Anthelmintic

Praziquantel

Approved 27 Nov 2017OralTablet

Indications

Praziquantel tablets are indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Praziquantel tablets are an anthelmintic indicated in patients aged one year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example , Schistosoma mekongi , Schistosoma japonicum , Schistosoma mansoni and Schistosoma hematobium ), and, Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis and Opisthorchis viverrini

Contraindications

Praziquantel is contraindicated in: Patients who previously have shown hypersensitivity to praziquantel or any of the excipients in praziquantel tablets. Patients with ocular cysticercosis; since parasite destruction within the eye that occurs because of hypersensitivity reaction to the dead parasite after treatment may cause irreversible lesions, ocular cysticercosis must not be treated with praziquantel. Patients taking strong Cytochrome P450 3A enzyme (CYP 3A) inducers, such as rifampin [see Warnings and Precautions ( 5.6) and Drug Interactions ( 7.1 , 7.2 )] .

Known hypersensitivity to praziquantel or any of its ingredients. ( 4.1 ) Concomitant administration with strong Cytochrome P450 3A enzyme (CYP 3A) inducers such as rifampin. ( 4 , 5.6 , 7.1 )

Warnings and precautions

Clinical Deterioration : Potentially life threatening clinical deterioration can occur in patients treated during the acute phase of schistosomiasis. ( 5.1 ) Central Nervous System (CNS) Effects : Praziquantel can exacerbate central nervous system pathology due to schistosomiasis. Consider whether to administer to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis.

( 5.2 ) Potential Lack of Efficacy for Acute Schistosomiasis : This has been reported in observational studies ( 5.3 ). Cardiac Arrhythmias: Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with praziquantel administration. Monitor patients with cardiac arrhythmias during treatment ( 5.4 ).

At a glance

Brand name: Praziquantel
Pharmacologic class: Anthelmintic
Route: Oral
Dosage form: Tablet
Applicant: PH Health
Status: Prescription
FDA approval: 27 Nov 2017
Application: ANDA208820-001

Indications

Contraindications

Known hypersensitivity to praziquantel or any of its ingredients. ( 4.1 ) Concomitant administration with strong Cytochrome P450 3A enzyme (CYP 3A) inducers such as rifampin. ( 4 , 5.6 , 7.1 )

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Published studies have not identified an association with praziquantel use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) . In animal reproduction studies conducted in pregnant rats and rabbits no adverse developmental outcomes were observed with oral administration of praziquantel during organogenesis at approximately 0.65 times (rats) or 1.3 times (rabbits) the highest recommended human daily dose of 75 mg/kg/day, based on body surface area.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Two randomized controlled clinical trials have been conducted using praziquantel for the treatment of schistosoma infection in pregnant women.

In one randomized controlled trial in pregnant women with schistosoma ( S. japonicum) infection, 186 pregnant women were treated with praziquantel compared to 184 women who received placebo. Treatment with praziquantel during pregnancy had no effect on birthweight, and there were no differences in rates of miscarriage, fetal death and major birth defects between the praziquantel-treated and control patients. In another randomized controlled trial that included 2,507 pregnant women in Uganda, 18% of women were infected with schistosoma infection.

Treatment with praziquantel during pregnancy had no effect on mean birth weight, perinatal mortality or major birth defects. In other published studies, including a retrospective observational study, case series and case reports, there have been no reports of major birth defects, stillbirths or other adverse pregnancy outcomes associated with the use of praziquantel during pregnancy. Animal Data No evidence of fetal harm was observed in rats and rabbits at praziquantel dose levels of 30 to 300 mg/kg body weight given repeatedly by oral administration during the period of organogenesis.

These doses were up to 0.65 times (rats) or 1.3 times (rabbits) the highest recommended human daily dose of 75 mg/kg/day, based on body surface area.

Adverse reactions

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: Clinical Deterioration [see Warnings and Precautions (5.1) ] Central Nervous System (CNS) Effects [see Warnings and Precautions (5.2) ] Potential Lack of Efficacy During the Acute Phase of Schistosomiasis [see Warnings and Precautions (5.3) ] Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Hepatic Impairment in Hepatosplenic Schistosomiasis Patients [see Warnings and Precautions (5.5) ] Concomitant Administration with Strong Cytochrome P450 Inducers [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of praziquantel were identified in clinical studies, published literature or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions were observed in both adults and pediatric patients: General disorders and administration site conditions: malaise, pyrexia Nervous system disorders: headache, dizziness Gastrointestinal disorders: abdominal discomfort, nausea Skin and subcutaneous tissue disorders: urticaria Such adverse reactions may be more frequent and/or serious in patients with a heavy worm burden.

Additional adverse reactions reported from worldwide post marketing experience and from publications with praziquantel and various formulations of praziquantel include: Blood and lymphatic system disorders: eosinophilia Cardiac disorders: arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks) Ear and labyrinth disorders: vertigo, tinnitus Eye disorders: visual disturbance Gastrointestinal disorders: abdominal pain, bloody diarrhea, vomiting General disorders and administration site conditions: polyserositis, asthenia, fatigue, gait disturbance Hepatobiliary disorders: hepatitis Immune system disorders: allergic reaction, generalized hypersensitivity, anaphylactic reaction Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: convulsion, somnolence, intention tremor Respiratory, thoracic and mediastinal disorders: pneumonitis, dyspnea, wheezing Skin and subcutaneous tissue disorders: pruritus, rash, Stevens-Johnson syndrome Pediatric patients 1 to 17 years of age treated with praziquantel tablets and various formulations of praziquantel experienced similar adverse reactions as those observed in adult patients.

The adverse reactions reported were malaise, headache, dizziness, abdominal discomfort (with or without nausea), pyrexia and urticaria. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Praziquantel

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Praziquantel

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Clinical Deterioration

5.2Central Nervous System (CNS) Effects

5.3Potential Lack of Efficacy During the Acute Phase of Schistosomiasis Data

5.4Cardiac Arrhythmias

5.5Hepatic Impairment in Hepatosplenic Schistosomiasis Patients

Interactions

7.1CYP 3A Inducers Strong and Moderate CYP 3A Inducers

7.2CYP450 Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information