POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES

1 INDICATIONS AND USAGE PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 ) PEG-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

2 DOSAGE AND ADMINISTRATION Preparation and Administration (2.1): Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution. Reconstitute PEG-3350 and electrolytes for oral solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of PEG-3350 and electrolytes for oral solution. (2.1) Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy. Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. Adult Dosing Regimen (2.2): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regimen for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2) 2.1 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution [see Warnings and Precautions (5.1)]. Reconstitute PEG-3350 and electrolytes for oral solutionwith water prior to ingestion, do not take undissolved PEG-3350 and electrolytes for oral solution [see Dosage and Administration (2.2)]. Do not take oral medications within 1 hour before the start of or during administration of PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.2)]. Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.3)]. Consume only clear liquids, avoid red and purple liquids. Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue PEG-3350 and electrolytes for oral solution until the symptoms abate. 2.2 Dosage Regimen Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regiment for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy. Instruct patients to take PEG-3350 and electrolytes for oral solution in conjunction with clear liquids as follows: This preparation can be used with or without the lemon flavor pack. The pharmacist will add the lemon flavor pack prior to dispensing (see packet instructions) 4 Liter Jug Fill the supplied container containing the PEG-3350 and electrolytes for oral solution powder with lukewarm drinking water to the 4-liter fill line Do not add any other ingredients, flavors, etc After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour. After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion. Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted PEG-3350 and electrolytes for oral solution solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 ) Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 4 , 5.8 ) PEG-3350 and electrolytes for oral solution is contraindicated in the following conditions: Gastrointestinal (GI) obstruction ( 5.6 ) Bowel perforation ( 5.6 ) Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 5.8 )

Not available.

6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating abdominal cramps, vomiting and anal irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions ( 5.5 )] Patients with significant gastrointestinal disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of PEG-3350 and electrolytes for oral solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )]. Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications (4), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].