Polyeth Glycol 3350 Nf Pow Pack

Manufacturer MYLAN Active Ingredient Polyethylene Glycol-3350 Powder Packets for Oral Solution(pol i ETH i leen GLYE kol 3350) Pronunciation pol-i-ETH-i-leen GLYE-kol three-three-five-zero
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
Category B
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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 laxative that helps relieve occasional constipation. It works by drawing water into your stool, making it softer and 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 Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. 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 consuming. Do not drink the mixture if you notice any clumps. Additionally, avoid mixing the powder with starch-based thickeners.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding bathrooms and areas where children and pets may access it. Keep all medications in a secure place and out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal methods, which may include drug take-back programs in your area.

Managing Missed Doses

If you take this medication on a regular schedule, take a missed dose as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your normal 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

  • Increase daily fluid intake (e.g., water, clear broths) to help the medication work effectively and prevent dehydration.
  • Incorporate fiber-rich foods into your diet (e.g., fruits, vegetables, whole grains) to promote regular bowel movements.
  • Engage in regular physical activity, as exercise can help stimulate 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 packet) 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: 17 grams once daily
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Pediatric Dosing

Neonatal: Not established for this packet form. Use in neonates is off-label and requires individualized dosing by a healthcare professional.
Infant: Not established for this packet form. Use in infants is off-label and requires individualized dosing by a healthcare professional.
Child: Not established for routine use in children under 17 years for this packet form. Off-label use for chronic constipation typically ranges from 0.2 to 0.8 g/kg/day, adjusted based on response.
Adolescent: For adolescents 17 years of age and older, the adult dose of 17 grams once daily is typically used.
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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 inert, non-absorbable, osmotically active polymer. It works by retaining water in the bowel lumen, which softens the stool and increases stool bulk. This increased bulk stimulates peristalsis, promoting bowel movements.
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Pharmacokinetics

Absorption:

Bioavailability: < 0.1%
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: None reported to be clinically 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 (continuous effect with daily dosing)
DurationOfAction: As long as taken

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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:

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 do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

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, cramping, or bloating that worsens
  • Rectal bleeding or blood in stools
  • Nausea or vomiting that persists
  • Diarrhea that is severe or persistent
  • Signs of dehydration (e.g., extreme thirst, decreased urination, dizziness, lightheadedness)
  • No bowel movement after 7 days of use (consult a doctor)
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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 (IBS)
Kidney disease or any kidney problems

This list is not exhaustive, and it is crucial to discuss all your health conditions with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements
* Vitamins

It is vital to verify that it is safe 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.
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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 complications, do not use this drug for more than 7 days without explicit instructions from your doctor. Additionally, refrain from using other laxatives or stool softeners unless your doctor advises you to do so. You may not experience the full effects of this medication 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 abdominal cramping
  • Nausea
  • Vomiting
  • Dehydration
  • Electrolyte imbalances (e.g., low potassium, low sodium)

What to Do:

Discontinue use. Rehydrate with fluids and electrolytes. Seek immediate medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Minor Interactions

  • Oral medications (potential for decreased absorption if taken simultaneously; separate administration by at least 2 hours)

Monitoring

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Baseline Monitoring

Bowel habits and frequency

Rationale: To establish baseline and assess treatment efficacy.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate fluid intake and prevent dehydration, especially in elderly or debilitated patients.

Timing: Prior to initiation of therapy

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Routine Monitoring

Bowel movements (frequency, consistency)

Frequency: Daily

Target: Regular, soft, formed stools

Action Threshold: If no bowel movement after 3 days, or if diarrhea/abdominal pain occurs, reassess treatment.

Hydration status

Frequency: Daily

Target: Adequate fluid intake, no signs of dehydration

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

Electrolyte levels (Na, K, Cl, HCO3)

Frequency: As clinically indicated (e.g., prolonged use, high doses, or in patients with pre-existing renal/cardiac conditions or on diuretics)

Target: Within normal limits

Action Threshold: If abnormalities detected, especially in symptomatic patients.

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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
  • Worsening constipation

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy due to minimal systemic absorption. Consult a healthcare provider before use.

Trimester-Specific Risks:

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

Considered safe for use during breastfeeding due to minimal systemic absorption by the mother, making infant exposure unlikely. Consult a healthcare provider before use.

Infant Risk: Low risk
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Pediatric Use

Not recommended for routine use in children under 17 years of age for this packet form without medical supervision. Off-label use for chronic constipation in younger children is common but requires individualized dosing and monitoring by a healthcare professional.

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Geriatric Use

Generally safe and well-tolerated in elderly patients. No specific dose adjustment is typically required. Ensure adequate fluid intake to prevent dehydration, especially in frail or debilitated individuals.

Clinical Information

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Clinical Pearls

  • Polyethylene Glycol 3350 is an osmotic laxative, not a stimulant laxative, and generally does not cause cramping or urgency.
  • It is important to mix the powder completely in 4 to 8 ounces of liquid (water, juice, soda, coffee, or tea) before drinking.
  • Onset of action is typically 1 to 3 days, so it is not suitable for immediate constipation relief.
  • Can be used for long-term management of chronic constipation under medical supervision.
  • Adequate fluid intake is crucial for the effectiveness of PEG 3350 and to prevent dehydration.
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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
  • Lubricant laxatives (e.g., mineral oil)
  • Guanylate cyclase-C agonists (e.g., linaclotide, plecanatide) for chronic idiopathic constipation
  • Chloride channel activators (e.g., lubiprostone) for chronic idiopathic constipation
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Cost & Coverage

Average Cost: $15 - $30 per 30 packets
Generic Available: Yes
Insurance Coverage: Often available over-the-counter (OTC); may be covered by some prescription drug plans with a prescription.
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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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.