Praziquantel comes as a tablet to take by mouth with water and a meal. It is usually taken for one day as three doses; each dose spaced 4 to 6 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take praziquantel exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Praziquantel tablets are marked with 3 notches so that they can easily be split. If your doctor has told you to take only part of a tablet, use your thumbnail to press down on the correct notch and separate the number of parts needed for your dose.
Swallow the tablets or tablet parts whole as soon as you put them into your mouth. Do not chew them, crush them, or hold them in your mouth. The bitter taste of the tablets may cause you to gag or vomit if you keep the tablets in your mouth before swallowing.
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 birth weight, 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.
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