Poly-Prep

Name: Poly-Prep

Purpose

Stimulant laxative

Uses

-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use if you cannot swallow without chewing

Other information

-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)
-use by expiration date on package
-protect from excessive humidity

Poly-Prep - Clinical Pharmacology

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.

Overdosage

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.

Poly-Prep Dosage and Administration

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.

Indications

Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

Carcinogenesis, mutagenesis, and impairment of fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

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