Psyllium: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|OTC=Yes
|genericName=psyllium husk
|aOrAn=a
|aOrAn=a
|drugClass=laxative
|indicationType=treatment
|indicationType=treatment
|indication=[[constipation]]
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=borborygmi and flatulence
|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 17:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* For relief of occasional [[constipation]]  and to induce regularity. This product generally produces bowel movement  within 12 to 72 hours


:* Dosage
==Dosage==


=====Condition2=====
* 5 capsules one to three times daily
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


:* Dosage
|offLabelAdultNoGuideSupport===Indications==
* Constipation
* Gastrointestinal symptom, Orlistat-induced
* Hypercholesterolemia


=====Condition3=====


* Dosing Information


:* Dosage
|fdaLIADPed===Indications==


=====Condition4=====
* For relief of occasional constipation  and to induce regularity. This product generally produces bowel movement  within 12 to 72 hours


* Dosing Information
==Dosage==


:* Dosage
'''Children 12 years and over'''
* 5 capsules one to three times daily


<!--Off-Label Use and Dosage (Adult)-->
'''Children under 12 years'''
* Consult a doctor
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Class of Recommendation:


* Strength of Evidence:
|warnings=* '''Choking''' Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.


* Dosing Information
'''DO NOT USE'''


:* Dosage
* When [[abdominal pain]], [[nausea]] or [[vomiting]] are present unless directed by a doctor
* If constipation lasts more than seven days
* If you have difficulty swallowing


=====Condition2=====
'''ASK A DOCTOR BEFORE USE IF YOU HAVE'''


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Noticed a sudden change in bowel habits that persists over a period of 2 weeks.


<!--Non–Guideline-Supported Use (Adult)-->
'''Stop use and ask a doctor if'''
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
* You experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition


:* Dosage


=====Condition2=====
|clinicalTrials=* There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====


* Dosing Information
|useInPregnancyAUS=* There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''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.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
Line 263: Line 86:
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
 
|administration=* Oral
|administration=* Oral


* Intravenous
* Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description


<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
|monitoring=* There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|overdose====Acute Overdose===


====Signs and Symptoms====


* Description


====Management====
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


* Description


===Chronic Overdose===
|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


<!--Drug box 2-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*  
|mechAction=*  


<!--Structure-->
 
|structure=*  
|structure=*  


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
 
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
 
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->
 
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
 
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
 
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>


<!--Look-Alike Drug Names-->
|brandNames=* KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER ®<ref>{{Cite web | title =psyllium husk capsule| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab185f98-fe41-41e5-991d-0ea37dfa5958 }}</ref>
 
 
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->
 
|drugShortage=
|drugShortage=
}}
}}

Revision as of 19:15, 21 April 2015

Psyllium
Black Box Warning
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: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.


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.

Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Psyllium is a laxative that is FDA approved for the treatment of constipation. There is a Black Box Warning for this drug as shown here. Common adverse reactions include borborygmi and flatulence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within 12 to 72 hours

Dosage

  • 5 capsules one to three times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Indications

  • Constipation
  • Gastrointestinal symptom, Orlistat-induced
  • Hypercholesterolemia

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within 12 to 72 hours

Dosage

Children 12 years and over

  • 5 capsules one to three times daily

Children under 12 years

  • Consult a doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Psyllium Contraindications in the drug label.

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

DO NOT USE

  • When abdominal pain, nausea or vomiting are present unless directed by a doctor
  • If constipation lasts more than seven days
  • If you have difficulty swallowing

ASK A DOCTOR BEFORE USE IF YOU HAVE

  • Noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • You experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition

Adverse Reactions

Clinical Trials Experience

  • There is limited information regarding Clinical Trial Experience of Psyllium in the drug label.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Psyllium in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Psyllium in women who are pregnant.
Pregnancy Category (AUS):

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Psyllium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Psyllium with respect to pediatric patients.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

Monitoring

  • There is limited information regarding Monitoring of Psyllium in the drug label.

IV Compatibility

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

Overdosage

  • There is limited information regarding Chronic Overdose of Psyllium in the drug label.

Pharmacology

There is limited information regarding Psyllium Pharmacology in the drug label.

Mechanism of Action

Structure

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Psyllium Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Psyllium |?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::Psyllium |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Psyllium in the drug label.

Precautions with Alcohol

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

Brand Names

  • KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "psyllium husk capsule".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

{{#subobject: 

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}}

{{#subobject: 

 |Label Page=Psyllium
 |Label Name=Psyllium11.png

}}

{{#subobject: 

 |Label Page=Psyllium
 |Label Name=Psyllium11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Psyllium&oldid=1090014"