PEG 3350 Powder 850gm

Manufacturer RUGBY LABORATORIES 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.
đŸˇī¸
Drug Class
Laxative
đŸ§Ŧ
Pharmacologic Class
Osmotic Laxative
🤰
Pregnancy Category
Category C
✅
FDA Approved
Feb 1999
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

PEG 3350 is a powder that you mix with liquid and drink. It works by bringing water into your intestines to soften your stool and make it easier to have a bowel movement. It's commonly used to treat occasional constipation.
📋

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 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 the bathroom. Keep all medications in a secure 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.

Managing Missed Doses

If you take this medication on a regular schedule, take a 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 normal 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.
💡

Lifestyle & Tips

  • Drink plenty of fluids throughout the day to help the medication work effectively and prevent dehydration.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) as tolerated, but do not rely solely on fiber for severe constipation.
  • Engage in regular physical activity to promote bowel regularity.
  • Do not use for more than 7 days unless directed by a doctor.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 17 grams (one heaping tablespoon) of powder dissolved in 4 to 8 ounces of water, juice, soda, coffee, or tea once daily.
Dose Range: 17 - 34 mg

Condition-Specific Dosing:

chronic_constipation: 17 grams once daily for up to 7 days. For longer use, consult a healthcare professional.
bowel_preparation: Higher doses (e.g., 238 grams or 255 grams) mixed with electrolytes for colonoscopy preparation, as directed by physician.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (off-label use may occur under strict medical supervision for specific conditions).
Infant: Not FDA approved for routine use. Off-label dosing varies, typically 0.2-0.8 g/kg/day, adjusted to effect. Consult pediatrician.
Child: Not FDA approved for routine use. Off-label dosing varies, typically 0.2-0.8 g/kg/day, adjusted to effect. Max 17g/day. Consult pediatrician.
Adolescent: Not FDA approved for routine use. Off-label dosing typically 17 grams once daily. Consult pediatrician.
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Polyethylene Glycol 3350 is an osmotic laxative. It is an inert, non-absorbable, osmotically active polymer that causes water to be retained within the bowel lumen. This increases the water content of the stool, leading to increased stool bulk, softened stool consistency, and increased stool frequency.
📊

Pharmacokinetics

Absorption:

Bioavailability: Less than 0.2%
Tmax: Not applicable (minimally absorbed)
FoodEffect: No significant food effect, can be taken with or without food.

Distribution:

Vd: Not applicable (minimally absorbed)
ProteinBinding: Not applicable (minimally absorbed)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimally absorbed)
Clearance: Not applicable (minimally absorbed)
ExcretionRoute: Primarily excreted unchanged in feces.
Unchanged: Greater than 99.8%
âąī¸

Pharmacodynamics

OnsetOfAction: 24 to 96 hours (1 to 4 days)
PeakEffect: Not well-defined, gradual effect over several days.
DurationOfAction: Maintained as long as therapy continues.

Safety & Warnings

âš ī¸

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 unusual symptoms that bother you or persist, contact your doctor for guidance:

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 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, cramping, or bloating that worsens.
  • Rectal bleeding or blood in your stool.
  • Nausea or vomiting that does not go away.
  • No bowel movement after 7 days of use.
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Signs of electrolyte imbalance (e.g., unusual muscle weakness, cramps, irregular heartbeat, extreme thirst, confusion).
📋

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.
âš ī¸

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 a period exceeding 1 week unless explicitly instructed to do so by your doctor. Additionally, refrain from using other laxatives or stool softeners without first consulting your doctor. Please note that it may take several days to experience the full therapeutic effect of this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial to discuss your situation with your doctor, as this will enable you to have a thorough understanding of the benefits and risks associated with this medication for both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Severe diarrhea
  • Excessive fluid loss
  • Electrolyte imbalances (e.g., hypokalemia, hyponatremia, metabolic acidosis/alkalosis)
  • 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 suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222).

Drug Interactions

🟡

Moderate Interactions

  • Diuretics (potential for electrolyte imbalance with excessive use)
  • ACE inhibitors (potential for electrolyte imbalance with excessive use)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Bowel habits and history of constipation

Rationale: To establish baseline and assess appropriateness of therapy.

Timing: Prior to initiation of therapy.

Electrolytes (Na, K, Cl, HCO3)

Rationale: Consider for patients with pre-existing electrolyte imbalances, renal impairment, or those on prolonged therapy, especially if experiencing significant diarrhea.

Timing: Prior to initiation for at-risk patients.

📊

Routine Monitoring

Bowel movements (frequency, consistency)

Frequency: Daily

Target: Regular, soft, formed stools

Action Threshold: No bowel movement after 7 days of use, or persistent diarrhea/abdominal pain.

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, as clinically indicated (e.g., weekly to monthly for prolonged use in at-risk patients)

Target: Within normal limits

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

đŸ‘ī¸

Symptom Monitoring

  • Abdominal pain
  • Bloating
  • Nausea
  • Diarrhea
  • Rectal bleeding
  • Signs of electrolyte imbalance (e.g., muscle weakness, cramps, irregular heartbeat, confusion, excessive thirst)

Special Patient Groups

🤰

Pregnancy

Generally considered safe for use during pregnancy due to minimal systemic absorption. However, use only if clearly needed and under medical supervision.

Trimester-Specific Risks:

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

Lactation

Considered safe for use during breastfeeding. Minimal systemic absorption by the mother means negligible excretion into breast milk, posing no significant risk to the infant.

Infant Risk: Very low risk (L1).
đŸ‘ļ

Pediatric Use

Not FDA approved for routine use in children under 17 years of age for chronic constipation, but widely used off-label by pediatricians. Dosing must be individualized and carefully monitored by a healthcare professional due to potential for electrolyte imbalances with inappropriate use. Long-term safety data in children is limited.

👴

Geriatric Use

Generally safe for use in elderly patients. No specific dose adjustment is typically required. However, elderly patients may be more susceptible to fluid and electrolyte imbalances, so monitor hydration status and electrolyte levels, especially with prolonged use or pre-existing conditions.

Clinical Information

💎

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 dissolve the powder completely in the recommended amount of liquid before consumption.
  • Patients should be advised that it may take 1-4 days to produce a bowel movement.
  • Adequate fluid intake is crucial for the effectiveness of PEG 3350 and to prevent dehydration.
  • While generally safe for long-term use under medical supervision, patients should be encouraged to address underlying causes of constipation (e.g., diet, lifestyle).
  • For bowel preparation, specific formulations and higher doses of PEG 3350 with electrolytes are used, not the single-ingredient powder for chronic constipation.
🔄

Alternative Therapies

  • Bulk-forming laxatives (e.g., psyllium, methylcellulose)
  • Stool softeners (e.g., docusate sodium)
  • Stimulant laxatives (e.g., bisacodyl, senna) - typically for short-term use
  • 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)
  • Peripherally acting mu-opioid receptor antagonists (PAMORAs) (e.g., methylnaltrexone, naloxegol) for opioid-induced constipation.
💰

Cost & Coverage

Average Cost: $15 - $40 per 850gm container
Generic Available: Yes
Insurance Coverage: Often covered as a Tier 1 or Tier 2 generic by most insurance plans. Some plans may require prior authorization for chronic use or specific brand names.
📚

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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.