ncrease the risk of mucosal ulceration or ischemic colitis. avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking nulytely.

e, and bun) and treat accordingly. fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. fluid and electrolyte abnormalities should be corrected before treatment with nulytely. in addition, use caution when prescribing nulytely for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see drug interactions ( 7.1 )] 5.2 cardiac arrhythmias there have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. use caution when prescribing nulytely for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged qt, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). pre-dose and post-colonoscopy ecgs should be considered in patients at increased risk of serious cardiac arrhythmias. 5.3 seizures there have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. the seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. the neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. use caution when prescribing nulytely for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia. 5.4 renal impairment use caution when prescribing nulytely for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). advise these patients of the importance of adequate hydration, and consider performing baseline and postcolonoscopy laboratory tests (electrolytes, creatinine, and bun) in these patients. 5.5 colonic mucosal ulcerations and ischemic colitis administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. concurrent use of stimulant laxatives and nulytely may increase this risk. the potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (ibd). 5.6 use in patients with significant gastrointestinal disease if gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering nulytely. if a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. if gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of nulytely. use with caution in patients with severe active ulcerative colitis. 5.7 aspiration use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. such patients should be observed during administration of nulytely, especially if it is administered via nasogastric tube. use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. such patients should be observed during administration of nulytely, especially if it is administered via nasogastric tube. do not combine nulytely with starch-based thickeners [see dosage and administration (2.1)]. polyethylene glycol (peg), a component of nulytely, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. when a peg-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported. 5.8 not for direct ingestion the contents of each jug must be diluted with water to a final volume of 4 liters (4 l) and ingestion of additional water is important to patient tolerance. direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

iew nulytely, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see dosage and administration ( 2.2 ), warnings and precautions ( 5.8 )] . do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see warnings and precautions ( 5.7 )] . the 4-liter reconstituted nulytely solution contains: 420 grams of polyethylene glycol (peg) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, 1.4 grams of potassium chloride and 2 grams of flavor ingredients. 2.2 administration instructions prior to dosage on the day prior to the colonoscopy, instruct patients to: a) take only clear liquids, but avoid red and purple liquids. patients may consume a light breakfast. b) early in the evening prior to colonoscopy , fill the supplied container containing the nulytely powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. the solution is clear and colorless when reconstituted to a final volume of 4 liters. c) after capping the container, shake vigorously several times to ensure that the ingredients are dissolved. when reconstituted use within 48 hours. 2.3 dosage the following is the recommended dose of reconstituted nulytely solution for adults and pediatric patients ≥ 6 months. instruct patients they may consume water or 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. adults: instruct patients to drink a total of up to 4 liters at a rate of 240 ml (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. rapid drinking of each portion is preferred to drinking small amounts continuously. for ngt, rate is 20-30 ml per minute (1.2 – 1.8 liters per hour). pediatric patients ≥ 6 months: pediatric patients should drink 25 ml/kg/hour until the stool is watery, clear, and free of solid matter. if pediatric patients are unable to drink the reconstituted nulytely solution, the solution may be given by nasogastric (ngt). ngt administration is at the rate of 25 ml/kg/hour. the first bowel movements should occur approximately one hour after the start of nulytely administration. continue drinking until the watery stool is clear and free of solid matter.

lness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of nulytely. abdominal cramps, vomiting and anal irritation occur less frequently. these adverse reactions are transient and usually subside rapidly. isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. published literature contains isolated reports of serious adverse reactions following the administration of peg-electrolyte solution 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” infiltrates on chest x-ray after vomiting and aspirating peg. most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) to report suspected adverse reactions, contact braintree laboratories, inc. at 1-800-874-6756 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

ncrease the risk of mucosal ulceration or ischemic colitis. avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking nulytely.

ported in one child and hypokalemia has been reported in 3 children. 8.5 geriatric use clinical studies of nulytely did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

1 )] . that oral medication administered within one hour of the start of administration of nulytely solution may be flushed from the gi tract and the medication may not be absorbed completely. manufactured by braintree laboratories, inc., braintree, ma 02185 marketed by braintree, a part of sebela pharmaceuticals®