FIELD OF APPLICATIONDETAILS
Generic Name
Polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous
Active Ingredient
Polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous
US Brand Names
GOLYTELY, PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Drug Category
Osmotic Laxative / Iso-osmotic Bowel Evacuant
Route of Administration
Oral
FDA Approval Status
FDA approved (July 1984)
Approved

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Overview

The combination of polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous (widely recognized by brand names such as GoLYTELY and PEG 3350 and Electrolytes) is a prescription oral solution utilized primarily within Gastroenterology.

It is indicated for the complete cleansing of the colon in preparation for a colonoscopy or barium enema X-ray examination in adults and pediatric patients aged 6 months and older. As the original high-volume iso-osmotic bowel preparation, it delivers a high volume of liquid to physically flush the entire intestinal tract clean of stool, ensuring maximum visualization for gastroenterologists during diagnostic procedures.

Key Facts Summary

What Is POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS and How Does It Work?

This combination medication operates as an iso-osmotic laxative. It is precisely formulated to match the osmotic pressure of body fluids, preventing significant net absorption or loss of water and electrolytes across the intestinal wall.

Mechanism of Action

  • Osmotic Fluid Retention: The primary active ingredient, PEG 3350, is a large polymer that cannot be absorbed into the bloodstream. When dissolved in water, it holds the fluid inside the intestinal lumen by osmotic force, preventing the colon from absorbing the ingested water.
  • Mechanical Bowel Evacuation: Consuming a large volume of the solution rapidly expands the intestine. This stretching triggers powerful, continuous muscle contractions (peristalsis) that produce voluminous, watery diarrhea, physically sweeping the colon clean of all residual fecal matter.
  • Electrolyte Balance Preservation: Because massive diarrhea can dangerously drain the body’s mineral reserves, the addition of sodium sulfate, sodium chloride, potassium chloride, and sodium bicarbonate offsets electrolyte movement into or out of the body. This built-in balance minimizes shifts in serum sodium, potassium, and water.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS FDA Approval & Indications

The United States Food and Drug Administration officially approved this combination bowel preparation formulation on July 13, 1984.

Indications

Federal health regulators have authorized this medication for the following specific indication:

  • Colonoscopy and Radiographic Preparation: Indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination in adults and pediatric patients 6 months of age and older.

Before Taking POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS: Precautions & Safety

A thorough clinical evaluation is necessary prior to prescribing this high-volume bowel prep to ensure safe administration, particularly in patients with pre-existing organ dysfunction or swallowing difficulties.

Contraindications

  • Patients with known or suspected gastrointestinal obstruction (a physical blockage in the bowels) or ileus.
  • Patients with a bowel perforation (a hole in the stomach or intestinal wall).
  • Patients with toxic colitis or toxic megacolon (severe, life-threatening inflammation or dilation of the large intestine).
  • Patients with gastric retention (impaired stomach emptying).
  • Patients with a known hypersensitivity to polyethylene glycol or any component of the formulation.

Pregnancy & Breastfeeding

Animal reproduction studies have not been conducted with GoLYTELY. Because PEG 3350 is absorbed to a negligible degree, systemic exposure to the fetus is minimal. However, it should be administered to a pregnant woman only if clearly needed. Caution should be exercised when administered to a nursing mother.

Medical Conditions & Disclosures

Inform your doctor if you have a history of severe kidney impairment, congestive heart failure, cardiac arrhythmias, a history of seizures, or impaired swallowing/gag reflexes (which increases the risk of fluid aspiration into the lungs). Disclose all active medications, particularly blood pressure drugs (ACE inhibitors, ARBs), diuretics (water pills), and NSAIDs.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Dosage & Administration

GoLYTELY requires the consumption of a 4-liter solution. Modern clinical guidelines strongly favor a Split-Dose Regimen to achieve optimal colon cleanliness.

Reconstitution Process

  1. The pharmacy dispenses a 4-liter plastic jug containing the dry powder mixture.
  2. Add lukewarm tap water to the jug up to the 4-liter mark.
  3. Cap the container securely and shake vigorously until all powder is completely dissolved.
  4. Refrigerating the reconstituted solution between 2°C and 8°C (36°F to 46°F) prior to drinking significantly improves its palatability.

Standard Split-Dose Regimen (Adults)

  • Dose 1 (Evening Before Procedure): Drink 240 mL (8 ounces) of the solution every 10 minutes until exactly 2 liters (half of the jug) have been consumed. Rapid drinking of each 8-ounce glass is preferred over continuous sipping.
  • Dose 2 (Morning of Procedure): Beginning approximately 3 to 8 hours prior to the procedure, repeat the process by drinking 240 mL (8 ounces) every 10 minutes until the remaining 2 liters are finished.
  • Completion Deadline: All solution and additional clear liquids must be finished at least 2 hours before the scheduled colonoscopy or anesthesia start time.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Clinical Efficacy & Research

Four-liter PEG-electrolyte solutions remain the gold standard in bowel preparation due to their exceptional safety profile across diverse patient populations. Because GoLYTELY is iso-osmotic, it does not induce significant fluid or electrolyte shifts, making it preferred for high-risk patients with renal failure, cardiac disease, or advanced liver disease. Clinical studies demonstrate that split-dose administration achieves high rates of adequate colon cleansing (often exceeding 90%), allowing gastroenterologists to reliably detect small adenomas and flat dysplastic lesions.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Side Effects & Safety Profile

BLACK BOX WARNING

This medication currently does not have an official FDA Black Box Warning.

Common Side Effects

  • Nausea and vomiting
  • Severe abdominal fullness and bloating
  • Stomach cramps or abdominal pain
  • Anal irritation and discomfort from frequent liquid movements
  • Chills or feeling cold during administration

Serious Adverse Events

  • Electrolyte Imbalances: Severe hyponatremia (low sodium) or hypokalemia (low potassium), potentially leading to neurological changes or cardiac issues.
  • Cardiac Arrhythmias: Abnormal heart rhythms triggered by transient fluid shifts or electrolyte stress in patients with underlying cardiac disease.
  • Seizures: Generalized tonic-clonic seizures associated with severe electrolyte disturbances, even in patients without a history of seizure disorders.
  • Aspiration Pneumonia: Accidental inhalation of the fluid into the lungs, primarily occurring in elderly patients or individuals with an impaired gag reflex who vomit during consumption.

Side Effect Management

If severe nausea, vomiting, or abdominal distension occurs while drinking the solution, slow the rate of consumption or temporarily pause drinking for 30 to 45 minutes until symptoms subside. Resuming at a slower pace helps manage gastric fullness.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Drug Interactions & Guidelines

Key Interactions

The rapid transit of fluid through the gastrointestinal tract severely diminishes the absorption of oral medications administered concurrently.

  • Oral Medications: Avoid taking oral medications within 1 hour before or after starting each dose of the prep. They may be flushed through the digestive tract without being absorbed.
  • Renal and Electrolyte Risk Drugs: Use with extreme caution in patients taking diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs), or NSAIDs, as combining these with bowel cleansing increases the risk of acute renal impairment.
  • Stimulant Laxatives: Combining with other OTC laxatives is unnecessary unless specifically instructed by your gastroenterologist.

Food & Drink Restrictions

  • Clear Liquid Diet: Patients must adhere to a strict clear liquid diet starting the day before the colonoscopy. Solid food is strictly prohibited once the clear liquid diet begins.
  • Prohibited Color Dyes: Do not consume liquids, gelatin, or popsicles containing red or purple dyes, as these can stain the mucosa and mimic blood.
  • Prohibited Items: Milk, dairy products, alcohol, and liquids containing pulp are not allowed.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Missed Dose, Overdose & Storage

Missed Dose

Completing the entire 4-liter jug is required for adequate bowel cleansing. If you start a dose late, finish it as quickly as tolerated within the recommended safety window. If you miss a significant portion of the dose and your procedure is imminent, contact your endoscopy facility immediately; your procedure may need to be rescheduled due to incomplete cleansing.

Overdose

An overdose (e.g., ingestion of far more than the recommended volume or rapid administration without excretion) can lead to severe fluid overload, metabolic alkalosis, profound electrolyte depletion, and life-threatening dehydration. Seek immediate emergency medical care for supportive management and intravenous electrolyte correction.

Storage Instructions

  • Unmixed Powder: Store dry powder at controlled room temperature between 20°C and 25°C (68°F to 77°F).
  • Reconstituted Solution: Once mixed with water, the solution must be stored in the refrigerator between 2°C and 8°C (36°F to 46°F) and consumed within 48 hours. Discard any unused portion after 48 hours.

POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS Patient Management & Guidelines

Dos and Don’ts

  • DO chill the reconstituted liquid in the refrigerator prior to drinking to mask its salty taste.
  • DO drink each 8-ounce glass quickly rather than sipping slowly over long periods to promote efficient bowel clearing.
  • DO remain in close proximity to a restroom once you begin taking the preparation.
  • DON’T add extra flavorings, sugars, or juices to the jug, as this alters the osmolarity and safety profile of the solution.
  • DON’T consume any solid food on the day prior to your colonoscopy.

Frequently Asked Questions

Why do I have to drink such a large volume of liquid?

GoLYTELY is an iso-osmotic preparation that relies on physical fluid volume to flush the colon clean. Because it is chemically balanced not to draw water out of your tissues or cause major electrolyte shifts, it requires 4 liters of fluid to clean the bowel safely.

How does GoLYTELY differ from sulfate-free preps like NuLYTELY?

GoLYTELY contains sodium sulfate, which gives it a distinctly salty flavor but helps maintain optimal osmotic balance. Sulfate-free alternatives like NuLYTELY remove the sodium sulfate to reduce the salty taste while delivering the same 4-liter volume.

What should I do if I experience severe nausea while drinking the liquid?

Pause drinking for 30 to 45 minutes to allow your stomach time to empty. Walking around your home can help move fluid through your digestive system before you resume drinking at a slower pace.

What should my stool look like when the prep is complete?

By the time you finish the second morning dose, your bowel movements should be a clear, pale yellow liquid without solid particles, looking very similar to pale urine. If your stool remains brown or thick, call your clinic right away.

Can I mix the powder with sports drinks or fruit juices?

No. You must mix the powder exclusively with plain drinking water. Adding juices, sports drinks, or sugar alters the delicate electrolyte and osmotic balance of the solution, which can compromise both safety and cleansing efficacy.

How can I make drinking the solution easier to tolerate?

Refrigerate the solution after mixing so it is cold, use a straw placed near the back of your tongue to bypass your taste buds, and suck on a lemon wedge or clear mint between glasses to clear your palate.

Can I take my daily prescription medications while drinking the prep?

Do not take oral medications within 1 hour before or after starting each dose of the prep. The rapid flushing action through your digestive tract can wash medications out before your body can absorb them.

References

  • U.S. Food and Drug Administration (FDA) – GoLYTELY (polyethylene glycol 3350 and electrolytes) prescribing information.
  • U.S. Food and Drug Administration (FDA) – Drugs@FDA Overview (Application No. 019011).
  • American Society for Gastrointestinal Endoscopy (ASGE) – Guidelines for Bowel Preparation Before Colonoscopy.

The information provided is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider regarding medical conditions or treatment plans.