Polyethylene glycol

Pharmacology:

Polyethylene Glycol 3350, NF Powder for Oral Solution is an osmotic agent which causes water to be retained with the stool.

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

For the treatment of occasional constipation. This product should be used for 2 weeks or less or as directed by a physician.

Polyethylene Glycol 3350, NF Powder for Oral Solution is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to Polyethylene Glycol.

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.

Polyethylene Glycol 3350, NF Powder for Oral Solution should be administered after being dissolved in approximately 4-8 ounces of water, juice, soda, coffee, or tea.

Information for Patients:

Polyethylene Glycol 3350, NF Powder for Oral Solution 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 4-8 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 Polyethylene Glycol 3350, NF Powder for Oral Solution 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 Polyethylene Glycol 3350, NF Powder for Oral Solution.

Pregnancy:

Animal reproductive studies have not been performed with Polyethylene Glycol 3350, NF Powder for Oral Solution. It is also not known whether Polyethylene Glycol 3350, NF Powder for Oral Solution can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Polyethylene Glycol 3350, NF Powder for Oral Solution 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 Polyethylene Glycol 3350, NF Powder for Oral Solution 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, Polyethylene Glycol 3350, NF Powder for Oral Solution should be discontinued.

There have been no reports of accidental overdosage. In the event of overdosage, diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered. The oral LD50 is >50 gm/Kg in mice, rats and rabbits.

The usual dose is 17 grams (about 1 heaping tablespoon or one sachet) of powder per day (or as directed by physician) in 4-8 ounces of water, juice, soda, coffee, or tea.

Each bottle of Polyethylene Glycol 3350, NF Powder for Oral Solution is supplied with a dosing cup marked to contain 17 grams of laxative powder when filled to the indicated line.

Each box of Polyethylene Glycol 3350, NF Powder for Oral Solution contains 14 sachets, each sachet containing 17 grams of laxative powder.

Two to 4 days (48 to 96 hours) may be required to produce a bowel movement.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

To report a suspected adverse reaction to this product, please call 1-866-634-9120.

Distributed By

Perrigo®

Minneapolis, MN 55427

7A600 RC J1 Rev 02-14 A

Consult your pharmacist.

How to use Polyethylene Glycol 8000 Powder

Consult your pharmacist.