PEG 3350-Kcl-nacl Solution

Manufacturer TEVA Active Ingredient Polyethylene Glycol-Electrolyte Solution (MoviPrep, Plenvu)(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
Laxative, Bowel Evacuant
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Pharmacologic Class
Osmotic Laxative
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Pregnancy 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 strong laxative solution used to clean out your colon before a colonoscopy or other medical procedure. It works by causing you to have frequent, watery bowel movements to empty your intestines completely. It's important to drink all of the solution as directed to ensure a successful procedure.
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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 outlined below.

Take your medication exactly as directed by your doctor, including the timing, dosage, and any specific instructions related to food and drink before your exam.
If you have any questions or concerns, discuss them with your doctor to ensure you understand the instructions.
Avoid taking other oral medications within 1 hour of taking this drug, unless otherwise specified by your doctor. Some medications may require a longer separation time, so be sure to consult with your doctor about the best schedule for your other medications.
Prepare your medication by mixing it with water as instructed before taking it. Do not swallow the dry powder.
Do not mix your medication with starch-based thickeners.
If your medication 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. If you have concerns, consult with your doctor.
Shake the solution well before taking it.
Before, during, and after taking your medication, drink clear liquids. Avoid drinking liquids that are purple or red, as well as milk and alcohol.
Do not eat solid food while taking your medication.

Storing and Disposing of Your Medication

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 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.

What to Do If You Miss 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 your medication before your exam, contact your doctor for guidance.
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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 with clear liquids (water, clear broth, apple juice, clear sodas, sports drinks without red/purple dye) in addition to the prep solution.
  • Avoid red or purple colored liquids or foods, as they can mimic blood in the colon.
  • Plan to be near a toilet for several hours after starting the solution, as bowel movements will be frequent and watery.

Dosing & Administration

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Adult Dosing

Standard Dose: Typical regimens involve 2 to 4 liters of solution, administered orally. Common regimens include a split-dose (half the volume the evening before, half the morning of the procedure) or a single-dose (all volume the evening before or morning of). Specific instructions vary by product (e.g., MoviPrep: 2 liters total, Plenvu: 1 liter + 0.5 liter doses).
Dose Range: 2000 - 4000 mg

Condition-Specific Dosing:

Colonoscopy Preparation: Follow specific product instructions for volume and timing (e.g., split-dose or single-dose regimen). Ensure clear liquid diet is followed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine bowel preparation; specific formulations and weight-based dosing may be used for chronic constipation or specific procedures under medical supervision. Not typically recommended for general colonoscopy prep.
Adolescent: Not established for routine bowel preparation; specific formulations and weight-based dosing may be used for chronic constipation or specific procedures under medical supervision. Not typically recommended for general colonoscopy prep.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor electrolytes and hydration status.
Moderate: Use with caution; monitor electrolytes and hydration status closely. Consider reduced volume or alternative agents if risk of fluid/electrolyte imbalance is high.
Severe: Generally not recommended due to risk of fluid and electrolyte shifts, especially hypermagnesemia or hyperphosphatemia if present in formulation. If absolutely necessary, use with extreme caution and intensive electrolyte monitoring.
Dialysis: Generally not recommended. Consult nephrologist. Risk of severe fluid and electrolyte disturbances.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor for fluid and electrolyte balance.
Moderate: No specific dose adjustment typically required, but monitor for fluid and electrolyte balance, especially in patients with ascites or encephalopathy.
Severe: No specific dose adjustment typically required, but monitor for fluid and electrolyte balance, especially in patients with ascites or encephalopathy. Use with caution.

Pharmacology

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Mechanism of Action

Polyethylene Glycol (PEG) is an inert, non-absorbable, osmotically active substance that causes water to be retained in the bowel lumen. This increases the intraluminal volume, leading to distension, which stimulates peristalsis and promotes rapid bowel evacuation. The electrolyte components (potassium chloride, sodium chloride, sodium bicarbonate, sodium sulfate, sodium ascorbate, ascorbic acid, etc., depending on specific product) are included to prevent significant fluid and electrolyte shifts during the rapid bowel evacuation.
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Pharmacokinetics

Absorption:

Bioavailability: < 2% (PEG is minimally absorbed)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Should be taken on an empty stomach or after a clear liquid diet. Food intake will interfere with bowel cleansing.

Distribution:

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

Elimination:

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

OnsetOfAction: Within 1-3 hours of first dose
PeakEffect: Continuous bowel evacuation until solution is consumed and bowel is clear, typically within 4-6 hours of starting
DurationOfAction: Until bowel is completely evacuated, typically 4-6 hours after starting, but can continue for several hours depending on individual response
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 severe dehydration (e.g., extreme thirst, very little or no urination, dizziness, fainting)
  • Allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Rectal bleeding (more than just minor irritation from frequent wiping)
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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 allergic reaction and its symptoms.
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 conditions with your doctor.

To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history

Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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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.

Unless directed by your doctor, do not use any other laxatives or stool softeners in conjunction with this drug.

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

For individuals over 60 years old, exercise caution when using this medication, as you may be more susceptible to side effects.

If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), use this medication with caution, as it may increase the risk of anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.

If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dehydration
  • Significant electrolyte imbalance (e.g., hypokalemia, hypernatremia, hyponatremia)
  • Metabolic acidosis or alkalosis
  • Severe abdominal pain
  • Vomiting
  • Diarrhea leading to collapse

What to Do:

Discontinue use immediately. Seek emergency medical attention. Treatment is supportive, focusing on fluid and electrolyte correction. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Gastrointestinal obstruction or ileus
  • Bowel perforation
  • Toxic colitis or toxic megacolon
  • Gastric retention
  • Hypersensitivity to any component
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Major Interactions

  • Oral medications (taken within 1 hour of starting PEG-electrolyte solution or during the bowel prep period): May be flushed from the GI tract and not absorbed. Consider delaying or rescheduling critical medications.
  • Diuretics (especially loop or thiazide diuretics): Increased risk of dehydration and electrolyte imbalance (e.g., hypokalemia, hyponatremia).
  • ACE inhibitors/ARBs: Increased risk of dehydration and renal impairment, especially in patients with pre-existing renal dysfunction.
  • NSAIDs: Increased risk of renal impairment in dehydrated patients.
  • Laxatives (other types): Concurrent use may increase risk of severe dehydration or electrolyte imbalance.
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Moderate Interactions

  • Antidiabetic agents (oral or insulin): Blood glucose levels may fluctuate due to changes in diet and fluid intake. Monitor closely.
  • Drugs that prolong QT interval: Risk of arrhythmias in patients with electrolyte disturbances (e.g., hypokalemia, hypomagnesemia).
  • Drugs that affect renal function: Increased risk of acute kidney injury in dehydrated patients.

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 diuretic use).

Timing: Prior to initiation of bowel preparation, if clinically indicated.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, as dehydration or electrolyte shifts can exacerbate renal impairment.

Timing: Prior to initiation of bowel preparation, if clinically indicated.

Hydration Status

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

Timing: Prior to initiation of bowel preparation.

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Routine Monitoring

Fluid Intake and Output

Frequency: During and after bowel preparation

Target: Adequate intake to match output and prevent dehydration

Action Threshold: Signs of dehydration (decreased urine output, dry mucous membranes, orthostasis) or excessive fluid retention.

Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Frequency: Post-procedure or if symptoms of imbalance occur

Target: Within normal limits

Action Threshold: Significant deviations from normal range or symptomatic electrolyte imbalance (e.g., muscle weakness, arrhythmias).

Vital Signs (Blood Pressure, Heart Rate)

Frequency: During and after bowel preparation, especially if symptomatic

Target: Stable

Action Threshold: Orthostatic hypotension, tachycardia, or other signs of dehydration.

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Symptom Monitoring

  • Severe abdominal pain
  • Persistent nausea or vomiting
  • Bloating
  • Signs of dehydration (e.g., excessive thirst, dizziness, lightheadedness, decreased urination)
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Rectal bleeding (beyond minor irritation)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, but dehydration and electrolyte imbalances in the mother could theoretically affect the fetus. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Limited data, but minimal systemic absorption suggests low risk.
Second Trimester: Limited data, but minimal systemic absorption suggests low risk.
Third Trimester: Limited data, but minimal systemic absorption suggests low risk. Risk of dehydration in mother.
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Lactation

Minimal systemic absorption of PEG and electrolytes is expected, making it unlikely to be excreted in breast milk in clinically significant amounts. Generally considered compatible with breastfeeding, but caution is advised. Monitor infant for any changes in bowel habits.

Infant Risk: Low
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Pediatric Use

Generally not recommended for routine colonoscopy preparation in children without specific pediatric formulations or guidance. Dosing must be weight-based and carefully monitored due to higher risk of fluid and electrolyte disturbances in children. Specific products are approved for pediatric use for chronic constipation or specific procedures.

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Geriatric Use

Use with caution in elderly patients, who may be more susceptible to dehydration, electrolyte imbalances (especially hypokalemia, hyponatremia), and renal impairment. Monitor fluid status and electrolytes closely. Consider lower volumes or slower administration if tolerated.

Clinical Information

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Clinical Pearls

  • Ensure the patient understands the importance of drinking the entire prescribed volume for effective bowel cleansing.
  • Advise patients to chill the solution to improve palatability.
  • Suggest using a straw to bypass taste buds and drinking quickly rather than sipping.
  • Recommend applying a barrier cream (e.g., petroleum jelly, zinc oxide) to the perianal area to prevent skin irritation from frequent bowel movements.
  • Emphasize the importance of staying hydrated with additional clear liquids throughout the prep.
  • Instruct patients to stop drinking all liquids (including water) at the specified time before the procedure to avoid aspiration risk.
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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, and Anhydrous Citric Acid (e.g., Prepopik)
  • Oral Sulfate Solution (e.g., Suprep Bowel Prep Kit)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per bowel prep kit
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, typically Tier 2 or 3. Coverage may vary based on specific formulation and plan.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, 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 about its use. 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.