Polyethylene Glycol 3350
FDA Label NDC 0722-6921

A white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350

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.

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.

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 is contraindicated in patients with known or suspected bowel

obstruction and patients known to be allergic to polyethylene glycol.

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.

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 to 8 ounces of water, juice, soda, coffee or tea.

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 to 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 your physician. Prolonged, frequent or excessive use of

Polyethylene Glycol 3350 NF may result in electrolyte imbalance and dependence on laxatives.

No clinically significant effects on laboratory tests have been demonstrated.

No specific drug interactions have been demonstrated.

Long term carcinogenicity studies,

genetic toxicity studies or reproductive toxicity studies in animals have not been performed

with Polyethylene Glycol 3350 NF.

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.

Safety and effectiveness in pediatric patients has not been established.

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 g dose. If diarrhea occurs

Polyethylene Glycol 3350 NF should be discontinued.

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.

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) of powder per day (or as directed

by physician) in 4 to 8 ounces of water, juice, soda, coffee, or tea. Each bottle of

Polyethylene Glycol 3350 NF is supplied with a dosing cup 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.

In powdered form, for oral administration after dissolution in water, juice, soda, coffee, or

tea. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder for Oral Solution) is

available in two package sizes: a 500 cc container of 255 grams of laxative powder and a

950 cc container of 527 grams of laxative powder.

NDC 0722-6920-01 Polyethylene Glycol 3350 NF 255g

NDC 0722-6921-01 Polyethylene Glycol 3350 NF 527g

The dosing cup 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).

Rx only

Keep this and all medications out of the reach of children.

STORAGE

Store at 20°- 25°C (68°- 77°F); excursions permitted to 15° - 30°C (59° - 86°F).

[See USP Controlled Room Temperature]

Manufactured by:

Nexgen Pharma, Inc.

Irvine, CA 92614

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

6920, 6921 Rev 11/08

PATIENT INFORMATION

Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 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 cup (or use one heaping tablespoon of powder), stir and

dissolve in a glass (4 to 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 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 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.