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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

Alinia Oral Suspention 2018-01-15T13:47:22+00:00

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

Clinical Trial Data

In clinical trials for Alinia for Oral Suspension, patients were enrolled with diarrhea and with or without enteric symptoms, including:

Abdominal distention
Colic

Vomiting
Nausea

Left/right iliac fossa tenderness

Alinia demonstrated efficacy against diarrhea with a “well” clinical response defined as:

  • No symptoms, no watery stools and no more than two soft stools with no hematochezia within the past 24 hours, or
  • No symptoms and no unformed stools within the past 48 hours

Diarrhea caused by Giardia lamblia in pediatric patients 1 through 11 years of age
Pediatric Patients with Diarrhea Caused by Giardia lamblia
Clinical Response Evaluated 7 to 10 Days after Treatment Initiation
% (Number of Successes/Total)

a ALINIA for Oral Suspension 100 mg BID (24-47 months) and 200 mg BID (ages 4-11 years) x 3 days, was compared to metronidazole 125 mg BID (ages 2-5 years) and 250 mg BID (ages 6-11 years) x 5 days.

b 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 1 dose of medication and 1 in the metronidazole treatment group was lost to follow-up.

Diarrhea caused by Giardia lamblia in adults and adolescents 12 years of age or older

Adult and Adolescent Patients with Diarrhea Caused by G. lamblia

Clinical Response Rates* 4 to 7 Days Post-therapy

% (Number of Successes/Total)

* Includes all patients randomized with G. 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 suspension is (17%).

Diarrhea caused by Cryptosporidium parvum in adults and adolescents 12 years of age or older

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%).

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.

Diarrhea caused by Cryptosporidium parvum in pediatric patients 1 through 11 years of age

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 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.

Alinia for Oral Suspension – Dosage and Administration

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

Please see the Full Prescribing Information for more information.

How Supplied and NDC Information

Alinia for Oral Suspension is a pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor.

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

Please verify that you are a U.S. Healthcare Professional. This information is intended for U.S. Healthcare Professionals.