Praziquantel is an anthelmintic used in most schistosome and many cestode infestations. Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release. You have reached the maximum number of saved studies (100). Description: Praziquantel is a pyrazinoisoquinoline anthelmintic agent w/ a broad spectrum of activity against trematodes (flukes) and cestodes (tapeworms). Praziquantel effects the permeability of the cell membrane resulting in the contraction of schistosomes. Side effects are uncommon but may include lack of appetite, vomiting, diarrhea, drooling, or tiredness. Praziquantel is an anthelmintic used in most schistosome and many cestode infestations. [ Time Frame: Collected just before the dose, 24 hours after the dose and at either 20 weeks after the dose (early gestation subjects) or 10-14 days after the dose (late gestation and lactating postpartum subjects). Praziquantel is a racemate derivative of pyrazinoisoquinoline and is effective against many species of cestodes and trematodes. [, McManus DP, Loukas A: Current status of vaccines for schistosomiasis. History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration. PRAZIQUANTEL SUMMARY REPORT (1) 1. All requests for cancellation and reversal of credit card charges shall be submitted by Mercury Drug to the issuing bank for processing and approval in accordance with banking rules and regulations. In general, drugs that inhibit hepatic metabolism via the microsomal CYP450 enzyme system increase the bioavailability of praziquantel and potent CYP450 enzyme inducers may decrease praziquantel serum concentrations. This study is linked to Division of Microbiology and Infectious Disease (DMID) protocol 06-0039. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The effect is more marked on adult worms compared to young worms. Material Safety Data Sheet or SDS for Praziquantel 500022 from Merck for download or viewing in the browser. Clin Microbiol Rev. Then someone will say “Kusuri doesn’t work anymore.” That seems to be what’s happening with Praziquantel and I’ll get to that later. This protocol will enroll 15 pregnant women in early pregnancy (12-16 weeks gestation), 15 pregnant women in late pregnancy (30-36 weeks gestation) and 15 lactating nonpregnant women between 5 and 7 months postpartum. Praziquantel is used to treat schistosomiasis, also known as snail fever or bilharzia, an infection of the urinary tract or bowels, caused by schistosoma (blood fluke), a flatworm parasite. Women must be: age 18 or older, otherwise healthy without disease of any major organ system, without history of seizures, chronic medical problem or any neurologic disorders, without history of severe allergic reaction to PZQ and willing to provide informed consent to participate. Serial breast milk samples will be collected from lactating women. Outcome Measures. [, Li XQ, Bjorkman A, Andersson TB, Gustafsson LL, Masimirembwa CM: Identification of human cytochrome P(450)s that metabolise anti-parasitic drugs and predictions of in vivo drug hepatic clearance from in vitro data. Praziquantel is also used to treat infection with liver flukes, caused by a type of worm found in East Asia. Black, tarry stools. However, despite its use in millions of patients for over 40 years its molecular mechanism of action remains elusive. blurred or loss of vision. Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Why Should I Register and Submit Results? BILTRICIDE® (praziquantel) is a trematodicide provided in tablet form for the oral treatment of schistosome infections and infections due to liver fluke. Infected with Schistosomiasis (S.) japonicum. BILTRICIDE (praziquantel) is 2- (cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyrazino [2, 1-a] isoquinolin-4-one with the molecular formula; C 19 H 24 N 2 O 2 . Vital signs should be in normal range (systolic blood pressure: 90 to 140 millimeters of mercury [mmHg]; diastolic blood pressure: 50 to 90 mmHg; pulse rate: 45 to 90 beats per minute [bpm]; oral body temperature between 35.0 degree centigrade [°C] to 37.5°C) 45 women in 3 cohorts (15 early pregnancy: 12-16 weeks gestation; 15 late pregnancy: 30-36 weeks gestation; and 15 lactating nonpregnant women who are 5-7 months (inclusive) postpartum) given praziquantel (PZQ), 60 mg/kg orally in split dose (30 mg/kg each) separated by 3 hours. 2002 Nov;72(5):505-13. doi: 10.1067/mcp.2002.129319. Praziquantel is an unlicensed drug. In practice, treatment of schistosomiasis is withheld for both pregnant and lactating post partum women in the Philippines as well as other countries endemic for schistosomiasis. Build effective decision support tools with the industry’s most comprehensive, Easily connect various identifiers back to our datasets, InChI=1S/C19H24N2O2/c22-18-13-20(19(23)15-7-2-1-3-8-15)12-17-16-9-5-4-6-14(16)10-11-21(17)18/h4-6,9,15,17H,1-3,7-8,10-13H2, 2-cyclohexanecarbonyl-1H,2H,3H,4H,6H,7H,11bH-piperazino[2,1-a]isoquinolin-4-one, O=C(C1CCCCC1)N1CC2N(CCC3=CC=CC=C23)C(=O)C1, Accelerate your drug discovery research with our ADMET & drug target dataset, Power your clinical software with the most comprehensive allergy info on the market, P02BA — Quinoline derivatives and related substances, P — ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS, Antiparasitic Products, Insecticides and Repellents, Quinoline Derivatives and Related Substances, Human Immunodeficiency Virus (HIV) Infections, Predicted MS/MS Spectrum - 10V, Positive (Annotated), Predicted MS/MS Spectrum - 20V, Positive (Annotated), Predicted MS/MS Spectrum - 40V, Positive (Annotated), Predicted MS/MS Spectrum - 10V, Negative (Annotated), Predicted MS/MS Spectrum - 20V, Negative (Annotated), Predicted MS/MS Spectrum - 40V, Negative (Annotated), LC-MS/MS Spectrum - LC-ESI-QTOF , positive, splash10-03di-0019000000-066af1bbcb832fac2ff4, splash10-0udi-0092000000-2572aab54fdc9ff2617e, splash10-0udi-0790000000-bba67a778d41524cdf76, splash10-00e9-0910000000-412442e38f79438b5893, splash10-0089-0900000000-b663739905edd86c61cb, LC-MS/MS Spectrum - LC-ESI-QFT , positive, splash10-0ik9-0049000000-02c2bbc25fcb21061ef8, splash10-0udi-2190000000-eca5b2601627401a5544, splash10-0f89-8980000000-5102a741f0625afd5c7a, splash10-001i-5910000000-2a141277a2d28d23bfd0, splash10-001i-4900000000-77a7f036670b581c354c, splash10-001i-3900000000-21cde0d9fc368991b837, splash10-03di-0019000000-9fdf91e83d7fd02342cc, splash10-0udi-0092000000-0dbdbc1e5a8153d5764a, splash10-0udi-0490000000-472ed6570d02d80aef23, splash10-0fl0-0920000000-4b4b7e731ba9ab20d076, splash10-0089-0900000000-c5ff862373e835bc247f, splash10-0w29-0598000000-5f9aeabd10ef70166cb6, splash10-0ik9-2698000000-8cf56d1fd2138bc420ec. Praziquantel is a synthetic anthelmintic agent that is structurally unrelated to other currently available anthelmintic agents. Caloocan City Monumento. Early pregnancy cohort: pregnant, between 12-16 weeks gestation. Safety assessments will be performed on pregnant women and their infants through 1 month postpartum, and on postpartum women through 2 weeks post dosing. Inclusion criteria for the study are as follows: Presence of significant disease/illness that is either acute or chronic. 2008 Jan;21(1):225-42. doi: 10.1128/CMR.00046-07. Praziquantel is a prescription drug used as anti-worm medication. Praziquantel works by causing severe spasms and paralysis of the worms' muscles. This will be defined by history, physical examination, ultrasound (if pregnant) and laboratory assessment. This paralysis is accompanied - and probably caused - by a rapid Ca 2+ influx inside the schistosome. Drug created on June 13, 2005 13:24 / Updated on April 07, 2021 04:45, Accelerate your drug discovery research with our fully connected ADMET dataset, With our commercial data, access important information on, Our Blackbox Warnings cover Risks, Contraindications, and Adverse Effects, Reduce medical errors & improve treatment outcomes with our adverse effects data. Tablet. Praziquantel is the drug of choice for the treatment of all forms of schistosomiasis. Interactions. Praziquantel is the drug of choice for treating cestode and trematode infections in humans. 18 Praziquantel administration after fenbendazole administration has also be used successfully to treat peritoneal larval cestodiasis. bloody diarrhea. History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g., active hepatitis, renal disease, tuberculosis, heart disease. Drug: Praziquantel Praziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours. Newborn examined by study pediatrician at 28 days of life. All women will be 18 or older and otherwise healthy. For the treatment of infections due to all species of schistosoma. Praziquantel is given on and off label and by mouth or injection to treat various internal parasites. 25 However, optimal protocols are unknown and praziquantel is not labeled for these … DMID Protocol Number: 06-0039") for a previous pregnancy. QC Ortigas … Department Of State Health Services, Pharmacy Branch, Doenhoff MJ, Cioli D, Utzinger J: Praziquantel: mechanisms of action, resistance and new derivatives for schistosomiasis. It also paralyzes the parasites, causing them to release their hold on the blood vessel walls so the body can remove them naturally.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. It prevents newly hatched insect larvae (worms) from growing or multiplying in your body. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288872. Information provided by (Responsible Party): The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized or broken down differently when women are pregnant versus not pregnant. ], Early Pregnancy Cohort only: number of subjects experiencing a spontaneous abortion and number of stillbirths reported after drug administration; and live birth rate among pregnant subjects. ], Toxicity to maternal bone marrow, kidney, and liver will be assessed by measurement of complete blood count, blood urea nitrogen (BUN) and creatinine, and liver function tests (AST, ALT, and bilirubin). If pregnant, fetus has congenital anomaly determined by ultrasound or is determined to be nonviable e.g., blighted ovum. For lactating postpartum subjects: milk supply suspected to be marginal so that 24 hour interruption of nursing likely to lead to inability to restart breast feeding, evidence of breast infection, or history of breast surgery. 2 For these indications, ivermectin has been … Regular use of a medication for a chronic medical condition. It increases the cell permeability to Ca in schistosomes, causing strong contractions and paralysis of worm musculature leading to detachment of suckers from the blood vessel walls and to dislodgement. National Institute of Allergy and Infectious Diseases (NIAID). The overall aims of this study are to see if there are differences in PZQ PK and safety during pregnancy compared to post partum, to describe the kinetics of breast milk transfer of PZQ and to estimate the dose of PZQ received by a nursing infant whose mother is treated with PZQ. Researchers will study how PZQ is broken down among 15 women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women nonpregnant women who are producing breast milk. Praziquantel effects the permeability of the cell membrane resulting in the contraction of schistosomes. Back to top. PZQ is used to treat schistosomiasis (worm infection). 1 It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock. If pregnant, with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of pre-maturity such as duplicate uterus, uterine septum. Praziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours. Talk to your doctor about the risks of using praziquantel to treat your condition. Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies. In particular: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. For general information, Learn About Clinical Studies. The drug further causes vacuolization and disintegration of the schistosome tegument. Mercury Drug Stores with Diabetes Care Corner. Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Effectiveness then increases again until it is once again fully effective at 6-7 weeks. Glutathione S-transferase (GST), an essential detoxification enzyme in parasitic helminths, is a major vaccine target and a drug target against schistosomiasis. The therapeutic uses of this drug have been recorded against the following parasitic diseases. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Praziquantel (Biltricide) Uses Trematode (Fluke) Infections Schistosomiasis. Patient participation for mother/infant pair is about 9 months. Morphological alterations are another early effect of praziquantel. 2006 Sep-Oct;63(5):381-5. The metabolism of Praziquantel can be increased when combined with Albendazole. Mercury Drug reserves the right to deny any request for cancellation which is made after the given period. All subjects will be hospitalized overnight for intensive blood sampling and for monitoring for adverse events. In the case of acute medical conditions, such as urinary tract infection, pneumonia, or febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness). Results will change however, when somebody goes to market against Kusuri with a knockoff of the same compound but generic dosing instructions. The drug is effective, cheap and has few side effects. Makati City Bel-Air Hercules. Study procedures will include a 24 hour hospital stay following administration of PZQ, blood, stool and urine samples, ultrasound if pregnant, and physical exams of mother and baby. The pregnant women must: have a singleton pregnancy, be carrying a fetus without evidence of anomaly by ultrasound. Mandaluyong City Shangri-La Plaza. It works by killing the parasites. The metabolism of Praziquantel can be decreased when combined with Acyclovir. The drug further causes vacuolization and disintegration of the schistosome tegument. Praziquantel SDS Safety Data Sheet for Praziquantel 500022. Lactating nonpregnant: 5-7 months postpartum inclusive (up to 7 months and 31 days) with negative pregnancy test. Researchers propose to conduct a phase I study of the pharmacokinetics (PK) and safety of PZQ for the treatment of Schistosomiasis (S.) japonicum among pregnant and lactating women living in the province of Leyte, The Philippines. Praziquantelis a systemic anthelmintic used primarily to treat worm infections.It is currently the most effective drug forthe treatment of schistosomiasis.Originally developed for veterinary applications, for humans it is a lowcost, effective drug with mild side effects.It is most often taken orally in tablet form.The drug name's etymology is p(y)razi(ne),one of its components (from German Pyrazin, blend of Pyridin,pyridine and Azin, azine) + qu(inoline) + ant(h)el(mintic) (AmericanHeritage Dictionary). All studies will contribute to a meta-analysis of preferred praziquantel dosage by species and region. For less clear cases, we will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. The serum concentration of Praziquantel can be increased when it is combined with Abametapir. Woman has been enrolled into this study or its companion study ("S. japonicum and pregnancy outcomes: A Randomized, Double Blind, Placebo Controlled Trial (RCT). chest pain or discomfort. Acta Pol Pharm. Here’s a Praziquantel that works every time. Without treatment, these women accrue known morbidities identified among non-pregnant subjects including hepatic fibrosis, under-nutrition, and anemia. Eur J Clin Pharmacol. Asked by Wiki User. [, Ridtitid W, Wongnawa M, Mahatthanatrakul W, Punyo J, Sunbhanich M: Rifampin markedly decreases plasma concentrations of praziquantel in healthy volunteers. Praziquantel is used to treat infections caused by Schistosoma worms, which enter the body through skin that has come into contact with contaminated water. Present to a study midwife or health center. Praziquantel effects the permeability of the cell membrane resulting in the contraction of schistosomes. Genetic and Rare Diseases Information Center, 5U01AI066050-07 ( U.S. NIH Grant/Contract ), U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Choosing to participate in a study is an important personal decision. Forms available from special-order manufacturers include: tablet. The metabolism of Praziquantel can be increased when combined with Adalimumab. [, Godawska-Matysik A, Kiec-Kononowicz K: Biotransformation of praziquantel by human cytochrome p450 3A4 (CYP 3A4). The number of infants with congenital anomalies [ Time Frame: Newborn examined by the midwife (or pediatrician if in hospital) at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. It should not be used for worm infections of the eye. Praziquantel is for use in adults and children who are at least 1 year old. Please remove one or more studies before adding more. Ability to provide informed consent to participate. BILTRICIDE (praziquantel) is 2-(cyclohexylcarbonyl)-1,2,3,6,7, 11b-hexahydro-4H-pyrazino [2, 1-a] isoquinolin-4-one with the molecular formula; C. 19 H 24 N 2 O 2 Reduced hepatic metabolism of praziquantel results in higher and sustained plasma concentrations of unmetabolized drug in patients with liver impairment; monitor for adverse reactions when administering the recommended dose to patients with hepatosplenic schistosomiasis who have moderate or severe liver impairment (Child-Pugh Class B or C) An increased calcium influx may play an important role. This information should not be interpreted without the help of a healthcare provider. The drug further causes vacuolization and disintegration of the schistosome tegument. Does mercury drugs in the Philippines sell Praziquantel drugs? The biological profile of this drug against various helminth infections in humans has been extensively reviewed [1,26–30,40,74,75]. [ Time Frame: Women will be observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time. The action of praziquantel is limited very specifically to trematodes and cestodes; nematodes (including filariae) are not affected. Talk with your doctor and family members or friends about deciding to join a study. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. [ Time Frame: Assessed for the presence of pre-eclampsia at both the 22 and 32 week visits. The metabolism of Praziquantel can be decreased when combined with Acalabrutinib. Epub 2003 Aug 12. Praziquantel is one of the anthelmintics with activity against the trematodes that can be associated with gastrointestinal disease (Alaria spp., N. salmincola, H. americana, P. fastosum). The worms are then either completely destroyed in the intestine or passed in the stool. The study population will consist of S. japonicum infected women in study villages or at the Municipal Health Centers. It is taken by mouth. Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other reason, or refuses to provide informed consent. Check with your doctor immediately if any of the following side effects occur while taking praziquantel: Incidence not known. ], Subjects will be observed in hospital for adverse events/serious adverse events (AE/SAEs). Praziquantel is an anthelmintic used in most schistosome and many cestode infestations. It is indicated for use in non-lactating sheep as a single oral dose of 3.75 mg/kg bw. [ Time Frame: Up to 24 hours after the first dose of PZQ ], Early Pregnancy Cohort only: Assessed for the presence of pre-eclampsia. Subjects ingesting grapefruit juice during the previous week. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. A total dose of 60 mg/kg of study medication will be provided in 2 split doses over 3 hours as this has been shown to substantially reduce drug side effects. [ Time Frame: Up to 9 months from enrollment ]. Late pregnancy cohort: pregnant, between 30-36 weeks gestation. Curr Opin Infect Dis. The metabolism of Praziquantel can be decreased when combined with Acetaminophen. The absence of an interaction does not necessarily mean no interactions exist. An anthelmintic used in most schistosome and many cestode infestations. Praziquantel is an anthelmintic used in both human and veterinary medicine. Do not use in pets that are allergic to it, in puppies less than 3 weeks old, or kittens less than 6 weeks old. These morphological alterations are accompanied by an increased exposure of schistosome antigens at the parasite surface. Praziquantel (PZQ) is the drug of choice for treating infection with worms from the genus Schistosoma. 2008 Dec;21(6):659-67. doi: 10.1097/QCO.0b013e328318978f. The metabolism of Acenocoumarol can be decreased when combined with Praziquantel.  (Clinical Trial), Praziquantel Pharmacokinetics in Pregnancy and During Lactation, 18 Years to 99 Years   (Adult, Older Adult), Research Institute for Tropical Medicine - Health Compound, Muntinlupa City, National Capital Region, Philippines, 1781, Praziquantal, Schistosomiasis, pregnant women, Philippines, Comparison of PZQ and 4-hydroxy PZQ PK parameters in pregnant and nonpregnant lactating subjects, central tendency and distribution (Cmax, Tmax, t ½, AUC, CL/F and Vd/F). The serum concentration of Praziquantel can be increased when it is combined with Abiraterone. Listing a study does not mean it has been evaluated by the U.S. Federal Government. This worm enters the body while eating contaminated fish. The metabolism of Agomelatine can be decreased when combined with Praziquantel. Metro Manila. Praziquantel is used for the treatment of schistosomiasis (bilharziasis) caused by all Schistosoma species pathogenic to humans. Wiki User Answered 2010-10-30 13:48:24. no. Praziquantel (PZQ), sold under the brandname Biltricide among others, is a medication used to treat a number of types of parasitic worm infections in mammals, birds, amphibians, reptiles, and fish. (praziquantel) MM/14 DESCRIPTION BILTRICIDE ® (praziquantel) is a trematodicide provided in tablet form for the oral treatment of schistosome infections and infections due to liver fluke. Participant is otherwise healthy as determined by history, physical exam, ultrasound (if pregnant) and laboratory assessment, with the exception of laboratory values cited in Exclusion Criteria. Generic drug Praziquantel available with manufacturer details. [. In humans specifically, it is used to treat schistosomiasis, clonorchiasis, opisthorchiasis, tapeworm infections, cysticercosis, hydatid disease, and other fluke infections. The usual practice is to wait until after mothers have finished pregnancy and breast feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3 hours. Clin Pharmacol Ther. Combined use of two antiparasitic drugs may improve clearance of brain parasites. Subjects receiving during the previous month any of the following drugs which may interact with praziquantel (PZQ) bioavailability, metabolism and/or elimination: carbamazepine, chloroquine, cimetidine, dexamethasone, erythromycin, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifampin, or any protease inhibitor or non-nucleoside reverse transcriptase inhibitor. An interesting quirk of praziquantel is that it is relatively ineffective against juvenile schistosomes. ], Pregnant women only: newborn congenital anomalies. Read our, ClinicalTrials.gov Identifier: NCT01288872, Interventional It is also used to treat clonorchiasis infection caused by the Chinese or Oriental liver fluke (Clonorchis sinensis) or opisthorchiasis infection caused by the Southeast Asian liver fluke (Opisthorchis viverrini). If pregnant, with myoma on ultrasound that are sub-mucosal OR women with myoma that are in any location and greater than 5 cm in size. Praziquantel may also be used for purposes not listed in this medication guide. There can be variation in the licensing of different medicines containing the same drug.

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