POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES

Paddock Laboratories, Inc.

Polyethylene Glycol 3350 and Electrolytes for Oral Solution

FULL PRESCRIBING INFORMATION: CONTENTS*

• POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES DESCRIPTION:
• CLINICAL PHARMACOLOGY:
• POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES INDICATIONS AND USAGE:
• POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS:
  • General:
  • INFORMATION FOR PATIENTS:
  • DRUG INTERACTIONS:
  • CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
  • PREGNANCY:
  • PEDIATRIC USE:
  • GERIATRIC USE:
• POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES ADVERSE REACTIONS:
• POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES DOSAGE AND ADMINISTRATION:
  • ORAL:
  • NASOGASTRIC TUBE:
  • PREPARATION OF SOLUTION
• HOW SUPPLIED:
• PRINCIPAL DISPLAY PANEL - 4 Liter Bottle Label

FULL PRESCRIBING INFORMATION

4 Liters

For Gastrointestinal Lavage

DESCRIPTION:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution is a colon lavage preparation provided as a white to off-white mixture of water soluble components for solution. In solution this preparation delivers the following, in grams per liter.

When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is an isosmotic solution, for oral administration, having a mildly salty taste. This preparation is administered orally or via nasogastric tube.

CLINICAL PHARMACOLOGY:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.

INDICATIONS AND USAGE:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

CONTRAINDICATIONS:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution is contraindicated in patients known to be hypersensitive to any of the components. Polyethylene Glycol 3350 and Electrolytes for Oral Solution is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

WARNINGS:

No other additional ingredients (e.g., flavorings) should be added to the solution. Polyethylene Glycol 3350 and Electrolytes for Oral Solution should be used with caution in patients with severe ulcerative colitis.

PRECAUTIONS:

General:

Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of Polyethylene Glycol 3350 and Electrolytes for Oral Solution, especially if it is administered via nasogastric tube.

If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of Polyethylene Glycol 3350 and Electrolytes for Oral Solution.

INFORMATION FOR PATIENTS:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be ingested during the 3 to 4 hour period prior to the initiation of Polyethylene Glycol 3350 and Electrolytes for Oral Solution administration. In no case should solid foods be eaten within 2 hours of drinking Polyethylene Glycol 3350 and Electrolytes for Oral Solution.

The rate of administration is 240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately one hour after the start of Polyethylene Glycol 3350 and Electrolytes for Oral Solution administration.

Administration of Polyethylene Glycol 3350 and Electrolytes for Oral Solution should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3 to 4 liters (3 to 4 quarts), although more or less may be required in some patients. The unused portion should be discarded.

DRUG INTERACTIONS:

Oral medication administered within one hour of the start of administration of Polyethylene Glycol 3350 and Electrolytes for Oral Solution may be flushed from the gastrointestinal tract and not absorbed.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Studies to evaluate carcinogenic or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

PREGNANCY:

Category C.

Animal reproduction studies have not been conducted with Polyethylene Glycol 3350 and Electrolytes for Oral Solution, and it is not known whether Polyethylene Glycol 3350 and Electrolytes for Oral Solution can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Polyethylene Glycol 3350 and Electrolytes for Oral Solution should be given to a pregnant patient only if clearly needed.

PEDIATRIC USE:

Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE:

Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest x-ray after vomiting and aspirating PEG.

ADVERSE REACTIONS:

Nausea, abdominal fullness and bloating are the most frequent adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

DOSAGE AND ADMINISTRATION:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Polyethylene Glycol 3350 and Electrolytes for Oral Solution administration.

ORAL:

The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see INFORMATION FOR PATIENTS). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 to 4 liters.

NASOGASTRIC TUBE:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution is administered at a rate of 20 to 30 mL per minute (1.2 to 1.8 L/hour).

PREPARATION OF SOLUTION

Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)

HOW SUPPLIED:

Polyethylene Glycol 3350 and Electrolytes for Oral Solution is supplied in 4 liter bottles. Each 4 liter bottle contains polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution.

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

KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.

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

Pat. 4488922

Polyethylene Glycol 3350 and Electrolytes for Oral Solution

Instructions for Pharmacist:

Dispense bottle to the patient.

Instructions for Patient:

• Add tap water to the top of the FILL line marked 4 liters. Recap tightly and mix or shake well until the powder has completely dissolved. No additional ingredients should be added to the solution.
• Refrigerate the solution until ready to drink. Chilling improves the taste. Store no longer than 48 hours.
• For best results, solid food should not be eaten during the 3 to 4 hour period before you start drinking the solution. Never eat solid food within 2 hours of drinking the solution.
• Drink a glassful (8 oz.) of the solution every 10 minutes. It is best to drink the solution rapidly, rather than sipping slowly. Continue drinking a glassful every 10 minutes until your watery stool is clear and free of solid matter. This normally requires drinking 3 to 4 liters (3 to 4 quarts). The bottle should be empty (4 liters consumed) or the remaining solution should be at or below 1 liter (at least 3 liters consumed).

KEEP RECONSTITUTED SOLUTION REFRIGERATED.
USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.

NDC 0574-0428-04

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

PRINCIPAL DISPLAY PANEL - 4 Liter Bottle Label

FILL TO THE TOP OF THE LINE ON BOTTLE

PEEL
HERE

NDC 0574-0428-04

POLYETHYLENE GLYCOL 3350 (240 g)
and ELECTROLYTES for ORAL SOLUTION

Rx ONLY

NOTE TO PHARMACIST: Dispense bottle to patient. Package insert enclosed.
Remove before dispensing.

4 Liters

This bottle contains the following ingredients:

Polyethylene glycol 3350    240.00 grams
Sodium chloride    5.84 grams
Potassium chloride    2.98 grams
Sodium bicarbonate    6.72 grams
Sodium sulfate (anhydrous)    22.72 grams

When dissolved in sufficient water to make 4 liters, the final solution contains125 mEq/L
sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate,35 mEq/L chloride
and 18 mEq/L polyethylene glycol 3350.

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

KEEP RECONSTITUTED SOLUTION REFRIGERATED.
USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.

APPROXIMATE NET WEIGHT 278 GRAMS

Paddock
Laboratories, Inc.