Polyethylene Glycol

Pronunciation

Generic Name: Polyethylene Glycol 3350
Dosage Form: powder, for oral solution

Polyethylene Glycol 3350, NF Powder for Oral Solution

Rx Only

Polyethylene Glycol Description

A white powder for reconstitution. Polyethylene Glycol 3350, NF Powder for Oral Solution is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups. Below 55°C, it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350, NF is an osmotic agent for the treatment of constipation.

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Polyethylene Glycol - Clinical Pharmacology

Pharmacology

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

Clinical Trials

In one study, patients with less than 3 bowel movements per week were randomized to Polyethylene Glycol 3350, NF, 17 grams, or placebo for 14 days. An increase in bowel movement frequency was observed for both treatment groups during the first week of treatment. Polyethylene Glycol 3350, NF was statistically superior to placebo during the second week of treatment.

In another study, patients with 3 bowel movements or less per week and/or less than 300 grams of stool per week were randomized to 2 dose levels of Polyethylene Glycol 3350, NF or placebo for 10 days each. Success was defined by an increase in both bowel movement frequency and daily stool weight. For both parameters, superiority of the 17 gram dose of Polyethylene Glycol 3350, NF over placebo was demonstrated.

Indications and Usage for Polyethylene Glycol

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

Contraindications

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

Warnings

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol 3350, NF 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.

Polyethylene Glycol 3350, NF 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 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 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.

Pregnancy

Category C

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

Adverse Reactions

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients.

Patients taking other medications containing Polyethylene Glycol have occasionally developed urticaria suggestive of an allergic reaction.

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.

Polyethylene Glycol Dosage and Administration

The usual dose is 17 grams (about 1 heaping tablespoonful) 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 is supplied with a dosing cap marked to contain 17 grams of laxative powder when filled to the indicated line.

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

How is Polyethylene Glycol Supplied

In powdered form, for oral administration after dissolution in water, juice, soda, coffee, or tea. Polyethylene Glycol 3350, NF Powder for Oral Solution is available in two package sizes: a 16 oz. container of 255 grams of laxative powder (NDC 642291-673-25) and a 24 oz. container of 527 grams of laxative powder (NDC 42291-673-57).

The dosing cap supplied with each bottle is marked with a measuring line and may be used to measure a single Polyethylene Glycol 3350, NF dose of 17 grams (about 1 heaping tablespoonful).

Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Distributed by:
Kremers Urban Pharmaceuticals Inc.
Princeton, NJ 08540, USA

CIA78340A Rev. 1E 07/13

DIRECTIONS

1.
NOTE: This product is supplied with a dosing cap marked to contain 17 grams of powder when filled to the indicated line.
2.
Daily dose is 17 grams per day or as directed by physician.
3.
Pour 17 grams (about 1 heaping tablespoonful) of powder into the dosing cap.
4.
Stir the powder in a cup (4 – 8 oz.) of water, juice, soda, coffee, or tea until completely dissolved.
5.
Drink the solution.
6.
Treatment for 2 to 4 days may be required to produce a bowel movement.

Keep this and other drugs out of reach of children.

Store at 20° – 25°C (68° – 77°F); excursions permitted between 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature].

Distributed by:
Kremers Urban Pharmaceuticals Inc.
Princeton, NJ 08540, USA

CIA78340A Rev. 1E 07/13

PATIENT INFORMATION

Polyethylene Glycol 3350, NF Powder for Oral Solution is a prescription only laxative which has been prescribed by your physician to treat constipation. This product should only be used by the person for whom it was prescribed.

How to take

The dose is 17 grams each day or as directed by physician. It should always be taken by mouth. Measure the dose using the dosing cap (or use one heaping tablespoonful of powder), stir and dissolve in a glass (4 - 8 oz.) of water, juice, soda, coffee, or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.

How will it work

Polyethylene Glycol 3350, NF softens the stool and increases the frequency of bowel movements by retaining water in the stool. Your first bowel movement will usually happen in two to four days, although results may vary for individual patients.

How long should I take it

Polyethylene Glycol 3350, NF achieves its best results when used between one and two weeks. You may discontinue taking the drug after you have had several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consult your physician. Polyethylene Glycol 3350, NF® is intended for up to a two week course of therapy. You should not use for a longer time unless directed by your physician.

Next Steps

After successfully completing the Polyethylene Glycol 3350, NF therapy (usually between one and two weeks), please discuss with your physician lifestyle changes which may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).

Who Should NOT take Polyethylene Glycol 3350, NF

Polyethylene Glycol 3350, NF should not be used by children. It should not be used by pregnant women unless prescribed by a physician.

Side Effects/Drug Reactions

Occasionally, Polyethylene Glycol 3350, NF may cause nausea, stomach fullness, cramping, diarrhea and/or gas. Do not take if you have symptoms such as nausea, vomiting, abdominal pain or distention, which may be due to bowel obstruction. On rare occasions, hives and skin rashes have been reported which are suggestive of an allergic reaction. If you get an allergic reaction, you should discontinue the medication and call your physician.

If you are allergic to Polyethylene Glycol, do not use this drug product.

Distributed by:
Kremers Urban Pharmaceuticals Inc.
Princeton, NJ 08540, USA

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

AvKARE

NDC
42291-673-25

Polyethylene Glycol 3350, NF
Powder for Oral Solution

This bottle contains
255 grams of Polyethylene Glycol 3350, NF powder

PRESCRIPTION LAXATIVE

Rx Only

CIA78337A
Rev. 1E 07/13

Polyethylene Glycol 3350  
Polyethylene Glycol 3350 powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-673
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 3350 1 g  in 1 g
Product Characteristics
Color WHITE (White to Off-White) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:42291-673-25 255 g in 1 BOTTLE
2 NDC:42291-673-57 527 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076652 07/05/2013
Labeler - AvKARE, Inc. (796560394)
Revised: 06/2014
 
AvKARE, Inc.
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