MiraLAX (Polyethylene Glycol 3350 - OTC) Drug Information: Clinical Pharmacology

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May 27, 2012

MiraLAX

Constipation »

Constipation facts

Constipation is defined medically as fewer than three stools per week and severe constipation as less than one stool per week.
Constipation usually is caused by the slow movement of stool through the colon.
There are many causes of constipation including medications, poor bowel habits, low fiber diets, abuse of laxatives, hormonal disorders, and diseases primarily of other parts of the body that also affect the colon.
The two disorders limited to the colon that cause constipation are colonic inertia and pelvic floor dysfunction.
Medical evaluation for the cause of constipation should be done when constipation is of sudden onset, severe, worsening, associated with other worrisome symptoms such as loss of weight, or is not responding to simple, safe treatments.
Medical evaluation of constipation may include a history, physical examinatio...

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MiraLAX User Reviews >>

MiraLAX

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CLINICAL PHARMACOLOGY

Pharmacology: MiraLax (polyethylene glycol 3350 - otc) is as osmotic agent which causes water to be retained with the stool.

Essentially, complete recovery of MiraLax (polyethylene glycol 3350 - otc) was shown in normal subjects without constipation. Attempts at recovery of MiraLax (polyethylene glycol 3350 - otc) in constipated patients resulted in incomplete and highly variable recovery. In vitro study showed indirectly that MiraLax (polyethylene glycol 3350 - otc) was not fermented into hydrogen or methane by the colonic microflora in human feces. MiraLax (polyethylene glycol 3350 - otc) appears to have no effect on the active absorption or secretion of glucose or electrolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALS

There have been several key clinical studies involving MiraLAX (polyethylene glycol 3350 - otc) .

Reference 1

Efficacy and Safety of Traditional Medical Therapies for Chronic Constipation: Systematic Review.

Ramkumar D et al. Am J Gastroenterol. 2005;100:936-971.

The results of 37 years of clinical trials evaluating the safety and efficacy of laxatives were studied and compared to make guideline recommendations for their use
The best evidence found supports the use of polyethylene glycol (MiraLAX (polyethylene glycol 3350 - otc) ) and tegaserod
Considerable evidence also supported the use of psyllium and lactulose

Study 1

New Polyethylene Glycol Laxative for Treatment of Constipation in Adults: A Randomized, Double-Blind, Placebo-Controlled Study.

Cleveland MV et al. South Med J. 2001;94:478-481.

Evaluated the safety and effectiveness of MiraLAX (polyethylene glycol 3350 - otc) in people with constipation
23 patients with constipation were given the normal daily dose (17 grams) of MiraLAX (polyethylene glycol 3350 - otc) or a placebo and were watched for any changes in how often they had bowel movements
After 14 days, patients given MiraLAX (polyethylene glycol 3350 - otc) had significantly (P=.0001) more bowel movements than those on placebo, and they had no serious side effects

Study 2

An Efficacy and Consumer Preference Study of Polyethylene Glycol 3350 for the Treatment of Constipation in Regular Laxative Users.

Data on File.

74 patients with constipation used MiraLAX (polyethylene glycol 3350 - otc) instead of their usual laxative for up to 2 weeks
Number of bowel movements nearly doubled with MiraLAX (polyethylene glycol 3350 - otc) , while there was less complaint of gas and bloating
More than two thirds of patients in this study preferred MiraLAX (polyethylene glycol 3350 - otc) to their usual laxative

Study 3

A Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of a New Polyethylene Glycol Laxative.

DiPalma JA et al. Am J Gastroenterol. 2000;95:446-450.

Evaluated the safety and effectiveness of MiraLAX (polyethylene glycol 3350 - otc) in 151 people with constipation
Patients were given either MiraLAX (polyethylene glycol 3350 - otc) or a placebo, and kept track of any changes in how often they had bowel movements as well as changes to the bowel movement itself
After 2 weeks, patients who took MiraLAX (polyethylene glycol 3350 - otc) had significantly (P<.001) more bowel movements than those who were given a placebo, and also had less cramping and gas

Study 4

Braintree Polyethylene Glycol (PEG) Laxative for Ambulatory and Long-Term Care Facility Constipation Patients.

DiPalma JA et al. Online Journal of Digestive Health. 1999;1(2).

Evaluated the safety and effectiveness of MiraLAX (polyethylene glycol 3350 - otc) in 50 people with constipation who were either ambulatory outpatients or living in long-term care facilities
Patients received placebo or a high (34 grams) or low (17 grams) dose of MiraLAX (polyethylene glycol 3350 - otc) (later reduced to 12 and 6 grams, respectively, in long-term care patients)
All patients given MiraLAX (polyethylene glycol 3350 - otc) had increases in how often they had bowel movements and improvement in the quality of the bowel movement, with no severe side effects
The higher doses of MiraLAX (polyethylene glycol 3350 - otc) yielded better bowel movements more often versus lower doses, and people given either dose of MiraLAX (polyethylene glycol 3350 - otc) had better outcomes than those on placebo

Last reviewed on RxList: 7/25/2007
This monograph has been modified to include the generic and brand name in many instances.