Prazi-C

Prazi-C (praziquantel), aşağıdakilere bağlı enfeksiyonların tedavisi için endikedir: tüm şistozom türleri (örneğin, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni ve Şistozom hematobium) ve karaciğer parazitlerine bağlı enfeksiyonlar, Clonorchis sinensis / Opisthorchis viverrini (bu endikasyonun onayı, iki türün farklılaşmadığı çalışmalara dayanıyordu).

Şistozomiyaz tedavisi için önerilen doz: 4 saatten az olmayan ve 6 saatten fazla olmayan aralıklarla, bir günlük tedavi olarak günde üç kez 20 mg / kg vücut ağırlığı. Klonorkiazis ve opisthorchiasis için önerilen doz: bir günlük tedavi olarak günde üç kez 25 mg / kg vücut ağırlığı, 4 saatten az olmayan ve 6 saatten fazla olmayan aralıklarla. Tabletler yemek sırasında su ile yıkanmadan yıkanmalıdır. Tabletleri veya segmentlerini ağızda tutmak, öğürmeyi veya kusmayı teşvik edebilecek acı bir tat ortaya çıkarabilir.

Prazi-C (praziquantel), daha önce ilaca veya yardımcı maddelerden herhangi birine aşırı duyarlılık gösteren hastalarda kontrendikedir. Göz içindeki parazit yıkımı geri dönüşümsüz lezyonlara neden olabileceğinden, oküler sistiserkoz bu bileşikle tedavi edilmemelidir.

Rifampin gibi güçlü Sitokrom P450 (P450) indükleyicileri ile birlikte uygulama kontrendikedir, çünkü prazikuantelin terapötik olarak etkili kan seviyelerine ulaşılamayabilir (bkz ÖNLEMLER: İLAÇ ETKİLEŞİMLERİ). Şistozomiyaz için acil tedaviye ihtiyaç duyan rifampin alan hastalarda, şistozomiyaz için alternatif ajanlar düşünülmelidir. Bununla birlikte, praziquantel ile tedavi gerekliyse, praziquantel uygulanmadan 4 hafta önce rifampin kesilmelidir. Rifampin ile tedavi daha sonra praziquantel tedavisinin tamamlanmasından bir gün sonra yeniden başlatılabilir (bkz ÖNLEMLER: İLAÇ ETKİLEŞİMLERİ).

WARNINGS

Therapeutically effective levels of Prazi-C (praziquantel) may not be achieved when administered concomitantly with strong P450 inducers, such as rifampin (see CONTRAINDICATIONS).

PRECAUTIONS

General

Approximately 80% of a dose of praziquantel is excreted in the kidneys, almost exclusively ( > 99%) in the form of metabolites. Excretion might be delayed in patients with impaired renal function, but accumulation of unchanged drug would not be expected. Therefore, dose adjustment for renal impairment is not considered necessary. Nephrotoxic effects of praziquantel or its metabolites are not known.

Caution should be exercised in the administration of the usual recommended dose of praziquantel to hepatosplenic schistosomiasis patients with moderate to severe liver impairment (Child-Pugh class B and C). Reduced metabolism of praziquantel by the liver in these patients may lead to considerably higher and longer lasting plasma concentrations of unmetabolized praziquantel (See CLINICAL PHARMACOLOGY/Special Populations).

Minimal increases in liver enzymes have been reported in some patients.

Patients suffering from cardiac irregularities should be monitored during treatment.

As Prazi-C (praziquantel) can exacerbate central nervous system pathology due to schistosomiasis, as a general rule this drug should not be administered to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis.

When schistosomiasis or fluke infection is found to be associated with cerebral cysticercosis it is advised to hospitalize the patient for the duration of treatment.

Mutagenesis, Carcinogenesis

Mutagenic effects in Salmonella tests found by one laboratory have not been confirmed in the same tested strain by other laboratories. Long term carcinogenicity studies in rats and golden hamsters did not reveal any carcinogenic effect.

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to praziquantel. There are, however, no adequate and well-controlled studies in pregnant women. An increase of the abortion rate was found in rats at three times the single human therapeutic dose. While animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

Praziquantel appeared in the milk of nursing women at a concentration of about 1/4 that of maternal serum although it is not known whether a pharmacological effect is likely to occur in children. Women should not nurse on the day of Prazi-C (praziquantel) treatment and during the subsequent 72 hours.

Pediatric use

Safety in children under 4 years of age has not been established.

Geriatric use

Clinical studies of praziquantel did not include a sufficient number of subjects ages 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out.

This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, the risk of toxic reactions to this drug may be greater in these patients.

Adverse Events

In general Prazi-C (praziquantel) is very well tolerated. Side effects are usually mild and transient and do not require treatment. The following side effects were observed generally in order of severity: malaise, headache, dizziness, abdominal discomfort with or without nausea, rise in temperature and, rarely, urticaria. Such symptoms can, however, also result from the infection itself. Such side effects may be more frequent and/or serious in patients with a heavy worm burden.

Post Marketing Adverse Event Reports

Additional adverse events reported from worldwide post marketing experience and from publications with praziquantel include: abdominal pain, allergic reaction (generalized hypersensitivity) including polyserositis, anorexia, arrhythmia (including bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks), asthenia, bloody diarrhea, convulsion, eosinophilia, myalgia, pruritis, somnolence, vertigo and vomiting.