GUTCLEAR SYRUP

Indications

• Constipation
• Management of hepatic encephalopathy

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing information.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Lactitol exerts its pharmacologic effect by creating a hyperosmotic environment within the small intestine. This osmotic effect draws water into the intestinal lumen, loosening stools and facilitating bowel movements. It is metabolized by colonic bacteria, producing volatile fatty acids, and can lower colonic pH, similar to lactulose.

Pharmacodynamics

Lactitol facilitates bowel movements by increasing water content in the gastrointestinal tract. Its osmotic action is effective in treating constipation and may influence the colonic environment, which is beneficial in managing conditions like hepatic encephalopathy. Lactitol may also reduce the absorption of other oral medications, necessitating staggered administration.

Pharmacokinetics

Lactitol is minimally absorbed in the gastrointestinal tract, allowing it to act directly within the intestines. Its effects can be seen within 24 to 48 hours of administration. It does not significantly alter the systemic absorption of other medications, but it is advised to time their administration accordingly to avoid interaction.

Adverse effects

• Abdominal cramps
• Diarrhea
• Flatulence
• Nausea
• Vomiting

Interactions

• May reduce absorption of concomitant medications

Precautions

• Use with caution in patients with diabetes mellitus
• Monitor for electrolyte imbalances in patients with prolonged use

Pregnancy

Lactitol should only be used during pregnancy if clearly needed and after assessing the risks and benefits.

Breast-feeding

Lactitol is considered safe during breastfeeding, but consult a healthcare professional for individual cases.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of the reach of children.

Formulations

• Oral solution
• Granules for oral solution

Dosage

Children: Refer to specific drug formulations for paediatric dosing as monohydrate is not an active drug but a formulation type.

Adults: Refer to specific drug formulations for adult dosing as monohydrate is not an active drug but a formulation type.

Mechanism of action

Monohydrate itself does not have a specific mechanism of action as it is a formulation characteristic rather than an active ingredient. However, in the context of drugs that are formulated as monohydrates, the mechanism of action would depend on the active pharmaceutical ingredient (API) it is associated with.

Pharmacodynamics

The pharmacodynamics of monohydrates is also dependent on the API. Generally, the presence of water in monohydrated forms can enhance the dissolution rate and bioavailability of the drug, allowing for improved therapeutic effects.

Pharmacokinetics

The pharmacokinetics of drugs formulated as monohydrates can vary widely based on the characteristics of the active ingredient. In general, the absorption, distribution, metabolism, and excretion of the drug may be influenced by the solubility and stability provided by the monohydrate formulation.

Pregnancy

There is limited data on the use of monohydrate during pregnancy. Consultation with a healthcare provider is advised.

Breast-feeding

Monohydrate is generally considered safe during breastfeeding, but caution is advised. Consult a healthcare provider for specific concerns.

Storage

Store in a cool, dry place away from direct sunlight. Ensure the container is tightly closed to prevent moisture absorption.

Mechanism of action

Lactitol is an osmotic laxative - it exerts its pharmacologic effect by creating a hyperosmotic environment within the small intestine. The osmotic effect generated by lactitol draws water into the small intestine, which loosens stools and ultimately facilitates bowel movements. Lactitol, an unabsorbed sugar with defined laxative threshold and superior taste properties has been suggested as an alternative to lactulose in the treatment of hepatic encephalopathy. In the present study /investigators/ compared the colonic metabolism of the two sugars using an in vitro fecal incubation system. Both sugars were readily metabolized by fecal bacteria producing volatile fatty acids and the metabolism was inhibited by neomycin. The effect of lactitol and lactulose on terminal ileal and colonic pH was monitored in six normal subjects using a radiotelemetry technique. Both sugars significantly lowered right colonic pH (basal -6.51 +/- 0.48 vs lactitol -5.63 +/- 0.50; lactulose -5.18 +/- 0.82, p less than 0.05). The pH of rest of the colon and terminal ileum was unaffected. Neomycin given concurrently with lactulose abolished acidification of right colon. As lactitol and lactulose have similar effects within the colon, lactitol would appear to have a role in the treatment of hepatic encephalopathy. As neomycin antagonizes the effect of lactulose in the colon, its concurrent use may be less effective in the treatment of hepatic encephalopathy. ... Reports from authoritative bodies and reviews indicates that the decrease in pH in plaque as a consequence of metabolic acid production by saccharolytic bacteria when exposed to fermentable carbohydrates (i.e. sugars and starches) may promote demineralization and prevent remineralization of the hydroxyapatite crystals. Tooth hydroxyapatite crystals are very resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops. Typically, the critical pH for dental enamel is around 5.5. ... Demineralization of tooth tissues can also occur as a result of consumption of dietary acids in foods or beverages, and that frequent consumption can lead to dental erosion. Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose are slowly metabolized by bacteria in the mouth. The rate and amount of acid production from these food constituents is significantly less than that from sucrose. ... Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose do not promote dental caries because they do not lower plaque pH to the level associated with enamel demineralization. ... A cause and effect relationship has been established between the consumption of sugar-containing foods/drinks at an exposure frequency of four times daily or more and an increased tooth demineralization, and that the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, instead of sugar in sugar-containing foods/drinks, may maintain tooth mineralization by decreasing tooth demineralization compared with sugar-containing foods, provided that such foods/drinks do not lead to dental erosion. The food constituents xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose resulted in reduced post-prandial blood glucose (or insulinemic) responses compared with sugars on a weight by weight basis owing to their reduced/delayed digestion/absorption and/or to a decrease in the amount of available carbohydrates, and that the consumption of foods/drinks in which xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose replaced sugars induced lower post-prandial glycemic and insulinemic responses than sugar-containing foods/drinks. ... A cause and effect relationship has

Pharmacodynamics

Lactitol helps to facilitate bowel movements by drawing water into the gastrointestinal tract. The oral administration of lactitol may reduce the absorption of concomitant medications - other oral medications should be administered at least 2 hours before or 2 hours after lactitol.