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Lactulose + Paraffin

Development stage
Unknown
Administration
Oral
01

Overview

Lactulose + paraffin is a combination medication used primarily for treating functional constipation. This combination leverages the complementary mechanisms of both components to provide effective relief from constipation symptoms. ## Composition and Mechanism The combination contains lactulose, a synthetic sugar that works as an osmotic laxative, and paraffin (also known as liquid paraffin), which acts as a lubricant laxative. In this formulation, micronized particles of lactulose are coated with a protective paraffin layer that has a melting point of 35°C to 40°C[7]. This design allows for the gradual release of lactulose in the colon as the paraffin dissolves. The dual mechanism provides two distinct benefits: - Lactulose increases water content in the large bowel through osmotic action - Paraffin provides lubrication and emulsification of the fecal mass This combination improves symptoms related to both proximal colonic transit and distal evacuation[7]. ## Clinical Efficacy A randomized, parallel-group, multicentre phase 4 study compared lactulose plus paraffin with polyethylene glycol (PEG) in 363 patients with functional constipation. The results established non-inferiority of lactulose plus paraffin compared to PEG, with both treatments significantly decreasing the Patient Assessment of Constipation-Symptoms (PAC-SYM) score from baseline[6][8]. ## Safety Profile The safety profile of lactulose plus paraffin appears favorable. In clinical studies, adverse events occurred in 11.2% of patients taking lactulose plus paraffin compared to 14.2% in the polyethylene glycol group. Most adverse events were mild or moderate in severity and unrelated to the study drugs[6][8]. The combination formulation with lower doses of lactulose and paraffin provides equivalent laxative activity while reducing the side effects typically associated with lactulose alone (bloating, gas, and abdominal pain)[7]. ## Brand Names The combination is marketed under the brand name Melaxose[6][7]. ## Usage and Indications Lactulose plus paraffin is indicated for the treatment of functional constipation in adults. Based on clinical evidence, it may be used interchangeably with polyethylene glycol for this purpose[6][8]. The combination is particularly beneficial as it addresses both the water content in the bowel and provides lubrication, making it effective for various types of constipation.

Brand names
Melaxose
02

Targets

Colonic luminal water and osmolarity

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