Schedule H

Oral

• Tablets: 600 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schistosomiasis (All species — S. haematobium, S. mansoni, S. japonicum)

Parameter Details

Starting dose 20 mg/kg orally

Titration Not applicable (single-day regimen)

Usual dose 20 mg/kg × 3 doses at 4–6 hour intervals (Total: 60 mg/kg/day)

Maximum dose 60 mg/kg/day

Duration Single day

Key notes Administer with food to enhance absorption. Repeat after 2–4 weeks in severe or persistent infections (specialist discretion).

1. Neurocysticercosis (Taenia solium — parenchymal disease)

Specialist supervision mandatory

Parameter Details

Starting dose 50 mg/kg/day orally in 3 divided doses

Titration Not applicable

Usual maintenance dose 50 mg/kg/day

Maximum dose 50 mg/kg/day

Duration 14–15 days

Key notes Initiate corticosteroids (dexamethasone 0.1 mg/kg/day or prednisolone) 1 day before praziquantel. Co-administer antiepileptic drugs if seizures present. Rule out ocular cysticercosis before initiating therapy. Monitor for raised intracranial pressure.

1. Cysticercosis (Non-neurological — subcutaneous, muscular)

Parameter Details

Starting dose 50 mg/kg/day orally in 3 divided doses

Titration Not applicable

Usual maintenance dose 50 mg/kg/day

Maximum dose 50 mg/kg/day

Duration 14 days

Key notes Monitor for inflammatory reactions secondary to cyst degeneration. Consider corticosteroid cover in heavy parasite burden.

1. Taeniasis (T. saginata, T. solium — intestinal)

Parameter Details

Starting dose 5–10 mg/kg orally as single dose

Titration Not applicable

Usual maintenance dose Not applicable (single-dose therapy)

Maximum dose 10 mg/kg

Duration Single dose

Key notes Administer with food. For T. solium, advise patient regarding risk of autoinfection and hygiene measures.

1. Hymenolepiasis (Hymenolepis nana)

Parameter Details

Starting dose 25 mg/kg orally as single dose

Titration Not applicable

Usual maintenance dose Not applicable

Maximum dose 25 mg/kg

Duration Single dose; repeat at 10 days if necessary

Key notes Repeat dosing recommended due to autoinfection cycle. Follow-up stool examination at 4 weeks.

1. Clonorchiasis / Opisthorchiasis (Liver flukes)

Parameter Details

Starting dose 25 mg/kg orally

Titration Not applicable

Usual maintenance dose 25 mg/kg × 3 doses per day (Total: 75 mg/kg/day)

Maximum dose 75 mg/kg/day

Duration 1 day

Key notes Administer doses at 4–6 hour intervals with food.

1. Paragonimiasis (Lung fluke)

Parameter Details

Starting dose 25 mg/kg orally

Titration Not applicable

Usual maintenance dose 25 mg/kg × 3 doses per day (Total: 75 mg/kg/day)

Maximum dose 75 mg/kg/day

Duration 2–3 days

Key notes Extend to 3 days for heavy infections or extrapulmonary disease.

Secondary Indications — Adults (Off-label, if any)

Not applicable — No clearly supported off-label indications documented in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Schistosomiasis ≥1 year 60 mg/kg/day in 3 divided doses (20 mg/kg per dose at 4–6 hour intervals) Single day WHO supports use from 1 year. Tablets may be crushed and mixed with soft food.

Taeniasis ≥1 year 5–10 mg/kg as single dose Single dose Lower dose (5 mg/kg) for T. saginata; higher (10 mg/kg) for T. solium.

Hymenolepiasis ≥1 year 25 mg/kg as single dose Single dose; repeat at 10 days if required Follow-up stool examination recommended.

Neurocysticercosis ≥2 years 50 mg/kg/day in 3 divided doses 14 days Mandatory co-administration of corticosteroids and antiepileptic drugs. Specialist supervision essential. MRI required before initiation.

Paragonimiasis ≥1 year 75 mg/kg/day in 3 divided doses 2–3 days —

Clonorchiasis / Opisthorchiasis ≥1 year 75 mg/kg/day in 3 divided doses 1 day —

Safety Monitoring (All Paediatric Patients):

• Monitor for abdominal pain, nausea, vomiting

• In neurocysticercosis: monitor for seizures, signs of raised intracranial pressure

• Baseline and post-treatment stool examination as applicable

Secondary Indications — Paediatric (Off-label, if any)

Indication Age Dose Notes Evidence

Schistosomiasis in infants 6 months to <1 year 60 mg/kg/day in 3 divided doses Specialist only — OFF-LABEL WHO programmatic data supports use in endemic settings under close supervision. Very close monitoring required.

Statement: Praziquantel is not routinely recommended below 1 year of age. Use in infants aged 6 months to <1 year requires specialist supervision and is considered off-label in India.

Mild to moderate impairment No dose adjustment required

• Known hypersensitivity to praziquantel or any excipient

• Ocular cysticercosis (risk of irreversible inflammatory damage to intraocular structures)

• Concomitant use with rifampicin (markedly reduces praziquantel efficacy)

• Hepatic impairment — altered drug metabolism and risk of accumulation

• Seizure disorders — may exacerbate symptoms, especially in neurocysticercosis

• High parasite burden — increased risk of inflammatory reactions from parasite death

• Cardiac arrhythmias (pre-existing) — rare reports of QT effects

• Patients requiring tasks demanding alertness (dizziness, sedation possible)

• Pregnancy and lactation — use under specialist guidance

Parameter Details

Overall safety Generally considered safe; no major teratogenic risk documented (WHO, Indian experience)

Preferred timing Defer to 2nd or 3rd trimester if clinically feasible

When to use When benefit outweighs risk — particularly for schistosomiasis in endemic areas

Preferred alternatives None; praziquantel is the drug of choice for susceptible helminths

Monitoring Maternal hepatic function; fetal growth (routine antenatal surveillance)

Parameter Details

Compatibility Compatible with breastfeeding

Drug levels in milk Low (approximately 0.25% of maternal dose)

WHO recommendation Breastfeeding may be withheld for 24 hours post-dose, though not mandatory

Preferred alternatives Not required; praziquantel is acceptable

Infant monitoring Observe for sedation, feeding difficulties, GI disturbance (rare)

Parameter Recommendation

Starting dose Standard adult dose

Titration Not typically required

Special considerations Assess hepatic and renal function before initiation. Monitor for CNS effects (confusion, dizziness). Evaluate swallowing ability — tablets are large (600 mg). Consider crushing and mixing with food if dysphagia present.

Interacting Drug Effect Mechanism Recommendation

Rifampicin Markedly reduced praziquantel efficacy (up to 85% reduction in plasma levels) Strong CYP3A4 inducer Avoid concomitant use. Space rifampicin by at least 4 weeks before praziquantel if treatment is essential.

Phenytoin Reduced praziquantel levels CYP3A4 induction Avoid if possible; consider alternative antiepileptic or increased praziquantel dose under specialist guidance.

Carbamazepine Reduced praziquantel levels CYP3A4 induction Avoid if possible; use alternative antiepileptic where feasible.

Interacting Drug Effect Recommendation

Ketoconazole / Itraconazole Increased praziquantel plasma levels Monitor for CNS and GI adverse effects

Dexamethasone May modestly reduce praziquantel levels Use concomitantly as required in neurocysticercosis; clinical impact usually not significant

Cimetidine Increased praziquantel exposure (reduced first-pass metabolism) Monitor for adverse effects

Chloroquine May reduce praziquantel plasma levels Mechanism unclear; avoid co-administration on same day if possible

Phenobarbital / Valproate Variable effects on praziquantel metabolism Monitor clinical response and seizure control

• Abdominal discomfort and pain

• Nausea and vomiting

• Dizziness

• Headache

• Malaise and fatigue

• Transient fever (particularly with parasite death)

• Urticaria or pruritus (usually mild and self-limiting)

Adverse Effect Notes

Seizures Particularly in neurocysticercosis — related to inflammatory response around dying cysts

Severe hypersensitivity reactions Rare; includes anaphylaxis

Hepatotoxicity Elevated transaminases; usually transient

Ocular complications If occult ocular cysts are present — may cause vision-threatening inflammation

Cardiac arrhythmias Very rare; mechanism unclear

Intracranial hypertension In neurocysticercosis — requires immediate management

Phase Parameters

Baseline Liver function tests (LFTs), complete blood count (CBC), neurological examination (if CNS involvement suspected), MRI brain (mandatory before treating suspected neurocysticercosis), ophthalmological examination (to rule out ocular cysticercosis)

During therapy In neurocysticercosis: Monitor for seizures, signs of raised intracranial pressure (headache, vomiting, altered sensorium)

Post-treatment Stool examination (for intestinal helminths), serology (where applicable), repeat imaging in neurocysticercosis (usually at 3–6 months)

• Distocide (Bayer)

• Cysticide

• Praziquantel (generic — various manufacturers)

• Zentrazide

Government supply Available free under Neglected Tropical Disease (NTD) programmes in endemic regions

Note: Pricing may vary by brand and region.

1. Always rule out ocular cysticercosis before initiating therapy for suspected cysticercosis — MRI brain and ophthalmological examination are essential.

1. Corticosteroids should be started 1 day before praziquantel in neurocysticercosis to mitigate inflammatory reactions from dying cysts.

1. Tablets are large (600 mg) — may be crushed and administered with soft food or porridge for children and patients with swallowing difficulties.

1. Rifampicin drastically reduces praziquantel efficacy — discontinue rifampicin at least 4 weeks before treatment if feasible, or use alternative antiparasitic agent.

1. Test-of-cure should be performed using species-specific methods: stool microscopy for intestinal helminths, serology or imaging for tissue cysticercosis.

1. Repeat dosing may be necessary in heavy infections or when the parasite lifecycle allows reinfection (e.g., H. nana).

praziquantel; anthelmintic; schistosomiasis; neurocysticercosis; taeniasis; cysticercosis; paragonimiasis; paediatric-dosing; hepatic-caution; pregnancy-compatible; NLEM-India; NTD

RxIndia v1.1 — 10 Jul 2025

• CDSCO Product Information

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Drug Formulary

• WHO Model List of Essential Medicines

• WHO Guidelines for Preventive Chemotherapy in Helminth Infections

• NCDC Guidelines on Parasitic Diseases

• Harrison's Principles of Internal Medicine

• IAP Drug Formulary (Paediatric dosing)

• ICMR Guidelines on Helminth Infections