Polyethylene Glycol 3350

Paddock Laboratories, Inc.

Polyethylene Glycol 3350, NFPowder for Oral Solution

FULL PRESCRIBING INFORMATION: CONTENTS*

• POLYETHYLENE GLYCOL 3350 DESCRIPTION
• CLINICAL PHARMACOLOGY
  • Pharmacology:
• CLINICAL TRIALS
• POLYETHYLENE GLYCOL 3350 INDICATIONS AND USAGE
• POLYETHYLENE GLYCOL 3350 CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General:
  • Information for Patients:
  • Laboratory Tests:
  • Drug Interactions:
  • Carcinogenesis, Mutagenesis, Impairment of Fertility:
  • Pregnancy:
  • Pediatric Use:
  • Geriatric Use:
• POLYETHYLENE GLYCOL 3350 ADVERSE REACTIONS
• OVERDOSAGE
• POLYETHYLENE GLYCOL 3350 DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PATIENT INFORMATION
• PRINCIPAL DISPLAY PANEL - 527 gram Bottle Label

FULL PRESCRIBING INFORMATION

POLYETHYLENE GLYCOL 3350 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 Powder for Oral Solution is an osmotic agent for the treatment of constipation.

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.

CLINICAL TRIALS

In one study, patients with less than 3 bowel movements per week were randomized to Polyethylene Glycol 3350, NF Powder for Oral Solution, 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 Powder for Oral Solution 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 Powder for Oral Solution 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 Powder for Oral Solution over placebo was demonstrated.

POLYETHYLENE GLYCOL 3350 INDICATIONS AND USAGE

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 CONTRAINDICATIONS

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.

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 Powder for Oral Solution 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 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:

Category C.

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.

POLYETHYLENE GLYCOL 3350 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 3350 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.

HOW 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 three package sizes; a 16 oz. container of 255 grams of laxative powder (NDC 0574-0412-02), a 32 oz. container of 527 grams of laxative powder (NDC 0574-0412-05), and a box of 14 sachets, each sachet containing 17 grams of laxative powder (NDC 0574-0412-07).

The dosing cup with each bottle is marked with a measuring line and may be used to measure a single Polyethylene Glycol 3350, NF Powder for Oral Solution dose of 17 grams (about 1 heaping tablespoon).

STORAGE

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 1-800-328-5113.

Paddock Laboratories, Inc.
Minneapolis, MN 55427
(03-09)

Directions:

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

Paddock Laboratories, Inc.
Minneapolis, MN 55427
(03-09)

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 cup (or use one heaping tablespoonful of powder) or open and pour one sachet, 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 Powder for Oral Solution 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 Powder for Oral Solution 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 Powder for Oral Solution 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 Powder for Oral Solution 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 Powder for Oral Solution

Polyethylene Glycol 3350, NF Powder for Oral Solution 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 Powder for Oral Solution 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.

PRINCIPAL DISPLAY PANEL - 527 gram Bottle Label

NDC 0574-0412-05

POLYETHYLENE GLYCOL 3350, NF
POWDER FOR ORAL SOLUTION

Rx ONLY

Prescription Laxative

Keep this and other drugs out of the reach of children.

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

THIS BOTTLE CONTAINS 527 GRAMS OF
POLYETHYLENE GLYCOL 3350, NF POWDER

Paddock
Laboratories, Inc.