Polyethylene glycol

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Polyethylene glycol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Polyethylene glycol is a Laxative that is FDA approved for the treatment of constipation. Common adverse reactions include Diarrhea, Flatulence, Nausea, Stomach cramps.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

Directions

  • do not take more than directed unless advised by your doctor
  • the enclosed scoop is a measuring device designed to contain 17 grams of powder when filled to the top (level scoop)
  • adults and children 17 years of age and older:
  • fill scoop completely with product to obtain the correct dose (17 g). Level scoop with knife or flat object.
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • use once a day
  • use no more than 7 days
  • children 16 years of age or under: ask a doctor

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polyethylene glycol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Polyethylene glycol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety and effectiveness not established in children

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Polyethylene glycol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Polyethylene glycol in pediatric patients.

Contraindications

There is limited information regarding Polyethylene glycol Contraindications in the drug label.

Warnings

  • Allergy alert: Do not use if you are allergic to polyethylene glycol
  • Do not use
  • if you have kidney disease, except under the advice and supervision of a doctor
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • taking a prescription drug
  • When using this product
  • you may have loose, watery, more frequent stools
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • ask a health professional before use.
  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Polyethylene glycol in the drug label.

Postmarketing Experience

Drug Interactions

There is limited information regarding Polyethylene glycol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • If pregnant or breast-feeding,

ask a health professional before use.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Polyethylene glycol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Polyethylene glycol during labor and delivery.

Nursing Mothers

If pregnant or breast-feeding, ask a health professional before use.

Pediatric Use

safety and effectiveness not established in children

Geriatic Use

There is no FDA guidance on the use of Polyethylene glycol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Polyethylene glycol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Polyethylene glycol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Polyethylene glycol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Polyethylene glycol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Polyethylene glycol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Polyethylene glycol in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Polyethylene glycol in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Polyethylene glycol in the drug label.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Pharmacology

Template:Chembox E number
Polyethylene glycol
IUPAC name poly(oxyethylene) {structure-based},
poly(ethylene oxide) {source-based}[1]
Other names Carbowax, GoLYTELY, GlycoLax, Fortrans, TriLyte, Colyte, Halflytely, Macrogol, MiraLAX, MoviPrep
Identifiers
ChEMBL
ChemSpider
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UNII
Properties
C2nH4n+2On+1
Molar mass variable
Hazards
Flash point {{{value}}}
Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)

Infobox disclaimer and references

Mechanism of Action

Structure

  • ACTIVE INGREDIENT (IN EACH DOSE)

Polyethylene Glycol 3350, 17 g (in each level scoop)

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Polyethylene glycol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Polyethylene glycol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Polyethylene glycol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Polyethylene glycol in the drug label.

How Supplied

Storage

  • store at 20°-25°C (68°-77°F)
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Images

Drug Images

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

Patient Counseling Information

QUESTIONS OR COMMENTS? 1-800-719-9260

Precautions with Alcohol

  • Alcohol-Polyethylene glycol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is no information regarding look alike drug names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. J. Kahovec, R. B. Fox and K. Hatada (2002). "Nomenclature of regular single-strand organic polymers". Pure and Applied Chemistry. 74 (10): 1921–1956. doi:10.1351/pac200274101921.
  2. "Polyethylene glycol".

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