Gavilyte-N Flavor Pack Solution
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 preparation, Osmotic laxative
Pharmacologic Class
Polyethylene Glycol-Electrolyte Solution
Pregnancy Category
C
FDA Approved
Sep 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gavilyte-N is a strong laxative solution used to clean out your bowels before a colonoscopy or other medical procedure. It works by causing you to have frequent, watery bowel movements to empty your colon completely.
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, preparation, and any specific instructions related to food and drink consumption before your exam.
If you have any questions or concerns, discuss them with your doctor to clarify any doubts.
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 approach.
Prepare your medication by mixing it with water as instructed before consumption. 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. Consult with your doctor for guidance.
Shake the solution well before use.
Drink clear liquids before, during, and after taking your medication. Avoid consuming purple or red liquids, milk, or alcohol.
Refrain from eating 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 are unsure about the storage duration after mixing, consult with your doctor or pharmacist.
Do not freeze the solution.
Keep all medications in a safe and secure location, out of 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 extra doses.
If you are unable to complete your medication regimen 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 outlined below.
Take your medication exactly as directed by your doctor, including the timing, preparation, and any specific instructions related to food and drink consumption before your exam.
If you have any questions or concerns, discuss them with your doctor to clarify any doubts.
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 approach.
Prepare your medication by mixing it with water as instructed before consumption. 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. Consult with your doctor for guidance.
Shake the solution well before use.
Drink clear liquids before, during, and after taking your medication. Avoid consuming purple or red liquids, milk, or alcohol.
Refrain from eating 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 are unsure about the storage duration after mixing, consult with your doctor or pharmacist.
Do not freeze the solution.
Keep all medications in a safe and secure location, out of 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 extra doses.
If you are unable to complete your medication regimen before your exam, contact your doctor for guidance.
Lifestyle & Tips
- Follow specific dietary instructions from your doctor (e.g., clear liquid diet) before and during administration.
- Stay well-hydrated with clear liquids (water, clear broth, apple juice, clear sodas) in addition to the solution.
- Do not eat solid food while taking the solution.
- Plan to be near a toilet for several hours after starting the solution.
- Avoid red or purple liquids or foods, as they can stain the colon and interfere with the procedure.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
4 liters (L) of solution orally, typically 240 mL (8 oz) every 10 to 15 minutes until the entire 4 L is consumed or rectal effluent is clear. Administer the evening before the procedure or split dose.
Condition-Specific Dosing:
colonoscopy_prep:
4 L orally, 240 mL every 10-15 minutes. Can be taken as a single dose the evening before or split dose (half evening before, half morning of procedure).
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based and requires careful electrolyte monitoring. Typically 25 mL/kg/hour for 4 hours or until rectal effluent is clear, up to 4 L total.
Child:
Dosing is weight-based. Typically 25 mL/kg/hour for 4 hours or until rectal effluent is clear, up to 4 L total.
Adolescent:
Similar to adult dosing, 4 L orally, 240 mL every 10-15 minutes.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but monitor electrolytes if concerns exist.
Moderate:
Use with caution; monitor electrolytes and hydration status closely.
Severe:
Use with caution; monitor electrolytes and hydration status closely. Contraindicated in patients with impaired gag reflex or predisposition to aspiration.
Dialysis:
Use with extreme caution; consult nephrologist. Risk of fluid and electrolyte shifts.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment.
Severe:
No specific adjustment.
Pharmacology
Mechanism of Action
Polyethylene Glycol (PEG) is an inert, non-absorbable osmotic agent that causes water to be retained in the colon. The electrolyte solution prevents significant shifts in fluid and electrolytes. The large volume of unabsorbed fluid distends the colon, inducing rapid and thorough evacuation.
Pharmacokinetics
Absorption:
Bioavailability:
<1%
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Should be administered on an empty stomach or after a light breakfast.
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:
>99%
Pharmacodynamics
OnsetOfAction:
Within 1 hour (first bowel movement)
PeakEffect:
Continuous bowel evacuation during administration
DurationOfAction:
Continues until solution is consumed and bowel is clear (typically 4-6 hours)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Stomach pain
Anal irritation
Bloating
Feeling full
Nausea or vomiting
Stomach cramps
Sleep disturbances
Increased appetite
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 medical attention 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 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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Stomach pain
Anal irritation
Bloating
Feeling full
Nausea or vomiting
Stomach cramps
Sleep disturbances
Increased appetite
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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
- Bloating that doesn't go away
- Vomiting that prevents you from taking the solution
- Signs of dehydration (e.g., extreme thirst, dizziness, lightheadedness, decreased urination)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Irregular heartbeat or chest pain
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 problems 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 overall health and any existing medical conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 problems 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 overall health and any existing medical conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 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 of age, exercise caution when using this drug, as you may be more susceptible to side effects.
Although some medications can be used in children, caution is advised when administering this drug to a child. 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 breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Unless directed by your doctor, do not use 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 of age, exercise caution when using this drug, as you may be more susceptible to side effects.
Although some medications can be used in children, caution is advised when administering this drug to a child. 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 breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Significant fluid and electrolyte imbalance (e.g., hypokalemia, hyponatremia)
- Dehydration
- Metabolic acidosis or alkalosis
- Seizures (rare)
What to Do:
Discontinue the medication. Provide supportive care, including fluid and electrolyte replacement as needed. Monitor vital signs and laboratory parameters. Call 911 or Poison Control (1-800-222-1222).
Drug Interactions
Major Interactions
- Oral medications taken within 1 hour of starting or during PEG-ELS administration (may be flushed out of the GI tract and not absorbed)
Moderate Interactions
- Diuretics (increased risk of electrolyte imbalance, especially in patients with impaired renal function)
- ACE inhibitors (increased risk of electrolyte imbalance, especially in patients with impaired renal function)
- NSAIDs (increased risk of electrolyte imbalance, especially in patients with impaired renal function)
- Laxatives (additive effect, increased risk of dehydration and electrolyte imbalance)
Monitoring
Baseline Monitoring
Electrolytes (Sodium, Potassium, Chloride, Bicarbonate)
Rationale: To establish baseline levels, especially in patients at risk for electrolyte disturbances (e.g., renal impairment, heart failure, concomitant medications).
Timing: Prior to administration, if clinically indicated.
Renal Function (BUN, Creatinine)
Rationale: To assess kidney function, particularly in elderly or renally impaired patients, as fluid and electrolyte shifts can exacerbate renal issues.
Timing: Prior to administration, if clinically indicated.
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, persistent dark urine, decreased urine output
Electrolytes
Frequency: Post-procedure, if clinically indicated (e.g., symptoms of imbalance, high-risk patients)
Target: Within normal limits
Action Threshold: Significant deviations from baseline or normal range, symptomatic electrolyte imbalance
Vital Signs (BP, HR)
Frequency: Periodically during administration, if clinically indicated
Target: Within patient's normal range
Action Threshold: Orthostatic hypotension, tachycardia, signs of hypovolemia
Symptom Monitoring
- Signs of dehydration (e.g., thirst, dry mouth, decreased urination, dizziness, lightheadedness)
- Symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, confusion, irregular heartbeat, seizures)
- Severe abdominal pain, bloating, distension
- Nausea, vomiting
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Generally considered low risk due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk, but caution advised.
Second Trimester:
Low risk.
Third Trimester:
Low risk, but caution with dehydration in late pregnancy.
Lactation
Considered safe for use during breastfeeding due to minimal systemic absorption by the mother and negligible excretion into breast milk.
Infant Risk:
Low risk
Pediatric Use
Used in pediatric patients for bowel preparation, but requires careful monitoring of fluid and electrolyte status, especially in younger children or those with underlying conditions. Dosing is weight-based.
Geriatric Use
Use with caution in elderly patients, who may be more susceptible to fluid and electrolyte disturbances, dehydration, and orthostatic hypotension. Ensure adequate hydration and monitor closely, especially if comorbidities (e.g., renal impairment, heart failure) are present.
Clinical Information
Clinical Pearls
- Chill the solution before administration to improve palatability.
- Use a straw to drink the solution, as it can help bypass taste buds.
- Consider adding a clear, sugar-free flavoring packet (if not already flavored) to improve taste, but avoid red or purple flavors.
- Encourage patients to drink the solution at the prescribed rate, even if they feel full or nauseated, to ensure adequate cleansing.
- Advise patients to apply petroleum jelly or a barrier cream to the perianal area to prevent skin irritation from frequent bowel movements.
- Ensure patients understand the importance of completing the entire prescribed volume for effective bowel preparation.
- For split-dose regimens, emphasize the importance of waking up early to complete the second half of the preparation several hours before the procedure.
Alternative Therapies
- Sodium picosulfate, magnesium oxide, and anhydrous citric acid (e.g., Prepopik, Clenpiq)
- Sodium phosphate products (e.g., OsmoPrep, Visicol - use with caution due to renal risk)
- Magnesium citrate
- Oral sodium sulfate, magnesium sulfate, and potassium sulfate (e.g., Suprep)
Cost & Coverage
Average Cost:
$30 - $100 per 4L kit
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, typically Tier 2 or 3, especially for colonoscopy preparation.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. 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 information will help healthcare professionals provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. 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 information will help healthcare professionals provide you with the most appropriate care and treatment.