Polyethylene glycol

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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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

• Condition1

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 nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome 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 you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week 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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

Diarrhea, Flatulence, Nausea, Stomach cramps

Drug Interactions

• Drug

• Description

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

• Oral

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

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Template:Chembox header2 | Polyethylene glycol
Identifiers
CAS Number	25322-68-3 Y
ChEMBL	ChEMBL1201478 N
ChemSpider	NA Y
ECHA InfoCard
UNII	3WJQ0SDW1A N
Properties
Chemical formula	C2nH4n+2On+1
Molar mass	variable
Hazards
Template:Chembox header2 | 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

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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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

• CLEAR LAX®

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.

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