Gavilyte-C Solution 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
Bowel Cleansing Agent; Laxative, Osmotic
Pharmacologic Class
Polyethylene Glycol-Electrolyte Solution
Pregnancy Category
Category C
FDA Approved
Sep 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gavilyte-C is a large volume liquid medicine 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 to ensure your colon is empty.
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, don't hesitate to discuss them with your doctor.
Important Administration Instructions
Do not take any other oral medications within 1 hour of taking this drug. In some cases, your doctor may advise a longer separation time between medications. Consult your doctor for guidance on taking your other medications in conjunction 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 its taste, but do not give a 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 consume solid food while taking this medication.
Storage and Disposal
Store the powder at room temperature.
After mixing, refrigerate the solution. If you're unsure about how long the mixed solution can be used, 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's 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 extra doses.
If you're unable to complete the medication before your exam, contact your doctor for guidance.
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, don't hesitate to discuss them with your doctor.
Important Administration Instructions
Do not take any other oral medications within 1 hour of taking this drug. In some cases, your doctor may advise a longer separation time between medications. Consult your doctor for guidance on taking your other medications in conjunction 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 its taste, but do not give a 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 consume solid food while taking this medication.
Storage and Disposal
Store the powder at room temperature.
After mixing, refrigerate the solution. If you're unsure about how long the mixed solution can be used, 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's 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 extra doses.
If you're unable to complete the medication before your exam, contact your doctor for guidance.
Lifestyle & Tips
- Follow a clear liquid diet starting the day before your procedure, as instructed by your doctor. No solid foods.
- Drink the entire prescribed amount of solution, even if you feel full or nauseous. It's crucial for a successful procedure.
- Drink the solution at the recommended rate (e.g., 8 ounces every 10-15 minutes) to avoid nausea and ensure effectiveness.
- Stay near a toilet once you start drinking the solution, as bowel movements will be frequent and urgent.
- Stay well-hydrated with other clear liquids (water, clear broth, apple juice, clear sodas, sports drinks without red/purple dye) in addition to the Gavilyte-C.
- Avoid red or purple liquids or gelatin, as they can stain the colon and be mistaken for blood during the procedure.
- Do not take any solid food or milk products after starting the solution until after your procedure.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
4 liters (L) orally, typically as 240 mL (8 oz) every 10-15 minutes until the entire solution 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_preparation:
4 L orally, administered over 2-3 hours (e.g., 240 mL every 10-15 minutes). May be given as a split-dose: 2 L the evening before and 2 L on the morning of the procedure (at least 3-5 hours prior to procedure, finishing at least 2 hours before).
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based and requires careful monitoring. Typically 25 mL/kg/hour for 4 hours or 15 mL/kg/hour for 10 hours, up to 4 L total.
Child:
Dosing is weight-based. Typically 25 mL/kg/hour for 4 hours or 15 mL/kg/hour for 10 hours, up to 4 L total. Max 4 L.
Adolescent:
Similar to adult dosing, 4 L orally, administered over 2-3 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
Use with caution; monitor fluid and electrolyte status.
Severe:
Use with extreme caution; contraindicated in severe renal impairment due to risk of electrolyte imbalance and fluid overload. Consider alternative preparations or close monitoring if absolutely necessary.
Dialysis:
Contraindicated or use with extreme caution and close monitoring of fluid and electrolytes. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required, but monitor for fluid and electrolyte shifts, especially if ascites or significant edema are present.
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 leads to a large volume of unabsorbed fluid, which distends the colon and induces powerful peristalsis, resulting in rapid evacuation of the bowel. The electrolyte components (sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) are included to prevent significant fluid and electrolyte shifts across the intestinal wall, maintaining isotonicity and preventing dehydration or electrolyte imbalance.
Pharmacokinetics
Absorption:
Bioavailability:
<1%
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Should be taken on an empty stomach or after a clear liquid diet to ensure effective bowel cleansing.
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (excreted unchanged)
Clearance:
Not applicable (minimal systemic clearance)
ExcretionRoute:
Fecal (nearly 100% unchanged)
Unchanged:
>99%
Pharmacodynamics
OnsetOfAction:
1-3 hours (first bowel movement)
PeakEffect:
Within 4-6 hours (most active bowel movements)
DurationOfAction:
Until the entire solution is consumed and bowel contents are cleared, typically 4-6 hours after completion of dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate 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 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
Trouble sleeping
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.
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 immediate 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 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
Trouble sleeping
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.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain or cramping that does not subside.
- Persistent or severe nausea and vomiting that prevents you from drinking the solution.
- Signs of severe dehydration, such as extreme thirst, dizziness, lightheadedness, fainting, or significantly decreased urination.
- New or worsening rectal bleeding.
- Allergic reaction symptoms like rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
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. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
To ensure your safety, verify that it is acceptable to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
To ensure your safety, verify that it is acceptable to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 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.
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 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.
Overdose Information
Overdose Symptoms:
- Severe dehydration
- Significant electrolyte imbalances (e.g., hypernatremia, hyperkalemia, metabolic acidosis)
- Severe abdominal distension
- Vomiting
- Diarrhea leading to fluid loss
What to Do:
Discontinue the solution immediately. Provide supportive care, including fluid and electrolyte replacement as needed. Monitor vital signs and electrolyte levels. In case of severe symptoms or suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Contraindicated Interactions
- Gastrointestinal obstruction or ileus
- Bowel perforation
- Toxic colitis
- Toxic megacolon
- Gastric retention
Major Interactions
- Oral medications (taken within 1 hour of starting or during PEG-ELS administration, as absorption may be reduced or prevented)
- Diuretics (increased risk of electrolyte imbalance, especially hypokalemia)
- ACE inhibitors/ARBs (increased risk of electrolyte imbalance, especially hyperkalemia if renal function is impaired)
- NSAIDs (increased risk of renal impairment in dehydrated patients)
- Laxatives (additive effect, increased risk of dehydration and electrolyte imbalance)
Moderate Interactions
- Antidiabetic agents (potential for transient hypoglycemia due to fluid shifts and reduced oral intake)
- Antiepileptic drugs (potential for reduced absorption and loss of seizure control)
- Oral contraceptives (potential for reduced absorption and decreased efficacy)
Minor Interactions
- Not many specific minor interactions beyond general reduced absorption of oral medications.
Monitoring
Baseline Monitoring
Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)
Rationale: To establish baseline levels, especially in patients with pre-existing renal impairment, heart failure, or those on medications affecting electrolytes.
Timing: Prior to initiation of therapy, if clinically indicated.
Renal Function (BUN, Creatinine)
Rationale: To assess kidney function, as severe renal impairment is a contraindication or requires extreme caution.
Timing: Prior to initiation of therapy, if clinically indicated.
Hydration Status
Rationale: To assess baseline hydration and identify patients at risk for dehydration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Fluid Intake and Output
Frequency: During and after administration until bowel movements cease.
Target: Adequate intake to match output, clear rectal effluent.
Action Threshold: Signs of dehydration (decreased urine output, dry mucous membranes, orthostasis) or fluid overload.
Electrolytes (Sodium, Potassium)
Frequency: If clinically indicated (e.g., in patients with renal impairment, heart failure, or those experiencing significant vomiting/diarrhea).
Target: Within normal limits.
Action Threshold: Significant deviations from normal range (e.g., hypokalemia, hyponatremia).
Vital Signs (Blood Pressure, Heart Rate)
Frequency: Periodically during administration, especially in elderly or frail patients.
Target: Stable.
Action Threshold: Orthostatic hypotension, tachycardia, or other signs of dehydration.
Symptom Monitoring
- Abdominal pain or cramping (severe or persistent)
- Nausea and vomiting (persistent or severe)
- Bloating or distension (severe)
- Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
- Rectal bleeding (new or worsening)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, reducing fetal exposure.
Trimester-Specific Risks:
First Trimester:
Limited data, but minimal systemic absorption suggests low risk. Use only if clearly indicated.
Second Trimester:
Limited data, but minimal systemic absorption suggests low risk. Use only if clearly indicated.
Third Trimester:
Limited data, but minimal systemic absorption suggests low risk. Monitor for fluid and electrolyte shifts in the mother, which could indirectly affect the fetus.
Lactation
Considered low risk. Polyethylene glycol is minimally absorbed systemically, and therefore, excretion into breast milk is expected to be negligible. Breastfeeding can generally continue.
Infant Risk:
Low risk. No adverse effects on breastfed infants are expected due to minimal maternal absorption and excretion into milk.
Pediatric Use
Used for bowel preparation in children, but dosing is weight-based and requires careful calculation and monitoring, especially in younger children and infants, due to higher risk of fluid and electrolyte imbalances. Ensure adequate hydration.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing renal impairment, heart failure, or electrolyte abnormalities. They are at increased risk for dehydration, electrolyte disturbances, and cardiac arrhythmias. Close monitoring of fluid status, electrolytes, and vital signs is recommended.
Clinical Information
Clinical Pearls
- Ensure the patient understands the importance of consuming the entire volume for effective bowel cleansing.
- Advise patients to chill the solution and/or add flavor packets (if provided and approved) to improve palatability.
- Instruct patients to drink the solution at the recommended rate to minimize nausea and vomiting.
- Emphasize the importance of a clear liquid diet before and during the preparation.
- Remind patients that the goal is clear, yellowish liquid stool without solid particles.
- Caution patients about potential for bloating, nausea, and abdominal cramping, which are common side effects.
- Advise patients to stay well-hydrated with other clear liquids in addition to the prep solution.
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)
- Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate (e.g., Suprep)
- Oral Sodium Sulfate/Magnesium Sulfate/Potassium Chloride (e.g., Plenvu)
Cost & Coverage
Average Cost:
$20 - $80 per 4L kit
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by most insurance plans, especially for colonoscopy preparation)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor immediately. It's essential to keep your medication to yourself and not take anyone else's prescription. This medication includes a Medication Guide, which provides important 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, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, call the poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.