ALINIA SUMMARY
Alinia Tablets and Alinia for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal agent for oral administration. Nitazoxanide is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water.
Alinia for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by
Giardia lamblia.
Alinia for Oral Suspension is indicated for patients 1 through 11 years of age for the treatment of diarrhea caused by
Cryptosporidium parvum.
Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by
Cryptosporidium parvum
in HIV-infected or immunodeficient patients (see CLINICAL STUDIES).
The safety and effectiveness of Alinia for Oral Suspension or Alinia Tablets for the treatment of diarrhea caused by
Cryptosporidium parvum
in patients 12 years of age and older have not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Alinia (Nitazoxanide)
Nitazoxanide vs. probiotics for the treatment of acute rotavirus diarrhea in children: a randomized, single-blind, controlled trial in Bolivian children. [2009.07]
BACKGROUND: In previous studies, nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing the duration of diarrhea in comparison to placebo. We designed a randomized, single-blind, controlled trial in order to assess the effectiveness of nitazoxanide and probiotics in comparison with a control group... CONCLUSIONS: Treatment with nitazoxanide and probiotics is effective in the management of children with acute rotavirus diarrhea. Small differences in favor of nitazoxanide were found in comparison with probiotics. Nitazoxanide is an important treatment option for rotavirus diarrhea.
Effects of nitazoxanide on pharmacokinetics and pharmacodynamics of a single dose of warfarin. [2009.05.01]
PURPOSE: The effects of nitazoxanide on warfarin pharmacokinetics and pharmacodynamics are examined... CONCLUSION: Coadministration of nitazoxanide twice daily for six days did not affect the pharmacokinetic or pharmacodynamic properties of a single 25-mg dose of warfarin sodium. Administration of a single dose of warfarin or combined administration of a single dose of warfarin and multiple doses of nitazoxanide appeared safe and well tolerated.
Effect of nitazoxanide on cryptosporidiosis in experimentally infected neonatal dairy calves. [2009.04]
Cryptosporidium is a zoonotic protozoan that is most often diagnosed in association with diarrhea in 1- to 3-wk-old dairy calves... Treating calves with NTZ reduced the duration of oocyst shedding and improved fecal consistency.
Evaluation of nitazoxanide and oxfendazole efficacy against cystic echinococcosis in naturally infected sheep. [2009.03]
Cystic echinococosis (CE) is a public health problem caused by Echinococcus granulosus...
Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin. [2009.03]
BACKGROUND & AIMS: Sustained virologic response (SVR) rates of 50%-60% have been achieved in patients with chronic hepatitis C genotype 4 treated with peginterferon plus ribavirin. The safety and efficacy of nitazoxanide plus peginterferon alfa-2a, with or without ribavirin, were evaluated in a randomized controlled trial at 2 centers in Egypt... CONCLUSIONS: The combination of nitazoxanide, peginterferon alfa-2a, and ribavirin increased the percentages of patients with RVR and SVR, compared with patients given peginterferon plus ribavirin, without an increase in adverse events.
Clinical Trials Related to Alinia (Nitazoxanide)
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C [Active, not recruiting]
The purpose of this study is to evaluate the safety and efficacy of
nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens
compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C
genotype 4. The study will also evaluate the effect of the studied treatment regimens on end
of treatment virologic response, ALT normalization and safety parameters.
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus [Completed]
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be
clinically important in time of hospitalization and reduction of duration of diarrhea
secondary to rotavirus?
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients [Recruiting]
The purpose of this study is to determine if nitazoxanide in combination with peginterferon
alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in
treatment-naive patients.
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children [Completed]
A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis [Active, not recruiting]
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