Polyeth Glycol 3350 Nf Powder 238gm

Manufacturer PERRIGO 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
Not available
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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 an osmotic laxative used to treat occasional constipation. It works by bringing water into your intestines, which helps soften your stool and makes it easier to pass. It does not cause immediate bowel movements but typically works within 1 to 3 days.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. When preparing your dose, 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 your medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, 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.

Missing a Dose

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, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids (at least 6-8 glasses of water daily) while taking this medication to help it work effectively and prevent dehydration.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) to help prevent future constipation.
  • Engage in regular physical activity to promote healthy bowel function.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 17 grams (one heaping 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:

chronicConstipation: May be used daily for up to 7 days; consult physician for longer use.
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Pediatric Dosing

Neonatal: Not established (use under strict medical supervision for specific conditions like meconium ileus equivalent).
Infant: Not established for general use. For chronic constipation, often 0.2-0.8 g/kg/day, divided, under medical supervision.
Child: For children 2 to 16 years: 0.4 g/kg/day (max 17g/day) for chronic constipation, under medical supervision. For occasional constipation, consult a physician.
Adolescent: For adolescents 17 years and older: Same as adult dosing (17 grams once daily).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.
Dialysis: No adjustment needed due to 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 osmotic agent that causes water to be retained with the stool. It works by drawing water into the colon, which softens the stool and increases bowel movement frequency. It is a non-absorbable, inert polymer that acts locally in the gastrointestinal tract.
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Pharmacokinetics

Absorption:

Bioavailability: <0.2%
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: None significant

Distribution:

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

Elimination:

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

OnsetOfAction: 1 to 3 days
PeakEffect: Not applicable (gradual effect)
DurationOfAction: Variable, depends on continued use and individual bowel habits

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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, or 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Loose, watery, or more frequent stools
- Stomach pain or cramps
- Gas
- Bloating
- Upset stomach

Reporting Side Effects
This list does not include all 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, cramping, or bloating
  • Nausea or vomiting
  • Rectal bleeding
  • No bowel movement after 3 days of use
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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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 interact with 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 breastfeeding, be sure to discuss this 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, low sodium)
  • Abdominal cramping
  • Nausea
  • Vomiting

What to Do:

Discontinue use immediately. Seek medical attention. Management is supportive, focusing on fluid and electrolyte replacement. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Moderate Interactions

  • Other laxatives (may increase risk of diarrhea and electrolyte imbalance if used concomitantly)

Monitoring

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Baseline Monitoring

Assessment of constipation severity and duration

Rationale: To determine appropriate treatment duration and rule out underlying conditions.

Timing: Prior to initiation of therapy

Rule out bowel obstruction

Rationale: Laxatives are contraindicated in cases of suspected bowel obstruction.

Timing: Prior to initiation of therapy

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Routine Monitoring

Frequency and consistency of bowel movements

Frequency: Daily

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 3 days of use, or persistent diarrhea/abdominal pain

Hydration status

Frequency: Daily

Target: Adequate fluid intake

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

Electrolytes (e.g., sodium, potassium)

Frequency: Only if prolonged use (>7 days), high doses, or in patients with renal/cardiac impairment or concomitant diuretic use

Target: Within normal limits

Action Threshold: Abnormal electrolyte levels, especially hypokalemia or hyponatremia

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Symptom Monitoring

  • Abdominal pain
  • Bloating
  • Nausea
  • Diarrhea
  • Rectal bleeding
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Polyethylene Glycol 3350 is generally considered safe for use during pregnancy due to its minimal systemic absorption. It is not formally assigned an FDA pregnancy category, but clinical experience and data suggest a low risk of fetal harm.

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

Polyethylene Glycol 3350 is considered safe for use during breastfeeding. Due to its very low systemic absorption, it is unlikely to be excreted into breast milk in clinically significant amounts or cause adverse effects in the breastfed infant.

Infant Risk: Low risk (L1 - safest category).
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Pediatric Use

Use in children, especially those under 17 years, should be under the guidance of a healthcare professional. Dosing is often weight-based for chronic constipation. Ensure adequate fluid intake to prevent dehydration.

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Geriatric Use

Generally safe for use in elderly patients. Monitor for adequate hydration and potential electrolyte imbalances, especially with prolonged use or in those with pre-existing renal or cardiac conditions. Start with the lowest effective dose.

Clinical Information

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Clinical Pearls

  • PEG 3350 is a first-line osmotic laxative for chronic constipation due to its efficacy and good tolerability profile.
  • It is important to emphasize that PEG 3350 does not produce an immediate bowel movement; effects typically begin within 1-3 days.
  • Advise patients to mix the powder thoroughly in at least 4-8 ounces of liquid until fully dissolved.
  • Encourage adequate fluid intake throughout the day to maximize efficacy and prevent dehydration.
  • While generally safe for long-term use under medical supervision, patients should be advised not to self-treat for more than 7 days without consulting a healthcare provider.
  • Unlike stimulant laxatives, PEG 3350 is not associated with tolerance or 'lazy bowel' syndrome.
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Alternative Therapies

  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Stool softeners (e.g., docusate sodium)
  • Stimulant laxatives (e.g., bisacodyl, senna)
  • Saline laxatives (e.g., magnesium hydroxide, magnesium citrate)
  • Lubricant laxatives (e.g., mineral oil)
  • Chloride channel activators (e.g., lubiprostone)
  • Guanylate cyclase-C agonists (e.g., linaclotide, plecanatide)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$30 per 238g bottle
Generic Available: Yes
Insurance Coverage: Often covered by prescription plans as a generic, may be OTC for some plans. Varies by insurance formulary.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.