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What is GoLytely adn how is it used?
GoLytely is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLytely cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if GoLytely is safe and effective in children.
What are the possible side effects of GoLytely?
GoLytely can cause serious side effects, including:
The most common side effects of GoLytely include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of GoLytely. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
For oral solution: Each 1 gallon GoLYTELY packet contains a white powder for reconstitution. GoLYTELY 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 1 gallon packet contains: polyethylene glycol 3350 227.1g, sodium sulfate (anhydrous) 21.5 g, sodium bicarbonate 6.36 g, sodium chloride 5.53 g, potassium chloride 2.82 g. The solution is clear and colorless when reconstituted to a final volume of 1 gallon 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
GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting GoLYTELY. Begin the recommended dosage regiment for GoLYTELY early in the evening on the day before colonoscopy.
Instruct patients to take GoLYTELY in conjunction with clear liquids as follows:
For patients with a nasogastric tube, administer the reconstituted GoLYTELY solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).
For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
GoLYTELY (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder.
When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
GoLYTELY 4 Liter Disposable Jug NDC 52268-100-01
Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of GoLYTELY at 2° to 8°C (36° to 46°F). Do not freeze [see DOSAGE AND ADMINISTRATION].
Manufactured by Braintree Laboratories, Inc. 270 Centre Street Holbrook, MA 02343. Marketed by Braintree, a Part of Sebela Pharmaceuticals. 60 Columbian Street West Braintree, MA 02185. Revised: Jun 2020
The following clinically significant adverse reactions are described elsewhere in the labeling:
The following adverse reactions associated with the use of GoLYTELY 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.
Use caution when prescribing GoLYTELY for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see WARNINGS AND PRECAUTIONS]. Consider additional patient evaluations as appropriate.
GoLYTELY can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of GoLYTELY [see DOSAGE AND ADMINISTRATION].
Concurrent use of stimulant laxatives and GoLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [see WARNINGS AND PRECAUTIONS].
Included as part of the PRECAUTIONS section.
Advise patients to hydrate adequately before, during, and after the use of GoLYTELY. 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 GoLYTELY, 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. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY.
In addition, use caution when prescribing GoLYTELY 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].
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing GoLYTELY 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). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
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 GoLYTELY 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 [see DRUG INTERACTIONS].
Use caution when prescribing GoLYTELY 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) [see DRUG INTERACTIONS]. 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 [see Use Is Specific Populations].
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 GoLYTELY may increase this risk [see DRUG INTERACTIONS]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GoLYTELY [see CONTRAINDICATIONS]. Use with caution in patients with severe active ulcerative colitis.
Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.
GoLYTELY contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see ADVERSE REACTIONS]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct patients:
No Information provided
Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY should be given to a pregnant woman only if clearly needed.
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 GoLYTELY is administered to a nursing woman.
Safety and effectiveness of GoLYTELY in pediatric patients have not been established.
Clinical studies of GoLYTELY 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.
Use GoLYTELY with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see DRUG INTERACTIONS]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of GoLYTELY and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see WARNINGS AND PRECAUTIONS].
No Information provided
GoLYTELY is contraindicated in the following conditions:
The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.
GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
The pharmacokinetics of PEG 3350 following administration of GoLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.
GoLYTELY®
(Go-lite-ly)
(PEG-3350 and Electrolytes) for oral solution
Read this Medication Guide before you start taking GoLYTELY. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about GoLYTELY?
GoLYTELY and other osmotic bowel preparations can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.
These changes can cause:
Your chance of having fluid loss and changes in body salts with GoLYTELY is higher if you:
Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid(dehydration) while taking GoLYTELY:
See Section “What are the possible side effects of GoLYTELY” for more information about side effects.
What is GoLYTELY?
GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if GoLYTELY is safe and effective in children.
Who should not take GoLYTELY?
Do not take GoLYTELY if your healthcare provider has told you that you have:
What should I tell my healthcare provider before taking GoLYTELY?
Before you take GoLYTELY, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
GoLYTELY may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting GoLYTELY or after you start taking GoLYTELY. Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take GoLYTELY?
You must read, understand, and follow these instructions to take GoLYTELY the right way.
What are the possible side effects of GoLYTELY?
GoLYTELY can cause serious side effects, including:
The most common side effects of GoLYTELY include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of GoLYTELY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.
How should I store GoLYTELY?
Keep GoLYTELY and all medicines out of the reach of children.
General information about the safe and effective use of GoLYTELY.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GoLYTELY for a condition for which it was not prescribed. Do not give GoLYTELY to other people, even if they are going to have the same procedure you are. It may harm them.
This Medication Guide summarizes important information about GoLYTELY. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in GoLYTELY?
GoLYTELY comes in a 4-liter jug with GoLYTELY powder.
Active ingredients:
Powder for solution: polyethylene glycol 3350, sodium sulfate (anhydrous), sodium bicarbonate, sodium chloride, and potassium chloride.
FILL TO THE TOP OF THE LINE ON BOTTLE
Instructions for Use
GoLYTELY®
(Go-lite-ly) (PEG-3350 and Electrolytes) for oral solution
Read this Instructions for Use and the Medication Guide before you start taking GoLYTELY.
Important information
Prepare and take GoLYTELY
Keep GoLYTELY and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Xx/20xx
FILL TO THE TOP OF THE LINE ON BOTTLE
TO PHARMACIST AND PATIENT: NDC 52268-100-01
Mixing information is on base label.
Package insert may be removed before dispensing.
Dispense the enclosed Medication Guide to each patient.
GoLYTELY®
PEG-3350 and Electrolytes for Oral Solution
When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium, 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride, and 17.6 mmol/L polyethylene glycol 3350.
Each disposable jug contains, in powdered form: polyethylene glycol 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
