DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Miralax (Polyethylene Glycol 3350 Powder) - Warnings and Precautions

 
 



WARNINGS

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating MiraLax therapy.

PRECAUTIONS

General:    Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel habits.

MiraLax should be administered after being dissolved in approximately 8 ounces of water, juice, soda, coffee, or tea.

Information for Patients:    MiraLax softens the stool and increases the frequency of bowel movements by retaining water in the stool. It should always be taken by mouth after being dissolved in 8 ounces of water, juice, soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur, consult your physician.

Two to 4 days may be required to produce a bowel movement. This product should be used for 2 weeks or less or as directed by a physician. Prolonged, frequent or excessive use of MiraLax may result in electrolyte imbalance and dependence on laxatives.

Laboratory Tests:    No clinically significant effects on laboratory tests have been demonstrated.

Drug Interactions:    No specific drug interactions have been demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term carcinogenicity studies, genetic toxicity studies and reproductive toxicity studies in animals have not been performed with MiraLax.

Pregnancy:    Category C. Animal reproductive studies have not been performed with MiraLax. It is also not known whether MiraLax can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. MiraLax should only be administered to a pregnant woman if clearly needed.

Pediatric Use:    Safety and effectiveness in pediatric patients has not been established.

Geriatric Use:    There is no evidence for special considerations when MiraLax is administered to elderly patients.

In geriatric nursing home patients a higher incidence of diarrhea occurred at the recommended 17 gram dose. If diarrhea occurs MiraLax should be discontinued.

Page last updated: 2006-02-18

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014