles with HDPE caps. Pack sizes of 300ml, 500ml and 1000ml.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0269
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation - 17 November 1988
Date of renewal - 17 November 1993 and 19 November 1998
10 DATE OF REVISION OF THE TEXT
20/06/2013