Polyeth Glyc 3350 Nf Pwdr Pks

Manufacturer ANI PHARMACEUTICALS 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-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?

Polyethylene Glycol 3350 is a type of laxative that helps you have a bowel movement by drawing water into your intestines. This softens your stool and makes it easier to pass. It's commonly used to treat occasional constipation.
📋

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 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. It's essential to check that there are no clumps in the mixture before consumption. Avoid mixing the powder with starch-based thickeners.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, 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. Instead, consult your pharmacist for guidance on the best disposal method or inquire about potential 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's close to the time for your next 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.
💡

Lifestyle & Tips

  • Increase fluid intake (especially water) while taking this medication.
  • Increase dietary fiber intake (fruits, vegetables, whole grains) to help prevent future 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 g (one packet) dissolved in 4 to 8 ounces of water or other beverage once daily
Dose Range: 17 - 34 mg

Condition-Specific Dosing:

chronicConstipation: 17 g once daily for up to 2 weeks, or as directed by physician. May be used for longer periods under medical supervision.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established (use under medical supervision only, dose typically 0.2-0.8 g/kg/day)
Child: Not established for OTC use (typically 0.2-0.8 g/kg/day, max 17g/day, under medical supervision)
Adolescent: 17 g once daily (for ages 17 and older, same as adult dose for OTC use)
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Polyethylene Glycol 3350 is an osmotic agent that causes water to be retained in the stool. It works by drawing water into the colon, which softens the stool and increases stool bulk, thereby stimulating bowel movements. It is an inert, non-absorbable, osmotically active polymer.
📊

Pharmacokinetics

Absorption:

Bioavailability: < 0.2%
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not 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: Primarily excreted unchanged in feces
Unchanged: > 99%
âąī¸

Pharmacodynamics

OnsetOfAction: 24 to 72 hours (1 to 3 days)
PeakEffect: Not applicable (gradual effect)
DurationOfAction: As long as treatment 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. 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
  • Nausea or vomiting
  • Rectal bleeding
  • No bowel movement after 3 days of use
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of electrolyte imbalance (unusual muscle weakness, cramps, irregular heartbeat, excessive thirst, confusion)
📋

Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Bowel obstruction or blockage
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that last longer than 2 weeks
+ Irritable bowel syndrome
+ Kidney disease
It is crucial to note that this list is not exhaustive, and you should discuss all your health problems with your doctor.

Additionally, inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
* 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 change the dose of any medication without consulting your doctor first.
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 risks, 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 become fully effective. If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial 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.
🆘

Overdose Information

Overdose Symptoms:

  • Severe diarrhea
  • Excessive fluid loss
  • Electrolyte imbalances (e.g., hypokalemia, hyponatremia)
  • Abdominal pain
  • Nausea
  • Vomiting

What to Do:

Discontinue use. Provide supportive care, including fluid and electrolyte replacement as needed. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

Drug Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Bowel habits and history of constipation

Rationale: To establish baseline and assess effectiveness

Timing: Prior to initiation

Electrolytes (Na, K, Cl, HCO3)

Rationale: To assess baseline electrolyte status, especially in patients at risk for imbalance (e.g., renal impairment, heart failure, concomitant diuretic use)

Timing: Prior to initiation, if clinically indicated

📊

Routine Monitoring

Bowel movements (frequency, consistency)

Frequency: Daily

Target: Regular, soft, formed stools

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

Abdominal discomfort/bloating

Frequency: Daily

Target: Minimal to none

Action Threshold: Severe or persistent abdominal pain, bloating, or cramping

Electrolytes (Na, K, Cl, HCO3)

Frequency: Periodically, if prolonged use or risk factors for imbalance

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, excessive thirst, confusion)

Special Patient Groups

🤰

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
Second Trimester: Low risk
Third Trimester: Low risk
🤱

Lactation

Considered compatible with breastfeeding due to minimal systemic absorption by the mother and negligible excretion into breast milk. Consult a healthcare provider before use.

Infant Risk: L1 (Safest)
đŸ‘ļ

Pediatric Use

Not recommended for routine OTC use in children under 17 years of age without medical supervision. Dosing for children should be determined by a healthcare professional based on weight and age, typically for chronic constipation or bowel preparation. Risk of electrolyte imbalance may be higher in very young children.

👴

Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustment is typically required. However, elderly patients may be more susceptible to electrolyte imbalances, especially if they have pre-existing renal impairment or are on diuretics. Monitor for signs of dehydration or electrolyte disturbance.

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 tasteless and dissolves easily in various beverages, making it palatable for most patients.
  • Patients should be advised that it may take 1-3 days to produce a bowel movement.
  • Adequate fluid intake is crucial for its effectiveness and to prevent dehydration.
  • Long-term use is generally safe under medical supervision, unlike stimulant laxatives which can lead to dependence.
  • Ensure patients understand the difference between PEG 3350 (osmotic laxative) and stimulant laxatives to avoid misuse.
🔄

Alternative Therapies

  • Fiber supplements (e.g., psyllium, methylcellulose)
  • Stool softeners (e.g., docusate sodium)
  • Other osmotic laxatives (e.g., lactulose, magnesium hydroxide, magnesium citrate)
  • 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., methylnaltrexone, naloxegol) - for opioid-induced constipation
💰

Cost & Coverage

Average Cost: $15 - $40 per 14-30 packets
Generic Available: Yes
Insurance Coverage: Often covered by prescription plans, may be OTC benefit eligible for some plans. Generic versions are typically Tier 1 or 2.
📚

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 your medication, don't hesitate to discuss them 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.