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Indications*

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 or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Important Safety Information

  • ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

Indications*

ALINIA® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older).
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be

Important Safety Information

Clinical studies 2018-05-08T10:23:22+00:00

Alinia® is the only FDA-approved product for treating diarrhea caused by Cryptosporidium parvum and Giardia lamblia in patients 1 year of age and older.

Alinia demonstrated efficacy against diarrhea caused by Cryptosporidium parvum and Giardia lamblia. % (No. of Successes/Total)
Summary of Alinia Clinical Study Outcomes
% (Number of Successes/Total)

per protocol analysis

Click to View Detailed Information about Alinia Clinical Studies

In a double-blind, controlled trial conducted in Egypt in adults and adolescents with diarrhea with or without enteric symptoms (e.g., abdominal pain/cramps, nausea, vomiting) caused by Cryptosporidium parvum, a three-day course of treatment with Alinia Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. A third group of patients received open-label Alinia for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. Clinical response was evaluated 4 to 7 days following the end of treatment. A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Cryptosporidium 1

Adult and Adolescent Patients with Diarrhea Caused by Cryptosporidium parvum 

Clinical Response Rates 4 to 7 Days Post-therapy

% (Number of Successes/Total)

* Includes all patients randomized with Cryptosporidium parvum as the sole pathogen. Patients failing to complete the study were treated as failures.
Clinical response rates statistically significantly higher when compared to placebo.
§ The 95% confidence interval of the difference in response rates for the tablet and suspension is (-10%, 28%).

In a second double-blind, placebo-controlled trial of nitazoxanide tablets conducted in Egypt (Cryptosporidium 2) in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal cramps, epigastric pain) caused by Cryptosporidium parvum as the sole pathogen, clinical and parasitological response rates showed a similar trend to the first study. Clinical response rates, evaluated 2 to 6 days following the end of treatment, were 71% (15/21) in the nitazoxanide group and 42.9% (9/21) in the placebo group.

Some patients with ‘well’ clinical responses had Cryptosporidium parvum oocysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

In two double-blind, controlled trials in pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, colic, left iliac fossa tenderness) caused by Cryptosporidium parvum, a three-day course of treatment with nitazoxanide (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared with a placebo. One study was conducted in Egypt in outpatients ages 1 through 11 years with diarrhea caused by C. parvum. Another study was conducted in Zambia in malnourished pediatric patients admitted to the hospital with diarrhea caused by C. parvum. Clinical response was evaluated 3 to 7 days post-therapy with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Pediatric Patients with Diarrhea Caused by Cryptosporidium parvum
Clinical Response Rates 3 to 7 Days Post-therapy, Intent-to-Treat Analyses
% (Number of Successes/Total)

* Clinical response rates statistically significantly higher compared to placebo.
60% considered severely underweight, 19% moderately underweight, 17% mild underweight.

Some patients with ‘well’ clinical responses had Cryptosporidium parvum oocysts in their stool samples 3 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

In a double-blind, controlled trial (Study 1) conducted in Peru and Egypt in adults and adolescents with diarrhea with one or more enteric symptoms (e.g., abdominal pain, nausea, vomiting, fever, abdominal distention, loss of appetite, flatulence) caused by Giardia lamblia, a three-day course of treatment with Alinia Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. A third group of patients received open-label Alinia for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. A second double-blind, controlled trial (Study 2) conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal tenderness, abdominal cramps, abdominal distention, fever, bloody stool) caused by Giardia lamblia compared Alinia Tablets administered 500 mg BID for 3 days to a placebo tablet. For both of these studies, clinical response was evaluated 4 to 7 days following the end of treatment. A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Adult and Adolescent Patients with Diarrhea Caused by Giardia lamblia
Clinical Response Rates* 4 to 7 Days Post-therapy
% (Number of Successes/Total)

* Includes all patients randomized with Giardia lamblia as the sole pathogen. Patients failing to complete the studies were treated as failures.

Clinical response rates statistically significantly higher when compared to placebo.
§ The 95% confidence interval of the difference in response rates for the tablet and suspension is (-14%, 17%).

Some patients with ‘well’ clinical responses had Giardia lamblia cysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

In a randomized, controlled trial conducted in Peru in 110 pediatric patients with diarrhea with or without enteric symptoms (e.g., abdominal distension, right iliac fossa tenderness) caused by Giardia lamblia, a three-day course of treatment with nitazoxanide (100 mg BID in pediatric patients ages 24-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared to a five-day course of treatment with metronidazole (125 mg BID in pediatric patients ages 2 through 5 years, 250 mg BID in pediatric patients ages 6 through 11 years). Clinical response was evaluated 7 to 10 days following initiation of treatment with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical cure rates were obtained:

Study 3

Pediatric Patients with Diarrhea Caused by Giardia lamblia
Clinical Response Rates 7 to 10 Days Following Initiation of Therapy
Intent-to-Treat and Per Protocol Analyses
% (Number of Successes/Total)

Intent-to-treat analysis includes all patients randomized with patients not completing the study treated as failures.
Per protocol analysis includes only patients who took all of their medication and completed the study. Seven patients in each treatment group missed at least one dose of medication and one in the metronidazole treatment group was lost to follow-up.
§ The 95% Confidence Interval on the difference in response rates (nitazoxanide-metronidazole) was (-9%-20%) for intent-to-treat and (-8%-21%) for per protocol.

Some patients with ‘well’ clinical responses had Giardia lamblia cysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

A double-blind, placebo-controlled trial did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia. In this study, the pediatric patients received a three day course of nitazoxanide suspension (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) and were evaluated for response four days after the end of treatment.

Indications*

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 or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Important Safety Information

  • ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
  • The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia and nausea.
  • Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).
  • ALINIA tablets and ALINIA for Oral Suspension should be taken with food.
  • Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.

*Please read the Full Prescribing Information.

To report suspected adverse reactions, contact Romark at 1-813-282-8544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Alinia is a registered trademark of Romark, L.C.

Intended only for Healthcare Professionals of the United States of America. ©2017 Romark, L.C., Tampa, Florida 33607-8416

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