Polyeth Glyc 3350 Nf Pwdr Packs

Manufacturer PERRIGO /PADAGIS PHARMA Active Ingredient Polyethylene Glycol-3350 Powder Packets for Oral Solution(pol i ETH i leen GLYE kol 3350) Pronunciation pol-ee-ETH-i-leen GLYE-kol three-three-five-zero
It is used to treat constipation.
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Drug Class
Laxative, Osmotic
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Pharmacologic Class
Osmotic agent
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Pregnancy Category
Not assigned (OTC), generally considered low risk due to minimal systemic absorption
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Polyethylene Glycol 3350 is an over-the-counter laxative used to treat occasional constipation. It works by drawing water into your stool, making it softer and easier to pass. It does not cause immediate bowel movements and may take 1 to 3 days to produce a full effect.
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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 with your medication and follow the instructions closely. When taking your 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. It's essential to check that there are no clumps in the liquid before consuming it. Avoid mixing your medication with starch-based thickeners.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the 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 the best disposal method or explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you take your medication on a regular schedule, take the missed dose as soon as you remember. However, 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 take extra doses. If you take your medication as needed, be sure not to take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Increase fluid intake throughout the day to help the medication work effectively and prevent dehydration.
  • Include fiber-rich foods in your diet (fruits, vegetables, whole grains) to support regular bowel movements.
  • Engage in regular physical activity, which 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) dissolved in 4 to 8 ounces of water or other beverage 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 specific OTC product; consult physician
Infant: Not established for this specific OTC product; consult physician
Child: Not established for this specific OTC product; consult physician (often used off-label at 0.2-0.8 g/kg/day for chronic constipation)
Adolescent: Not established for this specific OTC product; consult physician (often adult dose for >17 years old)
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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 causing water to be retained within the bowel lumen, which softens the stool, increases stool bulk, and stimulates peristalsis, leading to a bowel movement.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (<0.1%)
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: Nearly 100% (of absorbed portion, which is negligible)
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Pharmacodynamics

OnsetOfAction: 1 to 3 days for full effect
PeakEffect: Not applicable (gradual effect)
DurationOfAction: Effect persists 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. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 unusual 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, cramping, or bloating
  • Persistent or worsening diarrhea
  • Rectal bleeding
  • Nausea or vomiting
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • No bowel movement after 3 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 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 complications, do not use this drug for more than 1 week 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
  • Dehydration
  • Electrolyte imbalance (e.g., low sodium, low potassium)

What to Do:

Discontinue use immediately. Seek medical attention. Management is supportive, including rehydration with fluids and correction of electrolyte imbalances if necessary. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Moderate Interactions

  • Other oral medications (potential for reduced absorption if taken simultaneously)

Monitoring

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Baseline Monitoring

Bowel habits

Rationale: To establish baseline and assess constipation severity

Timing: Prior to initiation

Hydration status

Rationale: To ensure adequate fluid intake and prevent dehydration

Timing: Prior to initiation

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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, persistent diarrhea, or worsening constipation

Abdominal discomfort/bloating

Frequency: Daily

Target: Minimal to none

Action Threshold: Severe or persistent abdominal pain/bloating

Signs of dehydration (e.g., thirst, dry mouth)

Frequency: Daily

Target: Well-hydrated

Action Threshold: Signs of dehydration, especially with excessive diarrhea

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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

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

Trimester-Specific Risks:

First Trimester: Low risk
Second Trimester: Low risk
Third Trimester: Low risk
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Lactation

Considered compatible with breastfeeding due to minimal systemic absorption by the mother, meaning negligible amounts are expected to pass into breast milk. Consult a healthcare provider.

Infant Risk: Low risk
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Pediatric Use

Not indicated for children under 17 years old for this specific OTC product unless directed by a physician. Pediatric use for chronic constipation is common off-label under medical supervision, with doses adjusted by weight and age.

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Geriatric Use

Generally safe for use in geriatric patients. No dose adjustment is typically needed. Ensure adequate hydration to prevent dehydration, which older adults may be more susceptible to.

Clinical Information

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Clinical Pearls

  • Polyethylene Glycol 3350 is a gentle, effective osmotic laxative that does not cause dependency like stimulant laxatives.
  • It is often preferred for chronic constipation due to its safety profile and lack of significant systemic effects.
  • Patients should be advised that it is not for immediate relief and may take 1-3 days to produce a bowel movement.
  • Ensure patients mix the powder completely in the recommended amount of liquid (water, juice, soda, coffee, tea) before consumption.
  • Adequate fluid intake is crucial for the medication to work effectively and to prevent dehydration.
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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) - for short-term use only
  • Saline laxatives (e.g., magnesium hydroxide, magnesium citrate) - for acute use
  • Lubricant laxatives (e.g., mineral oil)
  • Dietary fiber supplementation
  • Increased fluid intake
  • Regular exercise
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Cost & Coverage

Average Cost: $10 - $30 per 10-30 packets/doses
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as an over-the-counter (OTC) medication, but may be eligible for FSA/HSA reimbursement.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.