(British Approved Name, rINN)
Pharmacopoeias. In USNF. Europe includes the monohydrate.
European Pharmacopoeia, 6th ed. (Lactitol Monohydrate). A white or almost white crystalline powder. Very soluble in water slightly soluble in alcohol practically insoluble in dichloromethane.
The United States Pharmacopeia 31, 2008, and Supplements 1 and 2 (Lactitol). It may be the anhydrous form, the monohydrate, or the dihydrate. White or light brown, odourless, crystals. It has a mild, sweet taste, and no aftertaste.
Lactitol is a disaccharide analogue of lactulose (below) and has similar actions and uses.
Lactitol monohydrate is used as an oral powder or solution in the management of hepatic encephalopathy and in constipation. Lactitol monohydrate 1.05 g is equivalent to about 1 g of anhydrous lactitol.
In the treatment of hepatic encephalopathy, lactitol monohydrate is given in usual oral doses of 500 to 700 mg/kg daily in 3 divided doses at meal times. The dose is subsequently adjusted to produce 2 soft stools daily.
In the treatment of constipation, lactitol monohydrate is given in an initial dose of 20 g daily as a single dose with the morning or evening meal, subsequently adjusted to produce one stool daily. A dose of 10 g daily may be sufficient for many patients. Doses should be mixed with food or liquid, and 1 to 2 glasses of liquid should be drunk with the meal. Lactitol is a permitted sweetener in foods.
Austria: Importal Neda-Lactitol Portolac †
Belgium: Importal Normolaxil Portolac
Czech Republic: Importal †
Israel: Importal † Novolax
The Netherlands: Importal
Norway: Importal †
New Zealand: Importal
Spain: Emportal Opona †