MiraLAX® — doctor recommended, patient approved
MiraLAX® is the ONLY OTC osmotic laxative with a prescription heritage and is favored by both physicians and patients1
MiraLAX® is supported by 19 years of safe and effective use.
FDA-approved as an OTC product in 2006
MiraLAX® provides predictable and reliable relief for a broad range of patients
WOMEN AND MEN
17 years of age and older4
ELDERLY PATIENTS
65 years of age and older5
PATIENTS TAKING CONSTIPATION-CAUSING MEDICATIONS6
PATIENTS ON OTHER MEDICATIONS
No known drug-to-drug interactions
Feel confident recommending MiraLAX® for gentle relief of occasional constipation
References: 1. Food and Drug Administration. Approval letter for new drug application for MiraLAX® powder;February 18, 1999;Rockville, Maryland. . 2. Bharucha AE, Dorn SD, Lembo A, Pressman A;
American Gastroenterological Association. American Gastroenterological Association medical position statement on constipation.Gastroenterology. 2013;144(1):211-217. 3. Survey of 672 consumers, August 2017, Bayer Consumer Health. 4. MiraLAX® Drug Facts. Bayer HealthCare. 5. DiPalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for
chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102(7);1436-1441. 6. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090.
MiraLAX® works differently to provide
predictable relief
The gentle power of MiraLAX® softens stool and relieves constipation1-5
In multiple clinical trials, MiraLAX® has been proven to
Result in a bowel movement within 24 to 72 hours8
Significantly increase the frequency of bowel movements vs placebo3-5
References: 1. Hammer HF, Santa Ana CA, Schiller LR, Fordtran JS. Studies of osmotic diarrhea induced in normal subjects by ingestion of polyethylene glycol and lactulose. J Clin Invest. 1989;84(4):1056-1062. doi:10.1172/JCl114267 2. Schiller LR, Emmett M, Santa Ana CA, Fordtran JS. Osmotic effects of polyethylene glycol. Gastroenterology. 1988;94(4):933-941. 3. DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-450. 4. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090. 5. Cleveland MV, Flavin DP, Ruben RA, Epstein RM, Clark GE. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J. 2001;94(5):478-481. 6. Bassotti G, Chiarioni G, Germani U, Battaglia E, Vantini I, Morelli A. Endoluminal instillation of bisacodyl in patients with severe (slow transit type) constipation is useful to test residual colonic propulsive activity. Digestion. 1999;60(1):69-73. 7. Frexinos J, Staumont G, Fioramonti J, Bueno L. Effects of sennosides on colonic myoelectrical activity in man. Dig Dis Sci. 1989;34(2):214-219. 8. MiraLAX® [drug facts]. Bayer HealthCare.
Summary of key MiraLAX® clinical studies
and analyses
MiraLAX® is supported by 19 years of safe and effective use
- Evaluated the safety and effectiveness of MiraLAX® in 151 people with constipation
- Patients were given either MiraLAX® or a placebo, and kept track of any changes in how often they had bowel movements as well as associated subjective symptoms.
- After 2 weeks, patients who took MiraLAX® had significantly (P<0.001) more bowel movements as well as significantly less severe cramping and gas (P<0.001).
- Evaluated the safety and effectiveness of MiraLAX® laxative in people with constipation
- Twenty-three patients with constipation were given the normal daily dose (17 g) of MiraLAX® or a placebo, after which they recorded each bowel movement and associated symptoms in a diary and watched for any changes in how often they had bowel movements.
- After 14 days, patients given MiraLAX® had significantly more bowel movements than those on placebo (7.0 vs 3.6, respectively, in week 2; P<0.001), and they had no serious side effects.
- Randomized clinical trials conducted between 1966 and 2003 were identified to evaluate the safety and efficacy of different laxatives.
- Polyethylene glycol received Level 1, Grade A ratings.
- Level 1: Consistent results from well-designed, well-conducted studies
- Grade A ratings for efficacy and safety: Good evidence in support of the use of a modality in the treatment of constipation
- Patients taking constipation-inducing medications (≥3% incidence of constipation) were randomized to treatment with 17 g PEG 3350 (n=50) daily or placebo (n=50) for 28 days.
- The primary efficacy variable of treatment success was based on the presence of no more than one of the following in 25% of bowel movements or <3 bowel movements per week over the last 7 days of treatment:
- Straining
- Lumpy/hard stool
- Incomplete evacuation
- Anorectal obstruction
- Manual maneuvers
- PEG 3350 was significantly superior vs placebo in the primary efficacy endpoint of treatment success: 78.3% vs 39.1% (P<0.001), respectively.
- Statistically significant difference in favor of PEG 3350 over placebo were observed:
- After first week of treatment:
- Total number of bowel movements per week
- Number of complete bowel movements
- Number of satisfactory bowel movements
- For all treatment weeks:
- Straining
- Stool consistency
- There were no statistically significant treatment-emergent adverse events, including GI complaints.
- After first week of treatment:
- Patients with modified Rome functional constipation criteria of <3 satisfactory bowel movements per week, with straining in >25% of defecations, hard or lumpy stools in >25% of defecations, or sensation of incomplete evacuation in >25% of defecations for a 3-month period were randomized to treatment with 17 g PEG 3350 (n=204) daily or placebo (n=100).
- The primary efficacy variable of treatment success was defined as no rescue laxative use, ≥3 satisfactory stools per week, and ≤1 remaining symptom of the modified Rome criteria defined above.
- Significantly more PEG 3350 patients (52%) were successfully treated compared to placebo (11%, P<0.001).
- PEG 3350 was significantly superior (P<0.001) to placebo for:
- Number of bowel movements per week
- Satisfactory bowel movements per week
- Complete spontaneous bowel movements
- While the individual GI adverse events did not differ significantly than with placebo, when combined these GI events (diarrhea, flatulence, loose stools, and nausea) occurred significantly more often with PEG than with placebo (40% vs 25%, P<0.015).
- No clinically significant changes in laboratory test results were reported.
- A 2011 Cochrane review identified and reviewed all randomized controlled trials comparing the use of lactulose and polyethylene glycol in the management of fecal impaction and chronic constipation (Rome III criteria) in adults and children. Both monotherapy and crossover studies were reviewed.
- The findings of this meta-analysis indicate that polyethylene glycol is better than lactulose in outcomes of stool frequency per week, form of stool, relief of abdominal pain, and the need for additional products.
References: 1. DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-450. 2. Cleveland MV, Flavin DP, Ruben RA, Epstein RM, Clark GE. New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. South Med J. 2001;94(5):478-481. 3. Ramkumar D, Rao S. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005;100(4):936-971. 4. DiPalma JA, Cleveland MB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007;100(11):1085-1090. 5. DiPalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102(7):1436-1441. 6. Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus polyethylene glycol for chronic constipation: review. Cochrane Database Syst Rev. 2010;7:1-38.
Start your patients on MiraLAX® first
MiraLAX® is available in a variety of dosing sizes, including travel-size packets
MiraLAX® is easily accessible at national drug store chains, supermarkets, mass merchandisers, and club stores.
Mix-In Pax Single-Serve Packets
Available in 10- and 20-count packages
Remind patients that MiraLAX® is easy to take
The powder dissolves easily in water or any beverage.
- No taste or grit
- Gluten and sugar free