Polyeth Glycol 3350 Nf Powder 510gm

Manufacturer PERRIGO PHARMACEUTICALS Active Ingredient Polyethylene Glycol-3350 Powder for Oral Solution(pol i ETH i leen GLYE kol 3350) Pronunciation pol-ee-ETH-i-leen GLYE-kol three-three-five-oh
It is used to treat constipation.
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Drug Class
Laxative
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Pharmacologic Class
Osmotic Laxative
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Pregnancy Category
B/C (low systemic absorption, often preferred)
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FDA Approved
Feb 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Polyethylene Glycol 3350 is a powder that you mix with liquid and drink to help treat constipation. It works by drawing water into your intestines, which softens your stool and makes it easier to have a bowel movement. It's not a stimulant, so it works gently and usually takes 1 to 3 days to produce a bowel movement.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. When taking this medication, mix the powder with 1/2 to 1 cup (120 to 240 ml) of a liquid, such as water, juice, soda, coffee, or tea. Stir well to ensure the powder is fully dissolved before drinking. Do not consume the mixture if you notice any clumps. Avoid mixing the powder with starch-based thickeners. Use only the dosing cap that comes with the powder to measure your dose accurately.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Managing Missed Doses

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Drink plenty of fluids throughout the day, especially when taking this medication.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) if tolerated.
  • Engage in regular physical activity to promote bowel regularity.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 17 g (one capful) of powder dissolved in 4 to 8 ounces of water, juice, soda, coffee, or tea, once daily.
Dose Range: 17 - 17 mg

Condition-Specific Dosing:

chronic_constipation: 17 g once daily for up to 7 days, or as directed by a healthcare professional for longer periods.
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Pediatric Dosing

Neonatal: Not established (off-label use common, consult specialist)
Infant: Not established (off-label use common, consult specialist; typical starting dose 0.2-0.4 g/kg/day)
Child: Not established (off-label use common, consult specialist; typical starting dose 0.4 g/kg/day, max 17 g/day)
Adolescent: Not established (off-label use common, consult specialist; typical starting dose 0.4 g/kg/day, max 17 g/day)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; minimal systemic absorption

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Polyethylene glycol 3350 is an inert, non-absorbable, osmotically active polymer. It works by retaining water in the bowel lumen, which increases the water content of the stool. This leads to increased stool volume, softening of the stool, and increased stool frequency, facilitating bowel movements.
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Pharmacokinetics

Absorption:

Bioavailability: <0.2%
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not significant

Distribution:

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

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Fecal excretion
ExcretionRoute: Feces
Unchanged: >99%
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Pharmacodynamics

OnsetOfAction: 1 to 3 days
PeakEffect: 1 to 3 days
DurationOfAction: As long as administered

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Severe dizziness or fainting
Diarrhea
Rectal bleeding or rectal pain

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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:

Loose, watery, or more frequent stools
Stomach pain or cramps
Gas
Bloating
* Upset stomach

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain or cramping
  • Persistent diarrhea
  • Rectal bleeding
  • Nausea or vomiting that doesn't go away
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • No bowel movement after 7 days of use
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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 or blockage
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that last longer than 2 weeks
A diagnosis of irritable bowel syndrome
Kidney disease or any other health problems that may affect your ability to take this medication

Additionally, 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

This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 risks, do not use this drug for more than 7 days unless your doctor specifically instructs you to do so. Additionally, refrain from using other laxatives or stool softeners while taking this medication, unless your doctor advises otherwise. You may not experience the full effects of this drug immediately, as it may take a few days to achieve optimal results. If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial to discuss your situation with your doctor, as you will need to carefully weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe diarrhea
  • Excessive fluid loss
  • Electrolyte imbalances (e.g., low potassium, high sodium)
  • Abdominal cramping
  • Nausea
  • Vomiting

What to Do:

Discontinue use. Provide supportive care, including fluid and electrolyte replacement as needed. In case of severe symptoms or accidental overdose, call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Minor Interactions

  • Oral medications (potential for reduced absorption if taken concurrently, though generally not clinically significant due to PEG's minimal systemic effect)

Monitoring

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Baseline Monitoring

Bowel habits (frequency, consistency)

Rationale: To assess baseline constipation severity and monitor treatment efficacy.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate fluid intake, as PEG 3350 works by drawing water into the colon.

Timing: Prior to initiation of therapy

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Routine Monitoring

Bowel movement frequency and consistency

Frequency: Daily or as needed

Target: Regular, soft, formed stools

Action Threshold: Persistent diarrhea, abdominal pain, or continued constipation after 3 days

Hydration status

Frequency: Daily

Target: Adequate fluid intake, no signs of dehydration

Action Threshold: Signs of dehydration (e.g., dry mouth, decreased urination, dizziness)

Electrolytes (Na, K, Cl, HCO3)

Frequency: Periodically, especially with prolonged use, high doses, or in at-risk patients (e.g., renal impairment, diuretic use)

Target: Within normal limits

Action Threshold: Significant deviations from normal range, especially hypokalemia or hypernatremia

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Symptom Monitoring

  • Abdominal pain
  • Bloating
  • Nausea
  • Diarrhea
  • Excessive gas
  • Signs of dehydration (e.g., thirst, dry mouth, decreased urination, dizziness)
  • Rectal bleeding (seek immediate medical attention)

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy due to minimal systemic absorption. Often a preferred laxative choice for pregnant women with constipation.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Considered safe for use during breastfeeding (L1) due to minimal systemic absorption by the mother, meaning negligible amounts are expected to pass into breast milk.

Infant Risk: Low risk
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Pediatric Use

Widely used off-label for chronic constipation in children, often preferred over stimulant laxatives. Dosing is typically weight-based and should be determined by a healthcare professional. Close monitoring for electrolyte imbalances is recommended, especially in younger children or with prolonged use.

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Geriatric Use

Generally safe and well-tolerated in older adults. However, monitor closely for signs of dehydration or electrolyte imbalances, especially if they have pre-existing renal impairment, cardiac conditions, or are taking diuretics.

Clinical Information

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Clinical Pearls

  • Polyethylene Glycol 3350 is an osmotic laxative, not a stimulant. It works gently and may take 1-3 days to produce a bowel movement.
  • It is important to mix the powder completely in 4-8 ounces of liquid (water, juice, soda, coffee, or tea) before drinking.
  • Adequate fluid intake is crucial for the effectiveness of PEG 3350 and to prevent dehydration.
  • Often considered a first-line treatment for chronic constipation due to its safety profile and lack of tolerance development.
  • Can be used long-term under medical supervision, unlike some stimulant laxatives.
  • Not intended for immediate relief of acute constipation or bowel preparation unless specifically directed by a healthcare professional.
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Alternative Therapies

  • Other osmotic laxatives (e.g., lactulose, magnesium hydroxide, magnesium citrate)
  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Stool softeners (e.g., docusate sodium)
  • Stimulant laxatives (e.g., bisacodyl, senna) - generally for short-term use
  • Chloride channel activators (e.g., lubiprostone)
  • Guanylate cyclase-C agonists (e.g., linaclotide, plecanatide)
  • Peripherally acting mu-opioid receptor antagonists (PAMORAs) (e.g., naloxegol, methylnaltrexone bromide) - for opioid-induced constipation
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Cost & Coverage

Average Cost: $10 - $30 per 510g bottle (approx. 30 doses)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand)
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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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.