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PRAZIQUANTEL is a brand name for Praziquantel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Schistosomiasis : 20 mg/kg body weight 3 times a day separated by 4 to 6 hours for 1 day only. 1 ) Clonorchiasis and Opisthorchiasis : 25 mg/kg 3 times a day separated by 4 to 6 hours for 1 day only. 1 ) Take with water during meals.
Do not chew or keep segments in the mouth. 2 ) For pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid. 2 ) For additional administration instructions see the full prescribing information.
1 Recommended Dosage Schistosomiasis The recommended dosage for the treatment of schistosomiasis is 20 mg/kg bodyweight administered orally three times a day separated by 4 to 6 hours, for 1 day only. Clonorchiasis and Opisthorchiasis The recommended dosage for the treatment of clonorchiasis and opisthorchiasis is 25 mg/kg bodyweight administered orally three times a day separated by 4 to 6 hours for 1 day only.
2 Administration Take tablets with water during meals. Do not chew or keep the tablets (or parts of tablets) in the mouth; the bitter taste may cause gagging or vomiting. To prevent choking in pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid.
Use crushed or disintegrated tablets within 1 hour of mixing. Praziquantel 600 mg tablets have three scores which can be split into four segments at the scores. When broken, each of the four segments contains 150 mg of praziquantel so that the dosage can be adjusted to the patient’s bodyweight.
Segments are broken off by pressing the score (notch) with thumbnails. If one-quarter of a tablet is required, this is best achieved by breaking the segment from the outer end.
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.
5 WARNINGS AND PRECAUTIONS Clinical Deterioration : Potentially life threatening clinical deterioration can occur in patients treated during the acute phase of schistosomiasis. 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. 3 ).
Cardiac Arrhythmias:
Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with praziquantel administration. 4 ). 1 Clinical Deterioration The use of praziquantel in patients with schistosomiasis may be associated with clinical deterioration (for example, paradoxical reactions, serum sickness Jarisch-Herxheimer like reactions: sudden inflammatory immune response suspected to be caused by the release of schistosomal antigens).
These reactions predominantly occur in patients treated during the acute phase of schistosomiasis. They may lead to potentially life-threatening events, for example, respiratory failure, encephalopathy, papilledema, and/or cerebral vasculitis.
2 Central Nervous System (CNS) Effects Praziquantel can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis, or Taenia solium cysticercosis. As a general rule, consider whether to administer praziquantel to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis unless the potential benefit justifies the potential risk.
Hospitalize the patient for duration of treatment when schistosomiasis or fluke infection is found to be associated with cerebral cysticercosis. 3 Potential Lack of Efficacy During the Acute Phase of Schistosomiasis Data from two observational cohort studies in patients indicate that treatment with praziquantel in the acute phase of infection may not prevent progression from asymptomatic infection to acute schistosomiasis, or from asymptomatic infection/acute schistosomiasis into chronic phase.
4 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.
2 )] . Known hypersensitivity to praziquantel or any of its ingredients. 1 ) Concomitant administration with strong Cytochrome P450 3A enzyme (CYP 3A) inducers such as rifampin. 1 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The adverse reactions reported were malaise, headache, dizziness, abdominal discomfort (with or without nausea), pyrexia and urticaria. gov/medwatch.
4 Cardiac Arrhythmias Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks has been observed with praziquantel administration. Monitor patients with cardiac arrhythmias during treatment. 3) ]. Monitor patients for adverse reactions when administering the recommended dose of praziquantel to hepatosplenic schistosomiasis patients with moderate or severe liver impairment (Child-Pugh Class B or C).
6 Concomitant Administration with Cytochrome P450 Enzyme Inducers Strong Cytochrome P450 3A Enzyme (CYP 3A) Inducers Concomitant administration of strong CYP 3A inducers, such as rifampin, with praziquantel is contraindicated since therapeutically effective levels of praziquantel are unlikely to be achieved.
3) ]. Moderate CYP 3A Inducers Avoid concomitant administration of praziquantel with moderate CYP 3A inducers, such as efavirenz, due to risk of a clinically significant decrease in praziquantel plasma concentrations which may lead to reduced therapeutic effect of praziquantel.
1)] . In patients receiving a clinically significant CYP 3A inducer drug who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered, where possible. 1)] . In patients receiving a clinically significant CYP 3A inducer drug whose treatment could be delayed, discontinue the CYP 3A inducer drug at least 2 weeks to 4 weeks before administration of praziquantel and, where possible, consider starting alternative medications that are not CYP 3A inducers.
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