GoLYTELY (Page 3 of 3)
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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.
12.2 Pharmacodynamics
GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3 Pharmacokinetics
The pharmacokinetics of PEG3350 following administration of GoLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.
16 HOW SUPPLIED/STORAGE AND HANDLING
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 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 4 Liter Disposable Jug NDC 52268-100-01
Storage
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 ( 2.1)] .
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct Patients:
- To reconstitute GoLYTELY with water prior to ingestion.
- Not to take other laxatives while they are taking GoLYTELY.
- Not to take oral medications within 1 hour before the start or during the administration of GoLYTELY.
- To take only clear liquids but avoid red and purple liquids.
- To 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.
- To follow the directions in the Instructions for Use on how to prepare and administer the product.
- If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
- To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4)] .
- To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions ( 5.8)] .
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
| Medication Guide 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:
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| 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:
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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 over-the-counter 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:
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| How should I take GoLYTELY? You must read, understand, and follow these instructions to take GoLYTELY the right way.
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| What are the possible side effects of GoLYTELY? GoLYTELY can cause serious side effects, including:
The most common side effects of GoLYTELY include: • nausea • stomach (abdominal) cramps • anal irritation • stomach (abdominal) fullness • vomiting • esophageal bleeding • bloating • chest x-ray that shows water in the lungs (infiltrate) after vomiting or inhaling food or liquid (aspirate). 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 1-800-FDA-1088. |
| How should I store GoLYTELY? • Store GoLYTELY in a sealed container at room temperature, between 59ºF to 86°F (15ºC to 30°C). • Store mixed (reconstituted) solution of GoLYTELY at 36° to 46°F (2°C to 8°C). Do not freeze. • Use mixed (reconstituted) solution of GoLYTELY within 48 hours. • After 48 hours, throw away (discard) any mixed (reconstituted) solution of GoLYTELY that is not used. 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. 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 For more information go to www.braintreelabs.com or call 1-800-874-6756. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2021
Principal Display Panel
FILL TO THE TOP OF THE LINE ON BOTTLE
NDC 52268-100-01
TO PHARMACIST AND PATIENT: 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 PEG-3350 59 g/L, sodium sulfate 5.69 g/L, sodium bicarbonate 1.69 g/L, sodium chloride 1.47 g/L, and potassium chloride 0.743 g/L.
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.
RX only
Manufactured by Braintree Laboratories, Inc., Braintree, MA 02185
Marketed by Braintree, A part of Sebela Pharmaceuticals®
FILL TO THE TOP OF THE LINE ON BOTTLE
NDC 52268-101-01
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient.
Pineapple Flavor
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 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavor ingredients 3.0 g.
RX only M 9/13
Braintree
Laboratories, Inc
Braintree, MA 02185
NDC 52268-700-01
Rx only
GoLYTELY®
PEG-3350 AND ELECTROLYTES
FOR ORAL SOLUTION
1 Gallon (3.785 Liters)
Instructions
A GoLYTELY® solution is made up by dissolving the contents of this packet in one gallon of tap
water according to the following procedure:
Obtain a food-grade clear container with a volume of at least one gallon.
After cutting open the packet, pour the entire contents into the container.
Add lukewarm drinking water to bring the volume of the solution to one gallon.
Do not add any other ingredients, flavors, etc.
Shake and/or mix thoroughly to ensure that the ingredients are dissolved.
The solution is more palatable if chilled in the refrigerator before drinking. Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portion.
For best results, no solid food should be consumed for the 3 to 4 hour period before drinking the solution; but in no case should solid food be eaten within two hours of taking GoLYTELY.
Drink one 8 oz. glassful of the solution rapidly every 10 minutes. A loose watery bowel movement should result in approximately one hour. Continue drinking until the rectal effluent is clear or the entire contents (1 gallon) have been consumed or as directed by your physician.
Usual dosage: 1 gallon (3.785 liters).
This package contains:
Polyethylene glycol 3350…..227.1 grams
Sodium sulfate, anhydrous….21.5 grams
Sodium bicarbonate………….6.36 grams
Sodium chloride………………5.53 grams
Potassium chloride…………..2.82 grams
APPROXIMATE NET WEIGHT: 263 grams Distributed by Braintree Laboratories, Inc., Braintree, MA 02185
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| Labeler — Braintree Laboratories, Inc. (107904591) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Braintree Laboratories, Inc. | 617357954 | manufacture (52268-100), manufacture (52268-101), manufacture (52268-700) | |
Revised: 05/2021 Braintree Laboratories, Inc.
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