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


* Dosing Information
* DITROPAN XL® (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.


:* Dosage
* DITROPAN XL® is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., [[spina bifida]]).


=====Condition2=====
==Dosage==


* Dosing Information
* The recommended starting dose of DITROPAN XL® is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.


:* Dosage
==DOSAGE FORMS AND STRENGTHS==


=====Condition3=====
* DITROPAN XL® extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:


* Dosing Information
:*5 mg: Pale yellow, round, tablet with "5 XL" printed on one side with black ink.


:* Dosage
:*10 mg: Pink, round, tablet with "10 XL" printed on one side with black ink.


=====Condition4=====
:*15 mg: Gray, round, tablet with "15 XL" printed on one side with black ink.


* Dosing Information
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


:* Dosage


<!--Off-Label Use and Dosage (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


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


* Developed by:


* Class of Recommendation:
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


* Strength of Evidence:


* Dosing Information


:* Dosage
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


=====Condition2=====


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


<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
|contraindications=* DITROPAN XL® is contraindicated in patients with [[urinary retention]], gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle [[glaucoma]].


:* Dosage
* DITROPAN XL® is also contraindicated in patients who have demonstrated [[hypersensitivity]] to the drug substance or other components of the product. There have been reports of [[hypersensitivity]] reactions, including [[anaphylaxis]] and [[angiodema]].
|warnings='''Angioedema'''


=====Condition2=====
* [[Angioedema]] of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. [[Angioedema]] associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.


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


<!--Pediatric Indications and Dosage-->
* Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including [[hallucinations]], [[agitation]], [[confusion]] and [[somnolence]]. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
* DITROPAN XL® should be used with caution in patients with preexisting [[dementia]] treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
|fdaLIADPed======Condition1=====


* Dosing Information
* DITROPAN XL® should be used with caution in patients with [[Parkinson's disease]] due to the risk of aggravation of symptoms.


:* Dosage
'''Worsening of Symptoms of Myasthenia Gravis'''


=====Condition2=====
* DITROPAN XL® should be used with caution in patients with [[myasthenia gravis]] due to the risk of aggravation of symptoms.


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
'''Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy'''


<!--Off-Label Use and Dosage (Pediatric)-->
* DITROPAN XL® should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.


<!--Guideline-Supported Use (Pediatric)-->
'''Urinary Retention'''
|offLabelPedGuideSupport======Condition1=====


* Developed by:
* DITROPAN XL® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.


* Class of Recommendation:
'''Gastrointestinal Adverse Reactions'''


* Strength of Evidence:
* DITROPAN XL® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.


* Dosing Information
* DITROPAN XL®, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.


:* Dosage
* DITROPAN XL® should be used with caution in patients who have [[gastroesophageal reflux]] and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate [[esophagitis]].


=====Condition2=====
* As with any other nondeformable material, caution should be used when administering DITROPAN XL® to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.
 
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.
|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.
|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 264: Line 103:
|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
 
|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.


* Description
 


<!--IV Compatibility-->
<!--IV Compatibility-->
Line 318: Line 157:
|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-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* DITROPAN XL®<ref>{{Cite web |title =oxybutynin chloride tablet, extended release  | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36cc9115-bef3-48fa-93ff-bcda24cf26e2}}</ref>
 


<!--Look-Alike Drug Names-->
|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 13:41, 22 May 2015

Oxybutynin (oral)
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.

Black Box Warning

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

Overview

Oxybutynin (oral) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • DITROPAN XL® (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
  • DITROPAN XL® is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Dosage

  • The recommended starting dose of DITROPAN XL® is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.

DOSAGE FORMS AND STRENGTHS

  • DITROPAN XL® extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:
  • 5 mg: Pale yellow, round, tablet with "5 XL" printed on one side with black ink.
  • 10 mg: Pink, round, tablet with "10 XL" printed on one side with black ink.
  • 15 mg: Gray, round, tablet with "15 XL" printed on one side with black ink.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxybutynin (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxybutynin (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Oxybutynin (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxybutynin (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxybutynin (oral) in pediatric patients.

Contraindications

  • DITROPAN XL® is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.

Warnings

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

Angioedema

  • Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Central Nervous System Effects

  • Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
  • DITROPAN XL® should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
  • DITROPAN XL® should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms.

Worsening of Symptoms of Myasthenia Gravis

  • DITROPAN XL® should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.

Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy

  • DITROPAN XL® should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.

Urinary Retention

  • DITROPAN XL® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Gastrointestinal Adverse Reactions

  • DITROPAN XL® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
  • DITROPAN XL®, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.
  • DITROPAN XL® should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
  • As with any other nondeformable material, caution should be used when administering DITROPAN XL® to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Oxybutynin (oral) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Oxybutynin (oral) in the drug label.

=

Drug Interactions

There is limited information regarding Oxybutynin (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Oxybutynin (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxybutynin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Oxybutynin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Oxybutynin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Oxybutynin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Oxybutynin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Oxybutynin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Oxybutynin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Oxybutynin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Oxybutynin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Oxybutynin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Oxybutynin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Oxybutynin (oral) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Oxybutynin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Oxybutynin (oral) in the drug label.

Pharmacology

There is limited information regarding Oxybutynin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Oxybutynin (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Oxybutynin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Oxybutynin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Oxybutynin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Oxybutynin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Oxybutynin (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Oxybutynin (oral) |?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::Oxybutynin (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Oxybutynin (oral) in the drug label.

Precautions with Alcohol

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

Brand Names

  • DITROPAN XL®[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. ↑ "oxybutynin chloride tablet, extended release".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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