HCP Interstitial

MiraLAX® is an osmotic laxative with dual benefits– It relieves constipation and softens stool.

  • Clinically proven effective [3-11]
  • MiraLAX is the #1 GI recommended laxative [2]
  • No evidence for physical dependence
  • Well tolerated [3-11]

In multiple clinical trials, MiraLAX has been proven to: [3-11]

  • Increase water content and volume of stool
  • Soften stool to ease passage
  • Result in a bowel movement within 24–72 hours of an oral dose
  • Significantly increase the frequency of bowel movements vs placebo (P<0.001)

PEG laxatives like MiraLAX are now recommended as a first-line constipation therapy by the AGA[1]

Let your patients experience the MiraLAX® Difference

As MiraLAX laxative gently draws water into the colon, the body responds naturally for a normal bowel movement. It results in:

  • Both stool softening and laxative effects [3-11]
  • Complete, comfortable, and predictable relief [3-11]
  • No harsh side effects [3-11]
    • No sudden urgency, no gas, no bloating, no cramping [5]

MiraLAX provides gentle, predictable relief for a broad range of patients:

  • Proven effective in women and men, 17 and older[5]
  • Proven effective in elderly patients [7]
  • Proven effective in patients taking constipating medications [12]
  • No known drug-drug interactions [5]

Polyethylene Glycol 3350, the active ingredient in MiraLAX,
is one of only 2 laxatives with a Grade A recommendation
from the American College of Gastroenterology [13]

MiraLAX® Drug Facts

Purpose

Osmotic Laxative

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition
  • you get diarrhea
  • you need to use a laxative for longer than 1 week

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions
  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • adults and children 17 years of age and older:
    • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature), then drink
    • use once a day
    • use no more than 7 days
  • children 16 years of age or under: ask a doctor
Other information
  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive ingredients

none

Questions or comments?

1-800-MiraLAX (1-800-647-2529) or www.MiraLAX.com

Summary of Key MiraLAX® Clinical Studies and Analyses

Including Safety and Efficacy Data Points

12-month open-label, single-arm, multicenter study

  • Patients meeting modified Rome functional constipation criteria evaluated daily use of 17 gm PEG 3350 (n= 311). A total of 184 patients (59.2%) completed 12 months of therapy, and only 4.0% discontinued due to lack of efficacy
  • At office visits at 2, 4, 6, 9, and 12 months, 80%-88% of patients reported complete or considerable relief of constipation, and 85%-92% no longer met the Rome functional constipation criteria
  • The frequency of individual GI adverse effects was: diarrhea 10.6%, flatulence 7.4%, nausea 5.5%, and abdominal pain 5.2%
  • No clinically significant changes in laboratory test results including hematology or blood chemistry (electrolytes) were reported

    DiPalma JA, Cleveland M VB, McGowan J, Herrera JL. An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Aliment Pharmacol Ther. 2006;25:703-708.[6]

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28-day randomized, double-blind, placebo-controlled trial in patients with medication-induced constipation

  • Patients taking medications causing a >3% incidence of constipation were randomized to treatment with 17 gm PEG 3350 daily or placebo for 28 days (n =100)
  • The primary efficacy variable was based on relief the presence of no more than one of the following: straining, lumpy/hard stool, incomplete evacuation, anorectal obstruction, or manual movements in >25% of bowel movements; or <3 bowel movements per week over the last 7 days of treatment
  • PEG 3350 was significantly superior (P<0.001) to placebo for:
    • increased bowel movement frequency
    • improved stool consistency
    • less straining
    • patient and investigator rated effectiveness and acceptability
  • The frequency of individual GI adverse effects was similar to placebo, and no clinically significant changes in laboratory test results were reported

    DiPalma JA, Cleveland MVB, 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.[12]

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6-month randomized, double-blind, placebo-controlled, multicenter trial

  • 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, and/or sensation of incomplete evacuation in >25% of defecations for a 3-month period were randomized to treatment with 17 gm PEG 3350 daily or placebo (n= 304)
  • The primary efficacy variable was based on relief of the modified Rome criteria defined above with no rescue laxative use. 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:
    • the number of bowel movements per week
    • satisfactory bowel movements per week
    • complete spontaneous bowel movements
  • The frequency of individual GI adverse effects did not differ significantly from placebo
  • The combined frequency of diarrhea, flatulence, loose stools, and nausea occurred more often with PEG 3350 than with placebo (40% vs 25%, P<0.015)
  • No clinically significant changes in laboratory test results were reported

    DiPalma JA, Cleveland MVB, 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;1436-1441.[7]

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Daily therapy with MiraLAX for 14 days resulted in a significant improvement in bowel movement frequency

  • 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 and were watched for any changes in how often they had bowel movements
  • After 14 days, patients given MiraLAX had significantly (P=.0001) more bowel movements than those on placebo, and they had no serious side effects

    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.[4}

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In a 2-week trial, MiraLAX was significantly more effective than placebo for the treatment of constipation

  • 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 changes to the bowel movement itself
  • After 2 weeks, patients who took MiraLAX had significantly (P<.001) more bowel movements than those who were given a placebo, and also had less cramping and gas

    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.[9}

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MiraLAX increased frequency and improved the quality of bowel movements, with no severe side effects

  • Evaluated the safety and effectiveness of MiraLAX laxative in 50 people with constipation
  • Study participants were either ambulatory outpatients or living in long-term care facilities
  • Patients received a placebo or a high (34 grams) or low (17 grams) dose of MiraLAX (later reduced to 12 and 6 grams, respectively, in long-term care patients)
  • All patients given MiraLAX 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 yielded better bowel movements more often versus lower doses, and people given either dose of MiraLAX had better outcomes than those on placebo

    DiPalma JA, MacRae DH, Reichelderfer M, et al. Braintree polyethylene glycol (PEG) laxative for ambulatory and long-term care facility constipation patients. Online J Dig Health. 1999;1(2).1-10.[10}

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In an analysis of numerous clinical trials, polyethylene glycol received a Grade A recommendation

  • Clinical trials conducted between 1966 and 2003 to evaluate the safety and efficacy of laxatives were studied and compared to make guideline recommendations for their use
  • Polyethylene glycol and tegaserod received Level 1, Grade A ratings
    • Level 1 – consistent results from well-designed, well-conducted studies
    • Grade A – good evidence in support of the use of a modality in the treatment of constipation
  • Considerable evidence also supported the use of psyllium and lactulose

    Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005;100(4):936-971.[14}

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Polyethylene glycol outperformed lactulose in outcomes of stool frequency per week, form of stool, and relief of abdominal pain

  • The authors of this analysis 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). Both monotherapy and crossover studies were reviewed
  • The authors concluded 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

    Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus polyethylene glycol for chronic constipation. The Cochrane Library. 2010; Issue 7:1-38.[15}

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The patients studied in MiraLAX clinical studies were selected based on modified Rome III criteria. There is no clinical differentiation between the symptoms of chronic and occasional constipation. Occasional constipation is the term used in the over-the-counter (OTC) setting as a condition that can be self-diagnosed by consumers. Use of an OTC laxative for periods longer than 7 days may mask an underlying condition that requires medical diagnosis and treatment.

More than one reason to recommend MiraLAX®

MiraLAX MiraLAX

3 sizes 7, 14, and
30 dose bottles

Convenient, pre-measured single dose packets are available in a 10-count carton – handy for taking MiraLAX any time, anywhere

  • Tell your patients to look for the pink cap. It is easy to find in the laxative aisle at national drugstore chains, supermarkets, mass merchandisers, and club stores

Recommend MiraLAX – the economical OTC choice

  • Available over the counter, making it a convenient option for patients
  • Helpful for patients trying to manage their Medicare Part D medication costs
    • An OTC product
    • Helps patients save Part D dollars for more costly prescription-only medications or medications without OTC alternatives