Gavilyte-G Solution 4000ml

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Polyethylene Glycol-Electrolyte Solution Prep(pol i ETH i leen GLY kol ee LEK troe lite soe LOO shun) Pronunciation GAV-ih-lite G (for Gavilyte-G); pol-ee-ETH-ih-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, 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?

Gavilyte-G is a strong laxative solution used to completely clean out your bowels before a colonoscopy or other medical procedure. It works by causing you to have frequent, watery bowel movements until your stool is clear. It's important to drink all of it as directed to ensure your colon is clean for the procedure.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure safe and effective use, follow your doctor's instructions for taking this medication. Read all the information provided and carefully follow the instructions. Take the medication as directed by your doctor, paying attention to the timing, any food or drink restrictions before the exam, and when to stop eating and drinking before the exam. If you have any questions, 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 a chilled solution to an infant. Consult your doctor for advice.
Shake the solution well before use.
Before, during, and after taking the 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 this medication.

Storage and Disposal

Store the powder at room temperature. After mixing, refrigerate the solution. 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 complete the medication before your exam, contact your doctor for guidance.
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Lifestyle & Tips

  • Follow a clear liquid diet starting the day before the procedure, as instructed by your doctor.
  • Do not eat any solid food from the time you start the preparation until after your procedure.
  • Stay well-hydrated with clear liquids (water, clear broth, apple juice, clear sodas, plain gelatin, popsicles) in addition to the Gavilyte-G solution.
  • Avoid red or purple liquids or gelatin, as they can stain the colon and interfere with the procedure.
  • Plan to be near a toilet for several hours after starting the solution, as bowel movements will be frequent and urgent.
  • Keep the solution chilled to improve palatability.

Dosing & Administration

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Adult Dosing

Standard Dose: 4 liters (4000 mL) orally, typically as 240 mL (8 fl oz) every 10 to 15 minutes until the entire solution is consumed or rectal effluent is clear. Administer over 2-3 hours.
Dose Range: 4000 - 4000 mg

Condition-Specific Dosing:

colonoscopy_prep: Administer the evening before the procedure or split-dose regimen (half the evening before, half on the morning of the procedure).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for bowel prep; specific formulations/doses for chronic constipation may exist.
Child: Typically 25 mL/kg/hour for 4 hours, or 1.5 L/m2 over 2-4 hours, or 25-40 mL/kg/hour until rectal effluent is clear. Max 4 liters. Specific protocols vary by institution and weight.
Adolescent: Similar to adult dosing, often 2-4 liters depending on weight and protocol.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor electrolytes.
Moderate: Use with caution; monitor electrolytes and hydration status closely. No specific dose adjustment due to minimal systemic absorption.
Severe: Use with extreme caution or avoid. Risk of electrolyte imbalance and fluid overload. Consider alternative bowel prep methods. Close monitoring of electrolytes and renal function is critical.
Dialysis: Generally contraindicated or used with extreme caution due to fluid and electrolyte shifts. Consult nephrologist.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

Pharmacology

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Mechanism of Action

Polyethylene glycol (PEG) is an osmotic agent that causes water to be retained in the colon. This increases the intraluminal volume, leading to distention and promoting bowel evacuation. The electrolyte components (sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) are included to prevent significant net absorption or secretion of ions, thereby minimizing fluid and electrolyte shifts during the bowel cleansing process.
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Pharmacokinetics

Absorption:

Bioavailability: <2% (PEG)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Administered on an empty stomach; food interferes with bowel cleansing.

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

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

OnsetOfAction: Approximately 1 hour (for first bowel movement)
PeakEffect: Continuous bowel movements until solution is consumed and bowel is clear
DurationOfAction: Until bowel is completely evacuated, typically 4-6 hours after initiation of dosing.

Safety & Warnings

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Side Effects

Serious 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
Feeling tired or weak
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 stomach upset 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 contact your doctor if you notice any of the following:

Stomach pain
Anal irritation
Bloating
Feeling full
Upset stomach or vomiting
Stomach cramps
Trouble sleeping
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.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain or bloating that does not go away
  • Persistent vomiting
  • Signs of dehydration (e.g., extreme thirst, dizziness, lightheadedness, decreased urination)
  • Rectal bleeding
  • Difficulty breathing
  • Irregular heartbeat
  • Muscle cramps or weakness
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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

To ensure your safety, always verify with your doctor that it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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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.

Do not use any other laxatives or stool softeners while taking this drug unless your doctor has instructed you to do so.

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may 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, caution is advised. Discuss with your doctor to determine if this drug is suitable for pediatric use and to address any questions or concerns you may have about administering this medication to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial 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 dehydration
  • Significant electrolyte imbalance (e.g., hypokalemia, hypernatremia, hyponatremia)
  • Metabolic acidosis or alkalosis
  • Cardiac arrhythmias
  • Seizures
  • Renal failure

What to Do:

Immediately seek emergency medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive, focusing on fluid and electrolyte correction.

Drug Interactions

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Contraindicated Interactions

  • Gastrointestinal obstruction or ileus
  • Bowel perforation
  • Toxic colitis
  • Toxic megacolon
  • Gastric retention
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Major Interactions

  • Oral medications (taken within 1 hour of starting or during administration)
  • Diuretics (increased risk of electrolyte imbalance, dehydration)
  • ACE inhibitors (increased risk of electrolyte imbalance, dehydration)
  • Angiotensin Receptor Blockers (ARBs) (increased risk of electrolyte imbalance, dehydration)
  • NSAIDs (increased risk of renal impairment in susceptible patients)
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Moderate Interactions

  • Laxatives (other types, additive effect)
  • Drugs that prolong QT interval (if significant electrolyte disturbances occur, e.g., hypokalemia)

Monitoring

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Baseline Monitoring

Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)

Rationale: To establish baseline and identify pre-existing imbalances, especially in patients with renal impairment, heart failure, or those on diuretics.

Timing: Prior to administration, especially in high-risk patients.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, as impaired renal function can increase risk of electrolyte disturbances.

Timing: Prior to administration, especially in high-risk patients.

Hydration Status

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

Timing: Prior to administration.

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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, persistent vomiting, inadequate bowel cleansing.

Electrolytes (Sodium, Potassium)

Frequency: Post-procedure or if symptoms of imbalance occur

Target: Within normal limits

Action Threshold: Significant deviations from baseline or normal range, especially in high-risk patients (e.g., renal impairment, heart failure, concomitant medications).

Vital Signs (BP, HR)

Frequency: As clinically indicated, especially if signs of dehydration or cardiovascular compromise

Target: Within patient's normal range

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Abdominal cramping/pain
  • Bloating
  • Dizziness
  • Weakness
  • Signs of dehydration (e.g., dry mouth, decreased urination, excessive thirst)
  • Signs of electrolyte imbalance (e.g., muscle cramps, irregular heartbeat, confusion)

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 suggests low risk, but data are limited.

Trimester-Specific Risks:

First Trimester: Limited data; theoretical risk of electrolyte imbalance in mother affecting fetus.
Second Trimester: Limited data; generally considered safer than first trimester if needed.
Third Trimester: Limited data; caution due to potential for dehydration and electrolyte shifts in mother.
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Lactation

L3 (Moderately Safe). Minimal systemic absorption of PEG suggests that it is unlikely to be excreted in breast milk in clinically significant amounts. Electrolytes are naturally present in milk. Generally considered compatible with breastfeeding, but monitor infant for diarrhea.

Infant Risk: Low risk of adverse effects due to minimal maternal absorption. Monitor for changes in infant's bowel habits.
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Pediatric Use

Use with caution, especially in younger children, due to higher risk of dehydration and electrolyte imbalance. Dosing is weight-based and requires careful monitoring. Ensure adequate hydration with clear liquids in addition to the prep solution.

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Geriatric Use

Use with caution. Elderly patients are at increased risk for dehydration, electrolyte disturbances (especially hypokalemia, hyponatremia), and renal impairment. Monitor fluid status, electrolytes, and renal function closely. Consider lower volumes or alternative preps if significant comorbidities exist.

Clinical Information

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Clinical Pearls

  • Chilling the solution can significantly improve palatability and patient compliance.
  • Adding clear, sugar-free flavor packets (e.g., Crystal Light) can help, but avoid red/purple colors.
  • Encourage patients to drink the solution quickly (e.g., through a straw) to minimize taste perception.
  • Advise patients to apply petroleum jelly or a barrier cream around the anus to prevent irritation from frequent bowel movements.
  • Ensure patients understand the importance of completing the entire preparation for a successful procedure.
  • 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 picosulfate, magnesium oxide, and anhydrous citric acid (e.g., Prepopik, Clenpiq)
  • Sodium phosphate preparations (e.g., OsmoPrep, Visicol - less commonly used due to renal risks)
  • Magnesium citrate
  • Oral sulfate solution (e.g., Suprep)
  • Bisacodyl tablets with magnesium citrate
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Cost & Coverage

Average Cost: $20 - $60 per 4L solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered by most insurance plans for indicated use)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.