Polyethylene glycol: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{RB}} | |||
|OTC=Yes | |||
|genericName=Polyethylene glycol | |||
|aOrAn=a | |aOrAn=a | ||
|drugClass=Laxative | |||
|indicationType=treatment | |indicationType=treatment | ||
| | |indication=constipation | ||
|adverseReactions=<!--Black Box Warning--> | |adverseReactions= Diarrhea, Flatulence, Nausea, Stomach cramps | ||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
Line 12: | Line 18: | ||
<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult====== | |fdaLIADAdult=====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 | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
: | |||
= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport= | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Pediatric Indications and Dosage--> | <!--Pediatric Indications and Dosage--> | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed= | |fdaLIADPed=safety and effectiveness not established in children | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport= | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
* | <!--Contraindications--> | ||
|contraindications=* Condition1 | |||
: | <!--Warnings--> | ||
|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--> | <!--Adverse Reactions--> | ||
Line 189: | Line 144: | ||
<!--Postmarketing Experience--> | <!--Postmarketing Experience--> | ||
|postmarketing= | |postmarketing=Diarrhea, Flatulence, Nausea, Stomach cramps | ||
|drugInteractions=* Drug | |drugInteractions=* Drug | ||
:* Description | :* Description | ||
<!--Use in Specific Populations--> | <!--Use in Specific Populations--> | ||
|useInPregnancyFDA=* | |useInPregnancyFDA=* If pregnant or breast-feeding, | ||
ask a health professional before use. | |||
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | ||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
| | |useInNursing=If pregnant or breast-feeding, | ||
ask a health professional before use. | |||
|useInPed= | |useInPed=safety and effectiveness not established in children | ||
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | ||
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | ||
Line 266: | Line 168: | ||
|administration=* Oral | |administration=* Oral | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
<!--IV Compatibility--> | <!--IV Compatibility--> | ||
Line 275: | Line 177: | ||
<!--Overdosage--> | <!--Overdosage--> | ||
|overdose= | |overdose=In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) | ||
|drugBox=<!--Mechanism of Action--> | |drugBox=<!--Mechanism of Action--> | ||
|mechAction=* | |mechAction=* |
Revision as of 19:19, 24 April 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
Disclaimer
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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
- 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
- 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
There is limited information regarding Polyethylene glycol Pharmacology in the drug label.
Mechanism of Action
Structure
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
There is limited information regarding Polyethylene glycol Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Polyethylene glycol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Polyethylene glycol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Polyethylene glycol in the drug label.
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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
|title=
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