Finished product reference
Praziquantel
Tablet · Oral · 600 mg
- List code
- 1041
- Pharmacologic class
- Anthelmintic
What it is and how it works
Mechanism of Action Praziquantel is an anthelmintic drug .
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
Dosage and administration (summary)
Schistosomiasis : 20 mg/kg body weight 3 times a day separated by 4 to 6 hours for 1 day only. Clonorchiasis and Opisthorchiasis : 25 mg/kg 3 times a day separated by 4 to 6 hours for 1 day only. Take with water during meals. Do not chew or keep segments in the mouth. For pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid. For additional administration instructions see the full prescribing information. 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.
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 .
Warnings and precautions
Clinical Deterioration : Potentially life threatening clinical deterioration can occur in patients treated during the acute phase of schistosomiasis. 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. Potential Lack of Efficacy for Acute Schistosomiasis : This has been reported in observational studies .
Pregnancy
Pregnancy 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) .
Storage and supply
Praziquantel tablets, USP are supplied as 600 mg tablets containing praziquantel, USP. The tablets are white to off white, film-coated, oblong tablet with three scores coded with “PAR” on one side “231” on the reverse side. Praziquantel tablets, USP 600 mg are available in bottles of 6 tablets (NDC 49884-231-83).
Source: Praziquantel (Praziquantel) — US FDA prescribing information, 2026-08-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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