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Miralax (Polyethylene Glycol 3350 Powder) - Description and Clinical Pharmacology

 
 



DESCRIPTION

A white powder for reconstitution. MiraLax (polyethylene glycol 3350, NF powder for solution) is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. MiraLax is an osmotic agent for the treatment of constipation.

CLINICAL PHARMACOLOGY

Pharmacology:    MiraLax is an osmotic agent which causes water to be retained with the stool. Essentially, complete recovery of MiraLax was shown in normal subjects without constipation. Attempts at recovery of MiraLax in constipated patients resulted in incomplete and highly variable recovery. In vitro study showed indirectly that MiraLax was not fermented into hydrogen or methane by the colonic microflora in human feces. MiraLax appears to have no effect on the active absorption or secretion of glucose or electrolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALS

In one study, patients with less than 3 bowel movements per week were randomized to MiraLax, 17 grams, or placebo for 14 days. An increase in bowel movement frequency was observed for both treatment groups during the first week of treatment. MiraLax was statistically superior to placebo during the second week of treatment.

In another study, patients with 3 bowel movements or less per week and/or less than 300 grams of stool per week were randomized to 2 dose levels of MiraLax or placebo for 10 days each. Success was defined by an increase in both bowel movement frequency and daily stool weight. For both parameters, superiority of the 17 gram dose of MiraLax over placebo was demonstrated.

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