Nulytely

The following adverse reactions have been identified during post-approval use of NuLYTELY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nausea, abdominal fullness 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.

Read the entire FDA prescribing information for NuLytely (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution)

• CoLyte
• GaviLyte-C
• GaviLyte-G
• GaviLyte-H
• GaviLyte-N
• GoLytely

• Halflytely
• MoviPrep
• OsmoPrep
• Prepopik
• TriLyte

© NuLytely Patient Information is supplied by Cerner Multum, Inc. and NuLytely Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

NuLYTELY is part of the drug classes:

• Electrolyte solutions

• Salt solutions

• POTASSIUM

• Sodium

The polyethylene glycol (PEG), sodium and potassium salts solution is used to cleanse the colon (bowel) before a medical test (eg, colonoscopy).

The PEG, sodium and potassium salts solution is a laxative. It works by causing you to have diarrhea to clean your colon. Cleaning your colon will help your doctor see the inside of your colon more clearly during colonoscopy.

This medicine is available only with your doctor's prescription.

• It is used to clean out the GI (gastrointestinal) tract.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Belly pain.
• Swelling of belly.
• Very upset stomach or throwing up.
• Very bad headache.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• Bleeding from rectum or rectal pain.
• This medicine may cause you to be dehydrated or have electrolyte problems. Rarely, this may be very bad or deadly. Tell your doctor right away if you get very dizzy, pass out, feel very tired or weak, or have a fast heartbeat, a heartbeat that does not feel normal, or seizures. Tell your doctor right away if you have headache, mood changes, confusion, muscle pain or weakness, more thirst, not hungry, dry mouth, dry eyes, very bad upset stomach or throwing up, if you are unable to pass urine, or if you have a change in the amount of urine produced.

Dosage Overview

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)]. 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, and 1.4 grams of potassium chloride. NuLYTELY may be used with or without one of the supplied flavor packs.

Administration Instructions Prior to Dosage

On the day prior to the colonoscopy, instruct patients to:

1. Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.
2. If adding a NuLYTELY flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The NuLYTELY flavor packs are for use only in combination with the contents of the accompanying 4 liter container.
3. Early in the evening prior to colonoscopy, fill the supplied container containing the NuLYTELY powder (and if applicable, a flavor 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.
4. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

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.

5.1 Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of NuLYTELY. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking NuLYTELY, consider performing post-colonoscopy lab tests (electrolytes, creatinine, 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.

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.

Drugs that May Lead to Fluid and Electrolyte Abnormalities

Use caution when prescribing NuLYTELY for patients 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.4)] in patients taking these concomitant medications.

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of NuLYTELY may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Stimulant Laxatives

Concurrent use of stimulant laxatives and NuLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking NuLYTELY.

Applies to polyethylene glycol 3350 with electrolytes: oral powder for solution

Other dosage forms:

• oral powder for solution, oral powder for suspension

Along with its needed effects, polyethylene glycol 3350 with electrolytes (the active ingredient contained in NuLYTELY) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking polyethylene glycol 3350 with electrolytes:

• Full or bloated feeling
• pain in the upper stomach
• pressure in the stomach
• stomach pain
• swelling of abdominal or stomach area
• vomiting

• Coma
• confusion
• convulsions
• decreased urine output
• dizziness
• dry mouth
• fast or irregular heartbeat
• headache
• increased thirst
• loss of appetite
• muscle pain or cramps
• numbness or tingling in the hands, feet, fingertips, lips, or mouth
• shortness of breath
• swelling of the face, ankles, or hands
• unusual tiredness or weakness

Some side effects of polyethylene glycol 3350 with electrolytes may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, or pain around the anus
• difficulty with sleeping
• feeling unusually cold
• general feeling of discomfort or illness
• hunger
• nausea
• shivering
• thirst

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort or upset