Praziquantel

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]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

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

Overview

Praziquantel is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Cardiac dysrhythmia, Rash Urticaria, Abdominal pain Defecation urgency Diarrhea Hemorrhagic diarrhea Nausea Vomiting, Dizziness Headache Inflammatory disease, acute, CNS Seizure Somnolence, Fever Malaise.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Clonorchiasis

• Dosing Information

• a) The recommended dose for clonorchiasis or opisthorchiasis is 25 milligrams/kilogram/day 3 times a day as a 1-day treatment. The interval between doses should be not less than 4 and not more than 6 hours [24]. The tablets should be taken with meals and washed down with water.

Infection by Opisthorchis viverrini

• Dosing Information

• a) The recommended dose for clonorchiasis or opisthorchiasis is 25 milligrams/kilogram 3 times a day as a 1-day treatment. The interval between doses should be not less than 4 and not more than 6 hours [24]. The tablets should be taken with meals and washed down with water.

Schistosomiasis

• Dosing Information

• a) The recommended adult dose for Schistosoma hematobium, Schistosoma japonicum, Schistosoma mansoni, and Schistosoma mekongi is praziquantel 20 milligrams/kilogram 3 times a day as a 1-day treatment. The interval between the individual doses should not be less than 4 and not more than 6 hours [24].

b) Praziquantel tablets should be swallowed whole (unchewed) and washed down with water during meals. If the tablets or parts of the tablets are kept in the mouth, a bitter taste (which can promote gagging or vomiting) may be experienced[24]. c) Although single dose therapy is effective, the administration of larger doses has been reported in some studies to be associated with a higher incidence of adverse effects than seen with repeated smaller doses [25][13].

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

Infection by Paragonimus

• 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)

Clonorchiasis

• Dosing Information

• a) Safety of praziquantel in children under 4 years of age has not been established [24].

b) The recommended dose for clonorchiasis or opisthorchiasis is 25 milligrams/kilogram 3 times a day as a 1-day treatment. The interval between the individual doses should not be less than 4 hours and not more than 6 hours [24][26]. c) Praziquantel tablets should be swallowed whole (unchewed) and washed down with water during meals. If the tablets or parts of the tablets are kept in the mouth, a bitter taste (which can promote gagging or vomiting) may be experienced[24].

Infection by Opisthorchis viverrini

• Dosing Information

• a) Safety of praziquantel in children under 4 years of age has not been established [24].

b) The recommended dose for clonorchiasis or opisthorchiasis is 25 milligrams/kilogram 3 times a day as a 1-day treatment. The interval between the individual doses should not be less than 4 hours and not more than 6 hours [24][26]. c) Praziquantel tablets should be swallowed whole (unchewed) and washed down with water during meals. If the tablets or parts of the tablets are kept in the mouth, a bitter taste (which can promote gagging or vomiting) may be experienced[24].

Schistosomiasis

• Dosing Information

• a) Safety of praziquantel in children under 4 years of age has not been established [24].

b) The recommended dose for Schistosoma infections in children 4 years of age or older is praziquantel 20 milligrams/kilogram 3 times a day as a 1-day treatment. The interval between the individual doses should not be less than 4 hours and not more than 6 hours [24][26]. c) Praziquantel tablets should be swallowed whole (unchewed) and washed down with water during meals. If the tablets or parts of the tablets are kept in the mouth, a bitter taste (which can promote gagging or vomiting) may be experienced[24].

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

Hymenolepiasis

• 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

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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 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

• A® — B®

Drug Shortage Status

Price

References

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

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