Risperidone (oral): Difference between revisions

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<small>'''''Synonyms / Brand Names:''''' Risperidona, Risperidonum, Risperdal, Risperdal Consta, Risperdal M-Tab, Risperidal M-Tab, Risperin, Rispolept, Rispolin, Sequinan</small>
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{{CMG}}


==Dosing and Administration==
<!--Overview-->
'''Schizophrenia'''
<br>
*Usual initial dose: Risperidone can be administered on either a BID or a QD schedule. In early clinical trials, Risperidone was generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day. Subsequent controlled trials have indicated that total daily Risperidone doses of up to 8 mg on a QD regimen are also safe and effective. However, regardless of which regimen is employed, in some patients a slower titration may be medically appropriate. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for the active metabolite would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, small dose increments/decrements of 1–2 mg are recommended.
'''Bipolar mania'''
*Usual dose: Risperidone should be administered on a once daily schedule, starting with 2 mg to 3 mg per day. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments/decrements of 1 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1–6 mg per day. Risperidone doses higher than 6 mg per day were not studied.
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[[{{PAGENAME}}#FDA Package Insert Resources|FDA Package Insert Resources]]
<br></font size><small>Indications, Contraindications, Side Effects, Drug Interactions, etc.</small><font size="4"><br>
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[http://www.pace-med-apps.com/gfrcalc.htm Calculate Creatine Clearance]
<br></font size><small>On line calculator of your patients Cr Cl by a variety of formulas.</small><font size="4"><br>
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[http://home.earthlink.net/~sensei11/convert.htm Convert pounds to Kilograms]
<br></font size><small>On line calculator of your patients weight in pounds to Kg for dosing estimates.</small><font size="4"><br>
<br> [[{{PAGENAME}}#Publication Resources|Publication Resources]]
<br></font size><small>Recent articles, WikiDoc State of the Art Review, Textbook Information</small><font size="4"><br>
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[[{{PAGENAME}}#Trial Resources|Trial Resources]]
<br></font size><small>Ongoing Trials, Trial Results</small><font size="4"><br>
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[[{{PAGENAME}}#Guidelines & Evidence Based Medicine Resources|Guidelines & Evidence Based Medicine Resources]]
<br></font size><small>US National Guidelines, Cochrane Collaboration, etc.</small><font size="4"><br>
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[[{{PAGENAME}}#Media Resources|Media Resources]]
<br></font size><small>Slides, Video, Images, MP3, Podcasts, etc.</small><font size="4"><br><br>
[[{{PAGENAME}}#Patient Resources|Patient Resources]]
<br></font size><small>Discussion Groups, Handouts, Blogs, News, etc.</small><font size="4"><br>
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[[{{PAGENAME}}#International Resources|International Resources]]
<br></font size><small>en Español</small><font size="4"><br>
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==FDA Package Insert Resources==
|genericName=
[[{{PAGENAME}} indications|Indications]]
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[[{{PAGENAME}} contraindications|Contraindications]]
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[[{{PAGENAME}} side effects|Side Effects]]
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[[{{PAGENAME}} drug interactions|Drug Interactions]]
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[[{{PAGENAME}} precautions|Precautions]]
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[[{{PAGENAME}} overdose|Overdose]]
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[[{{PAGENAME}} instructions for administration|Instructions for Administration]]
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[[{{PAGENAME}} how supplied|How Supplied]]
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[[{{PAGENAME}} pharmacokinetics and molecular data|Pharmacokinetics and Molecular Data]]
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[http://www.fda.gov/medwatch/SAFETY/2003/03SEP_PI/Risperdal_PI.pdf FDA label]
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[http://google2.fda.gov/search?q={{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}}&x=0&y=0&client=FDA&site=FDA&lr=&proxystylesheet=FDA&output=xml_no_dtd&getfields=* FDA on {{PAGENAME}}]
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</font size><small>[[{{PAGENAME}}#Dosing and Administration|Return to top]]</small><font size="4">
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==Publication Resources==
[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&db=pubmed&term={{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}} Most Recent Articles on {{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}]
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[[{{PAGENAME}} detailed information|WikiDoc State of the Art Review]]
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</font size><small>[[{{PAGENAME}}#Dosing and Administration|Return to top]]</small><font size="4">
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==Trial Resources==
[http://clinicaltrials.gov/search/open/condition={{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}} Ongoing Trials with {{PAGENAME}} at Clinical Trials.gov]
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==Guidelines & Evidence Based Medicine Resources==
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</font size><small>[[{{PAGENAME}}#Dosing and Administration|Return to top]]</small><font size="4">
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==Patient Resources==
a
[[{{PAGENAME}} (patient information)|Patient Information from National Library of Medicine]]
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[http://www.google.com/search?hl=en&q={{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}}+more:for_patients&cx=disease_for_patients&sa=N&oi=cooptsr&resnum=0&ct=col3&cd=1  Patient Resources on {{PAGENAME}}]
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</font size><small>[[{{PAGENAME}}#Dosing and Administration|Return to top]]</small><font size="4">
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==International Resources==
|drugClass=
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{{FDA}}


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Revision as of 20:39, 1 December 2014

Risperidone (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];

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

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

Overview

Risperidone (oral) is a that is FDA approved for the {{{indicationType}}} of . 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)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

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

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Risperidone (oral) 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

There is limited information regarding Postmarketing Experience of Risperidone (oral) 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

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

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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  2. "http://www.ismp.org". External link in |title= (help)


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