GaviLyte G

Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of GaviLyte-G. 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 GaviLyte-G, 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 GaviLyte-G.

In addition, use caution when prescribing GaviLyte-G 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)]

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 GaviLyte-G 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.

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 GaviLyte-G 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.

Renal Impairment

Use caution when prescribing GaviLyte-G 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 post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

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 GaviLyte-G 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).

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 GaviLyte-G. 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 GaviLyte-G.

Use with caution in patients with severe active ulcerative colitis.

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 PEG-3350 and electrolytes for oral solution, especially if it administered via nasogastric tube.

Not for Direct Ingestion

The contents of each jug must be diluted with water to a final volume of 4 liters (4L) 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 GaviLyte-G 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 GaviLyte-G may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Stimulant Laxatives

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

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with GaviLyte-G. It is also not known whether GaviLyte-G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-G should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GaviLyte-G is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of GaviLyte-G in pediatric patients have not been established.

Geriatric Use

Clinical studies of GaviLyte-G 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.

For oral solution: Each 4 liter (4L) GaviLyte-G jug contains a white powder for reconstitution. GaviLyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.

Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.

Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:

Sodium Bicarbonate, USP

The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na+ Cl-

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

In powdered form, for oral administration as a solution following reconstitution. GaviLyte-G is available in a disposable jug in powdered form containing:

Disposable Jug:  polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Storage:

Store in sealed container at 59º to 86°F (15ºC to 30°C).  When reconstituted, keep solution refrigerated. Use within 48 hours, Discard unused portion.

Keep out of reach of children.

GaviLyte-G     NDC 43386-090-19

• If you have an allergy to polyethylene glycol or any other part of GaviLyte-G (polyethylene glycol-electrolyte solution).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bowel block, enlarged colon, hole in the GI (gastrointestinal) tract, or slow-moving GI (gastrointestinal) tract.
• If you have electrolyte (like sodium, potassium, phosphate) problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take GaviLyte-G with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

• Store powder at room temperature.
• After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long this medicine may be used after mixing.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about GaviLyte-G, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about GaviLyte-G. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using GaviLyte-G.

Review Date: October 4, 2017

Applies to polyethylene glycol 3350 with electrolytes: oral kit, oral powder for reconstitution

General

The most common adverse events were abdominal distension, anal discomfort, thirst, nausea, and abdominal pain. Since diarrhea is considered part of the efficacy of this product, it was not defined as an adverse reaction.[Ref]

Gastrointestinal

Very common (10% or more): Abdominal distension (59.8%), anal discomfort (52%), nausea (47.3%), abdominal pain (39.1%), vomiting (12.8%)
Common (1% to 10%): Upper abdominal pain, dyspepsia
Frequency not reported: Upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, borborygmi, flatulence[Ref]

Metabolic

Very common (10% or more): Hunger (70.8%)
Common (1% to 10%): Hypokalemia, hyperphosphatemia
Frequency not reported: Electrolyte disturbances, hyperkalemia[Ref]

Other

Very common (10% or more): Rigors (33.7%), malaise (26.6%)
Frequency not reported: Peripheral edema[Ref]

Nervous system

Very common (10% or more): Dizziness (18.1%)
Common (1% to 10%): Headache[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (34.9%)[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction
Postmarketing reports: Hypersensitivity reactions (including anaphylaxis, rash, angioedema, urticaria, lip and facial swelling, dyspnea, chest tightness, throat tightness)[Ref]

Cardiovascular

Frequency not reported: Asystole[Ref]

Dermatologic

Frequency not reported: Urticaria, dermatitis[Ref]

Respiratory

Frequency not reported: Rhinorrhea, acute pulmonary edema, acute pulmonary edema after aspirating the PEG-based preparation[Ref]

Some side effects of GaviLyte-G may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.