Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai: 400013, India
Praziquantel 600mg Tablets is indicated in adults and children for large scale preventive chemotherapy interventions for the control of schistosoma infections due to various types of blood fluke worms (Schistosoma mansoni, Schistosoma haematobium, Schistosoma japonicum, Schistosoma mekongi, Schistosoma intercalatum) following the recommendations of the WHO Global Programme to Eliminate Schistosomiasis.
Groups targeted for treatment are:
| Height (cm/inches) | Number of tablets (mg) of Praziquantel 600mg Tablets | 94-109 cm (37-42 inches) | 1 tablet (600 mg) | |
|---|---|---|---|---|
| 110-124 cm (43-48 inches) | 1 ½ tablets (900 mg) | |||
| 125-137 cm (49-53 inches) | 2 tablets (1200 mg) | |||
| 138-149 cm (54-58 inches) | 2 ½ tablets (1500 mg) | |||
| 150-159 cm (59-62 inches) | 3 tablets (1800 mg) | |||
| 160-177 cm (63-69 inches) | 4 tablets (2400 mg) | |||
| ≥178 cm (>70 inches) | 5 tablets (3000 mg) |
Intervention frequency is determined by the prevalence of infection in school-age children or visible haematuria. In high-transmission areas, treatment may have to be repeated every year for a number of years. Monitoring is essential to determine the impact of control interventions.
Praziquantel 600mg Tablets should be taken once a year in high-risk communities, once every 2 years in moderate-risk communities, and twice during the period of primary schooling age in low-risk communities (e.g. once at entry and once on exit). In low risk communities adults should be treated only if infection is suspected.
High-risk community is defined as detection of intestinal and urinary schistosomiasis ≥50% by parasitological methods or ≥ 30 % by questionnaire for visible haematuria in 50 children from the upper classes of a selection of schools in areas around water.
Moderate-risk community is defined as detection of intestinal and urinary schistosomiasis ≥10% but <50% by parasitological methods or <30% by questionnaire for visible haematuria. Low-risk community is defined as detection of intestinal and urinary schistosomiasis <10% by parasitological methods.
Oral use.
Praziquantel 600mg Tablets should be taken unchewed during meals.
Praziquantel 600mg Tablets should be administered with caution to patients with moderate to severe liver impairment (see section 4.4).
No dose adjustments for renal impairment are necessary (see section 4.4).
No special precautions are required in the elderly.
There is no documented information on the safety of praziquantel for children under 4 years of age (or under 94 cm height). In principle, these children should therefore be excluded from treatment or mass preventive treatment but can be treated on an individual case by case basis by medical personnel.
Information on overdosage in humans is not available.
Treatment should be supportive and provide symptomatic care. Activated charcoal may reduce absorption of the medicine if given within one to two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
Shelf life: 24 months.
Do not store above 30°C.
For 500 pack size: Discard the product 28 days after initial opening.
180 cc or 900 cc white HDPE container with white HDPE screw caps having 2 silica gel bags of 1gm and Rayon Sani coil (Pack sizes: 100 and 500 tablets).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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