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{{DrugProjectFormSinglePage
{{Praziquantel}}
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'''''For patient information, click <u>[[Praziquantel (patient information)|here]]</u>'''''.
* Content


{{CMG}}
<!--Adult Indications and Dosage-->


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


Praziquantel is an [[anthelmintic]] effective against flatworms.  As of 2005, praziquantel is the primary treatment for human [[schistosomiasis]], for which it is usually effective in a single dose. It is also used to treat [[echinococcosis]], [[cysticercosis]], [[intestine|intestinal]] [[tapeworm]]s and the [[liver fluke|liver flukes]] except for [[fascioliasis]].  In [[veterinary]] medicine it is widely used against [[tapeworm]]s, going by the trade name of Droncit.
* Dosing Information


==Category==
:* Dosage


Anthelmintic
=====Condition2=====


==US Brand Names==
* Dosing Information


BILTRICIDE<sup>®</sup>
:* Dosage


==FDA Package Insert==
=====Condition3=====


'''  [[Praziquantel description|Description]]'''
* Dosing Information
'''| [[Praziquantel clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Praziquantel indications and usage|Indications and Usage]]'''
'''| [[Praziquantel contraindications|Contraindications]]'''
'''| [[Praziquantel warnings and precautions|Warnings and Precautions]]'''
'''| [[Praziquantel adverse reactions|Adverse Reactions]]'''
'''| [[Praziquantel drug interactions|Drug Interactions]]'''
'''| [[Praziquantel overdosage|Overdosage]]'''
'''| [[Praziquantel clinical studies|Clinical Studies]]'''
'''| [[Praziquantel dosage and administration|Dosage and Administration]]'''
'''| [[Praziquantel how supplied|How Supplied]]'''
'''| [[Praziquantel labels and packages|Labels and Packages]]'''


==Mechanism of Action==
:* Dosage


Although the mode of action is not exactly known at present, there is experimental evidence that Praziquantel increases the permeability of the membranes of parasite cells (certain schistosomes) for calcium ions. The drug thereby induces contraction of the parasites resulting in paralysis in the contracted state. The dying parasites are dislodged from their site of action in the host organism and may enter systemic circulation or may be destroyed by host immune reaction (phagocytosis). Additional mechanisms - focal disintegrations and disturbances of oviposition (laying of eggs) - are seen in other types of sensitive parasites.
=====Condition4=====
Another hypothesis on the mechanism of action of praziquantel has been recently reported. The drug seems to interfere with adenosine uptake, in cultured worms. This effect may have therapeutical relevance given that the schistosome, as the taenia and the echinococcus (other praziquantel sensistive parasites), is unable to synthesize purines ''de novo''.


==Historical Perspective==
* Dosing Information


Praziquantel was developed in the laboratories for parasitological research of [[Bayer AG]] in Germany (Elberfeld) in the mid 1970s. Since then it has proven indispensable in more and more indications and is recognized as such by the [[World Health Organization]].
:* Dosage


==Pharmacokinetics==
<!--Off-Label Use and Dosage (Adult)-->


Praziquantel is well (approximately 80%) absorbed from the GI Tract. Due to extensive first pass metabolization only relatively small amounts enter systemic circulation. Praziquantel has a serum halflife of 0.8 to 1.5 hours (metabolites 4 to 5 hours) in adults with normal renal and liver function. In patients with significantly impaired liver function (Child Pugh classes B and C) the serum halflife is increased to 3 to 8 hours. Praziquantel and its metabolites are mainly excreted in the urine, within 24 hours after a single oral dose 70 to 80% are recovered in urine, but less than 0.1% are found as the unchanged drug.
<!--Guideline-Supported Use (Adult)-->
Praziquantel is metabolized through the cytochrome P450 pathway 3A4.  Agents that induce or inhibit Cyp450 3A4 (ie phenytoin, rifampin, azole antifungals) will have an effect the metabolism of praziquantel.
|offLabelAdultGuideSupport======Condition1=====


==Side effects==
* Developed by:


The majority of side-effects develop due to the killing of [[parasites]], release of contents of parasites and consequent host immune reactions. The heavier the parasite burden, the heavier and more frequent the side effects normally are.
* Class of Recommendation:


* Central Nervous System: Frequent are [[dizziness]], [[headache]] and malaise. [[Drowsiness]], [[somnolence]], [[fatigue (physical)|fatigue]] and [[Vertigo (medical)|vertigo]] have also been seen. Almost all patients with cerebral [[cysticercosis]] experience CNS side effects related to the cell-death of the parasites ([[headache]], worsening of preexisting neurological problems, [[seizures]], [[arachnoiditis]], and [[meningism]]). These side effects may be life-threatening and can be reduced by coadministration of [[steroids]]. It is strongly recommended that all patients with cerebral [[cysticercosis]] are hospitalized during treatment.
* Strength of Evidence:  


* GI Tract: Approximately 90% of all patients have [[abdominal pain]] or cramps with or without nausea and vomiting. [[Diarrhea]] may develop and may be severe with colicky. [[Sweating]], [[fever]], and sometimes bloody stools may emerge together with [[diarrhea]].
* Dosing Information


* Liver : Asymptomatic and transient increases of liver enzymes ([[AST]] and [[ALT]]) are noted frequently (up to 27%). No case of symptomatic liver damage has ever been seen so far.
:* Dosage


* Sensitivity Reactions : [[Urticaria]], [[rash]], [[pruritus]] and [[eosinophilia]] in White Blood Counts.
=====Condition2=====


* Other Locations/Body as a Whole : [[Low back pain]], [[myalgia]], [[arthralgia]], [[fever]], [[sweating]], various cardiac [[arrhythmias]], and [[hypotension]].
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


==References==
<!--Non–Guideline-Supported Use (Adult)-->
{{Reflist|2}}
|offLabelAdultNoGuideSupport======Condition1=====


[[Category:Antibiotics]]
* Dosing Information
[[Category:Wikinfect]]
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* 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-->
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<!--Warnings-->
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====Precautions====
 
* Description
 
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=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
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=====Skin and Hypersensitivy Reactions=====
 
 
 
 
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=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
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=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
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|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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* Intravenous
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* Description
 
<!--IV Compatibility-->
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====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
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[[Category:Drug]]

Revision as of 17:56, 24 December 2014

Praziquantel
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

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Black Box Warning

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

Overview

Praziquantel is a that is FDA approved for the 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 Praziquantel in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

ConditionName:
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 Praziquantel 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 Praziquantel 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 Praziquantel in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Praziquantel01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Praziquantel 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.

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

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