PEG-3350/kcl /sod Lemon-Lime 4000ml
It is used to clean out the GI (gastrointestinal) tract.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Laxative, Bowel Evacuant
Pharmacologic Class
Osmotic Laxative; Electrolyte Solution
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a large volume liquid that you drink to completely clean out your bowels before a medical procedure like a colonoscopy. It works by drawing water into your intestines, causing you to have many watery bowel movements until your stool is clear.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided and follow the instructions closely. Your doctor will advise you on when to take the medication, which foods and drinks to avoid before the exam, and when to stop eating and drinking before the exam. If you have any questions or concerns, be sure to discuss them with your doctor.
Important Administration Instructions
Do not take any other oral medications within 1 hour before each dose of this medication. Some medications may require a longer separation time, so consult your doctor for guidance on taking other medications with this one.
Mix the medication with water as instructed before taking it. Do not swallow the dry powder.
Avoid mixing the medication with starch-based thickeners.
If your product comes with flavorings, only use the flavors provided with the kit.
Chilling the solution may improve the taste, but do not give chilled solution to an infant. Consult your doctor for advice.
Shake the solution well before use.
Drink clear liquids before, during, and after taking the medication. Avoid drinking liquids that are purple or red, as well as milk and alcohol.
Do not eat solid food while taking this medication.
Storage and Disposal
Store the powder at room temperature.
After mixing, store the solution in the refrigerator. If you have questions about the storage duration after mixing, consult your doctor or pharmacist.
Do not freeze the solution.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
If you are unable to finish the medication before your exam, contact your doctor for guidance.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided and follow the instructions closely. Your doctor will advise you on when to take the medication, which foods and drinks to avoid before the exam, and when to stop eating and drinking before the exam. If you have any questions or concerns, be sure to discuss them with your doctor.
Important Administration Instructions
Do not take any other oral medications within 1 hour before each dose of this medication. Some medications may require a longer separation time, so consult your doctor for guidance on taking other medications with this one.
Mix the medication with water as instructed before taking it. Do not swallow the dry powder.
Avoid mixing the medication with starch-based thickeners.
If your product comes with flavorings, only use the flavors provided with the kit.
Chilling the solution may improve the taste, but do not give chilled solution to an infant. Consult your doctor for advice.
Shake the solution well before use.
Drink clear liquids before, during, and after taking the medication. Avoid drinking liquids that are purple or red, as well as milk and alcohol.
Do not eat solid food while taking this medication.
Storage and Disposal
Store the powder at room temperature.
After mixing, store the solution in the refrigerator. If you have questions about the storage duration after mixing, consult your doctor or pharmacist.
Do not freeze the solution.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
If you are unable to finish the medication before your exam, contact your doctor for guidance.
Lifestyle & Tips
- Follow a clear liquid diet as instructed by your doctor, typically starting the day before the procedure.
- Do not consume solid food, milk, or alcohol during the preparation period.
- Stay well-hydrated by drinking additional clear liquids (water, clear broth, apple juice, clear sodas) in addition to the prescribed solution.
- Plan to be near a toilet for several hours after starting the solution, as bowel movements will be frequent and watery.
- Avoid red or purple liquids or gelatin, as they can stain the colon and interfere with the procedure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
4 liters (L) of solution orally, typically consumed at a rate of 240 mL (8 oz) every 10 to 15 minutes until the entire volume is consumed or rectal effluent is clear. Administration usually begins the evening before the procedure or split-dose regimen.
Dose Range:
4000 - 4000 mg
Condition-Specific Dosing:
colonoscopy_prep:
4 L orally, typically 2 L the evening before and 2 L on the morning of the procedure (split-dose regimen) or 4 L the evening before (day-before regimen).
constipation:
Not typically used for chronic constipation; primarily for bowel cleansing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing for bowel preparation in infants and children is typically weight-based (e.g., 25 mL/kg/hour for 4 hours, or 25-40 mL/kg/hour until rectal effluent is clear, up to 4 L total). Specific dosing should be guided by a physician.
Child:
Dosing for bowel preparation in infants and children is typically weight-based (e.g., 25 mL/kg/hour for 4 hours, or 25-40 mL/kg/hour until rectal effluent is clear, up to 4 L total). Specific dosing should be guided by a physician.
Adolescent:
Similar to adult dosing, 4 L orally, but may be adjusted based on weight and tolerance.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but monitor electrolytes.
Moderate:
Use with caution. Monitor fluid and electrolyte status closely, especially in patients with impaired renal function, as electrolyte imbalances (e.g., hypermagnesemia, hyperphosphatemia) can occur with other bowel preparations, though less common with balanced PEG-ELS.
Severe:
Use with extreme caution or avoid. Contraindicated in patients with severe renal impairment due to potential for fluid and electrolyte shifts. Close monitoring of fluid and electrolytes is critical if used.
Dialysis:
Contraindicated or use with extreme caution and close medical supervision due to risk of fluid overload and severe electrolyte disturbances.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Polyethylene glycol (PEG) is an inert, non-absorbable osmotic agent that causes water to be retained in the bowel lumen. This increases the intraluminal volume, leading to distension, which stimulates peristalsis and promotes rapid evacuation of the bowel. The electrolyte components (sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) are included to prevent significant shifts in fluid and electrolytes across the intestinal wall, maintaining isotonicity and preventing dehydration or electrolyte imbalance.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (minimal)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Should be administered on an empty stomach after a period of clear liquid diet.
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (excreted unchanged in feces)
Clearance:
Not applicable
ExcretionRoute:
Fecal (unchanged)
Unchanged:
>98%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (first bowel movement)
PeakEffect:
Variable, continues until solution is consumed and bowel is clear (typically 4-6 hours)
DurationOfAction:
Until bowel is completely evacuated (several hours after last dose)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
+ Swelling of the abdomen
Severe headache
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Rectal bleeding or pain
This medication may also cause dehydration or electrolyte imbalances, which can be severe or life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Dizziness or fainting
Fatigue or weakness
Inability to pass urine
Fast or irregular heartbeat
Seizures
Headache
Mood changes
Confusion
Muscle pain or weakness
Increased thirst
Decreased appetite
Dry mouth or eyes
Severe nausea or vomiting
Changes in urine output
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Stomach pain
Anal irritation
Bloating
Feeling full
Nausea or vomiting
Stomach cramps
Sleep disturbances
Increased appetite
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
+ Swelling of the abdomen
Severe headache
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Rectal bleeding or pain
This medication may also cause dehydration or electrolyte imbalances, which can be severe or life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Dizziness or fainting
Fatigue or weakness
Inability to pass urine
Fast or irregular heartbeat
Seizures
Headache
Mood changes
Confusion
Muscle pain or weakness
Increased thirst
Decreased appetite
Dry mouth or eyes
Severe nausea or vomiting
Changes in urine output
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Stomach pain
Anal irritation
Bloating
Feeling full
Nausea or vomiting
Stomach cramps
Sleep disturbances
Increased appetite
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain or distension (more than mild cramping)
- Persistent vomiting that prevents you from completing the preparation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of severe dehydration (extreme thirst, very dry mouth, no urination, fainting)
- Rectal bleeding (more than a few streaks)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel problems, such as a bowel block or hole in the bowel
+ Electrolyte imbalances (e.g., sodium, potassium, phosphate)
+ Dehydration (fluid loss)
+ Previous stomach or bowel surgery
This list is not exhaustive, and it is crucial to discuss all your medications and health issues with your doctor.
To ensure your safety, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health, including any existing medical conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm it is safe for you to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel problems, such as a bowel block or hole in the bowel
+ Electrolyte imbalances (e.g., sodium, potassium, phosphate)
+ Dehydration (fluid loss)
+ Previous stomach or bowel surgery
This list is not exhaustive, and it is crucial to discuss all your medications and health issues with your doctor.
To ensure your safety, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health, including any existing medical conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Unless directed by your doctor, do not use any other laxatives or stool softeners in conjunction with this drug.
If you have phenylketonuria (PKU), it is crucial to discuss this with your doctor, as some formulations of this medication may contain phenylalanine.
For individuals over 60 years of age, caution is advised when using this medication, as you may be more susceptible to side effects.
While some medications can be used in pediatric patients, caution is necessary when administering this drug to children. It is recommended to consult with your doctor to determine if this medication is suitable for children and to discuss any concerns you may have about giving this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to inform your doctor. Your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Unless directed by your doctor, do not use any other laxatives or stool softeners in conjunction with this drug.
If you have phenylketonuria (PKU), it is crucial to discuss this with your doctor, as some formulations of this medication may contain phenylalanine.
For individuals over 60 years of age, caution is advised when using this medication, as you may be more susceptible to side effects.
While some medications can be used in pediatric patients, caution is necessary when administering this drug to children. It is recommended to consult with your doctor to determine if this medication is suitable for children and to discuss any concerns you may have about giving this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to inform your doctor. Your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe electrolyte imbalance (e.g., hypernatremia, hyperkalemia, hypokalemia)
- Severe dehydration
- Metabolic acidosis or alkalosis
- Cardiac arrhythmias
- Seizures
- Renal failure
What to Do:
Discontinue medication immediately. Seek emergency medical attention. Management is supportive, focusing on correction of fluid and electrolyte imbalances. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Oral medications taken within 1 hour of starting PEG-ELS solution: May be flushed from the GI tract and not absorbed. Consider adjusting timing of essential medications (e.g., oral contraceptives, anti-epileptics, diabetes medications).
Moderate Interactions
- Diuretics: Increased risk of fluid and electrolyte imbalance, especially hypokalemia, if not adequately hydrated.
- ACE inhibitors/ARBs: Increased risk of electrolyte abnormalities (e.g., hyperkalemia if combined with other factors).
- NSAIDs: Increased risk of renal impairment in dehydrated patients.
- Laxatives (other): Concurrent use may increase risk of adverse GI effects (e.g., severe cramping, dehydration).
Monitoring
Baseline Monitoring
Electrolytes (Na, K, Cl, HCO3)
Rationale: To establish baseline and identify pre-existing imbalances, especially in patients with renal, cardiac, or hepatic impairment, or those on diuretics.
Timing: Prior to administration, particularly in high-risk patients.
Renal function (BUN, Creatinine)
Rationale: To assess kidney function, as severe impairment is a contraindication or requires extreme caution.
Timing: Prior to administration, particularly in high-risk patients.
Hydration status
Rationale: To ensure patient is adequately hydrated before starting bowel prep.
Timing: Prior to administration.
Routine Monitoring
Fluid intake and output
Frequency: During and after administration
Target: Adequate intake to match output, clear rectal effluent
Action Threshold: Signs of dehydration (decreased urine output, dry mucous membranes, orthostasis)
Electrolytes
Frequency: Post-procedure, if concerns arise (e.g., signs of imbalance, high-risk patient)
Target: Within normal limits
Action Threshold: Significant deviations from baseline or normal range
Vital signs (BP, HR)
Frequency: Periodically during administration, if patient reports symptoms
Target: Stable
Action Threshold: Orthostatic hypotension, tachycardia, signs of hypovolemia
Symptom Monitoring
- Abdominal cramping or bloating (common)
- Nausea or vomiting (common, may indicate too rapid ingestion)
- Anal irritation
- Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
- Signs of electrolyte imbalance (muscle weakness, irregular heartbeat, confusion, seizures - rare but serious)
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal, adequate studies in pregnant women are lacking. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but data are limited.
Second Trimester:
Minimal systemic absorption suggests low risk, but data are limited.
Third Trimester:
Minimal systemic absorption suggests low risk, but data are limited. Dehydration risk should be managed.
Lactation
L1 (Safest). Minimal systemic absorption of PEG-3350 and electrolytes means negligible excretion into breast milk. Considered compatible with breastfeeding.
Infant Risk:
Low risk to infant.
Pediatric Use
Used for bowel preparation in children, but dosing is weight-based and requires careful monitoring of fluid and electrolyte status, especially in younger or smaller children. Risk of dehydration and electrolyte imbalance may be higher.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing renal impairment, cardiac disease, or electrolyte abnormalities. They may be more susceptible to fluid and electrolyte disturbances. Monitor closely for signs of dehydration and electrolyte imbalance.
Clinical Information
Clinical Pearls
- Chilling the solution can improve palatability. Adding clear, sugar-free flavorings (e.g., lemon, lime, orange) can also help, but avoid red/purple dyes.
- Ingest the solution at the recommended rate (e.g., 8 oz every 10-15 minutes) to minimize nausea and ensure completion.
- Patients should remain well-hydrated with additional clear liquids throughout the prep process to prevent dehydration.
- Advise patients to use a barrier cream (e.g., petroleum jelly, zinc oxide) around the anus to prevent irritation from frequent bowel movements.
- Ensure patients understand the importance of completing the entire prescribed volume for effective bowel cleansing.
- For split-dose regimens, emphasize the importance of waking up early to complete the second half of the prep several hours before the procedure.
Alternative Therapies
- Sodium Phosphate preparations (e.g., OsmoPrep, Visicol - less common now due to renal risks)
- Magnesium Citrate
- Oral Sodium Sulfate solutions
- Stimulant laxatives (e.g., Bisacodyl, Senna) in combination with other agents
Cost & Coverage
Average Cost:
$20 - $100+ per 4L kit
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans for indicated use)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.