PEG-3350 & Electrolytes Flavored

Manufacturer STRIDES PHARMA Active Ingredient Polyethylene Glycol-Electrolyte Solution Prep(pol i ETH i leen GLY kol ee LEK troe lite soe LOO shun) Pronunciation POL-ee-ETH-i-leen GLY-kol ee-LEK-troe-lite soe-LOO-shun
It is used to clean out the GI (gastrointestinal) tract.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Bowel Cleansing Agent; Laxative, Osmotic
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Pharmacologic Class
Polyethylene Glycol-Electrolyte Solution
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a large-volume laxative solution used to completely clean out your bowels before a colonoscopy or other medical procedure. It works by drawing a lot of water into your intestines, which helps you have frequent, watery bowel movements to clear out all solid waste. The electrolytes in it help prevent your body from losing too much fluid or important salts.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines. Take your medication as directed by your doctor, paying attention to the timing, any food or drink restrictions before your exam, and when to stop eating and drinking beforehand. If you have any questions or concerns, discuss them with your doctor.

Important Administration Instructions

Do not take any other oral medications within 1 hour of taking this medication. In some cases, your doctor may advise a longer separation time between medications. Consult with your doctor to determine the best schedule for taking your 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 medication comes with flavorings, only use the flavors provided in the kit.
Chilling the solution may improve its taste, but do not give a chilled solution to an infant. Consult with your doctor for guidance.
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 consume solid food while taking this medication.

Storage and Disposal

Store the powder at room temperature.
After mixing, refrigerate the solution. If you are unsure about how long the mixed solution can be used, consult with 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 complete the medication before your exam, contact your doctor for guidance.
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Lifestyle & Tips

  • Follow all dietary restrictions given by your doctor (e.g., clear liquid diet) before, during, and after taking the solution.
  • Drink the solution as directed, typically 240 mL (8 ounces) every 10-15 minutes, until the entire amount is consumed or your bowel movements are clear and watery.
  • Stay near a toilet once you start drinking the solution, as bowel movements will be frequent and urgent.
  • Keep well-hydrated with clear liquids (water, clear broth, apple juice, clear sodas) in addition to the solution, unless otherwise instructed.
  • Avoid red or purple liquids or foods, as they can stain the colon and interfere with the procedure.
  • Do not take any solid food once you start the bowel prep until after your procedure.

Dosing & Administration

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Adult Dosing

Standard Dose: For bowel cleansing prior to colonoscopy: 4 liters of solution, administered orally or via nasogastric tube. Typically, 240 mL (8 fl oz) every 10 to 15 minutes until the entire 4 liters are consumed or the rectal effluent is clear and free of solid material. Split-dose regimens are common (e.g., 2 liters the evening before, 2 liters the morning of the procedure).
Dose Range: 4000 - 4000 mg

Condition-Specific Dosing:

colonoscopy_prep: 4 liters total, administered over 2-3 hours for single dose or split over two days for split dose.
chronic_constipation: Not typically used for chronic constipation in this large volume electrolyte-balanced formulation; PEG-3350 alone is used for this indication.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for bowel prep; for chronic constipation, 0.5-1 g/kg/day of PEG-3350 alone.
Child: For bowel cleansing: 25 mL/kg/hour for 4 hours (total dose 100 mL/kg, max 4 liters). For chronic constipation: 0.5-1 g/kg/day of PEG-3350 alone.
Adolescent: Similar to adult dosing for bowel cleansing (4 liters total), or 25 mL/kg/hour for 4 hours (max 4 liters). For chronic constipation: 0.5-1 g/kg/day of PEG-3350 alone.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor electrolytes.
Moderate: Use with caution, monitor fluid and electrolyte status closely. Consider lower volume or alternative if severe electrolyte imbalance risk.
Severe: Use with extreme caution or avoid. Significant risk of fluid and electrolyte disturbances. Close monitoring of electrolytes, renal function, and fluid balance is critical. May require hospitalization for administration.
Dialysis: Generally contraindicated or used with extreme caution under strict medical supervision due to risk of fluid overload and severe electrolyte shifts. Consult nephrologist.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor fluid and electrolyte status, especially if ascites or significant edema are present.

Pharmacology

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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, thus minimizing the risk of dehydration or electrolyte imbalance during the rapid fluid loss.
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Pharmacokinetics

Absorption:

Bioavailability: <2% (systemic absorption)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Should be administered on an empty stomach or after a light, clear liquid diet.

Distribution:

Vd: Not applicable (primarily confined to GI lumen)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily excreted unchanged in feces.
Unchanged: >98%
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Pharmacodynamics

OnsetOfAction: Bowel movement typically begins within 1-2 hours of the first dose.
PeakEffect: Continuous bowel movements until solution is consumed and bowel is clear.
DurationOfAction: Effects persist until the bowel is completely evacuated, typically 4-6 hours after starting the solution, or longer depending on individual bowel motility.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

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 immediately:

Dizziness or fainting
Fatigue or weakness
Inability to pass urine
Fast or abnormal 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 or any other symptoms that bother you or do not go away, contact your doctor:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain or cramping that does not subside
  • Persistent nausea or vomiting that prevents you from drinking the solution
  • Signs of dehydration: extreme thirst, dry mouth, dizziness, lightheadedness, decreased urination
  • Signs of electrolyte imbalance: muscle weakness, muscle cramps, irregular heartbeat, confusion, seizures
  • Rectal bleeding (more than just streaks)
  • Allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing
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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 obstruction, perforation, or other bowel problems
+ 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. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To avoid potential interactions, do not use other laxatives or stool softeners unless your doctor advises you to do so.

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.

Adults over 60 years old should exercise caution when using this drug, as they may be more susceptible to side effects.

When considering the use of this medication in children, it is crucial to exercise caution. Discuss with your doctor to determine if this medication is suitable for children and to address any questions or concerns you may have about administering it to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe diarrhea
  • Significant fluid and electrolyte imbalance (e.g., severe dehydration, hypokalemia, hypernatremia, metabolic acidosis/alkalosis)
  • Abdominal distension
  • Nausea, vomiting
  • Cardiac arrhythmias (due to electrolyte shifts)
  • Seizures (due to severe electrolyte imbalance)

What to Do:

Discontinue the medication immediately. Provide supportive care, including fluid and electrolyte replacement as needed. Monitor vital signs, fluid balance, and electrolyte levels closely. In severe cases, hospitalization may be required. Call 911 or Poison Control (1-800-222-1222) immediately.

Drug Interactions

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Major Interactions

  • Oral medications (within 1 hour of starting solution): May be flushed from the GI tract and not absorbed. Administer oral medications at least 1 hour before starting PEG-3350 & Electrolytes solution.
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Moderate Interactions

  • Diuretics (especially loop or thiazide diuretics): Increased risk of fluid and electrolyte disturbances (e.g., hypokalemia, hyponatremia, dehydration). Monitor electrolytes closely.
  • ACE inhibitors/ARBs: Increased risk of electrolyte disturbances (e.g., hyperkalemia, hyponatremia) and renal impairment, especially in patients with pre-existing renal dysfunction or dehydration. Monitor electrolytes and renal function.
  • NSAIDs: Increased risk of fluid and electrolyte disturbances and renal impairment, especially in patients with pre-existing renal dysfunction or dehydration. Monitor electrolytes and renal function.
  • Laxatives (other): Concurrent use may lead to excessive fluid loss and electrolyte imbalance.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Rationale: To establish baseline levels, especially in patients at risk for electrolyte abnormalities (e.g., renal impairment, heart failure, concomitant medications like diuretics).

Timing: Prior to administration, if clinically indicated.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal status, as severe renal impairment increases risk of fluid/electrolyte disturbances.

Timing: Prior to administration, if clinically indicated.

Fluid Status

Rationale: To assess baseline hydration and identify patients at risk for dehydration or fluid overload.

Timing: Prior to administration.

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Routine Monitoring

Fluid Intake and Output

Frequency: During and after administration until bowel movements cease.

Target: Output should be clear and free of solid material; adequate hydration maintained.

Action Threshold: Signs of dehydration (decreased urine output, dry mucous membranes, orthostasis) or fluid overload (edema, dyspnea).

Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Frequency: Post-procedure or if symptoms of imbalance occur, especially in high-risk patients (e.g., elderly, renal/cardiac impairment, concomitant medications).

Target: Within normal limits.

Action Threshold: Significant deviations from normal range (e.g., hypokalemia <3.5 mEq/L, hyponatremia <135 mEq/L).

Vital Signs (BP, HR)

Frequency: Periodically during administration and post-procedure, especially if symptoms of dehydration or cardiovascular compromise.

Target: Stable, within patient's baseline.

Action Threshold: Orthostatic hypotension, tachycardia, signs of shock.

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Symptom Monitoring

  • Severe abdominal pain or bloating
  • Nausea or vomiting that prevents completion of the prep
  • Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
  • Signs of electrolyte imbalance (muscle cramps, weakness, irregular heartbeat, confusion, seizures)
  • Rectal bleeding
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Generally considered low risk due to minimal systemic absorption. However, use only if clearly needed and potential benefits outweigh risks. Category C due to lack of adequate, well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Minimal systemic absorption suggests low risk, but caution advised.
Second Trimester: Minimal systemic absorption suggests low risk.
Third Trimester: Minimal systemic absorption suggests low risk. Avoid use near term if possible to prevent potential electrolyte disturbances in mother that could indirectly affect fetus.
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Lactation

Considered compatible with breastfeeding due to minimal systemic absorption of PEG and electrolytes. It is unlikely to be excreted in breast milk in clinically significant amounts.

Infant Risk: L1 (Safest) - No adverse effects expected in breastfed infants.
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Pediatric Use

Use with caution, especially in younger children, due to higher risk of fluid and electrolyte imbalances. Dosing must be carefully calculated by weight. Ensure adequate hydration throughout the process. Contraindicated in children with suspected or known bowel obstruction, ileus, or toxic megacolon.

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Geriatric Use

Use with caution, especially in frail or debilitated elderly patients. They are at increased risk for fluid and electrolyte disturbances, dehydration, and cardiac arrhythmias. Monitor fluid status, electrolytes, and renal function closely. Ensure adequate hydration and consider slower administration if tolerated poorly.

Clinical Information

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Clinical Pearls

  • The 'flavored' versions are generally more palatable than unflavored, but chilling the solution can further improve taste.
  • Use a straw to drink the solution, placing it towards the back of the tongue to bypass taste buds.
  • Patients should be advised to stay near a toilet once they begin the prep, as bowel movements will be frequent and urgent.
  • Ensure patients understand the importance of completing the entire prescribed volume for effective bowel cleansing.
  • Advise patients to apply a barrier cream (e.g., petroleum jelly, zinc oxide) to the perianal area to prevent skin irritation from frequent bowel movements.
  • Instruct patients to stop drinking the solution if they experience severe abdominal pain, bloating, or persistent vomiting, and to contact their healthcare provider.
  • For split-dose regimens, ensure the patient understands the timing of the second dose, especially if it's very early in the morning.
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Alternative Therapies

  • Sodium Phosphate preparations (e.g., OsmoPrep, Visicol - less common now due to renal risk)
  • Magnesium Citrate
  • Sodium Picosulfate/Magnesium Oxide/Anhydrous Citric Acid (e.g., Prepopik)
  • Oral Sulfate Solution (e.g., Suprep Bowel Prep Kit)
  • Bisacodyl (often used as an adjunct)
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Cost & Coverage

Average Cost: Varies widely, typically $30 - $150+ per 4-liter kit
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, but may require prior authorization or be subject to specific formulary tiers. Generic versions are usually preferred.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

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 details about the medication taken, the amount consumed, and the time it occurred.