Alinia® is the only FDA-approved product for treating diarrhea caused by Cryptosporidium parvum and Giardia lamblia in patients 12 years of age and older.
Clinical Trial Data
In clinical trials for Alinia Tablets, patients were enrolled with diarrhea and with or without enteric symptoms, including:
Diarrhea
Nausea
Fever
Loss of Appetite
Abdominal pain/cramps
Vomiting
Bloating
Gas
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
Alinia demonstrated efficacy against diarrhea caused by Cryptosporidium parvum and Giardia lamblia.1
% (Total)
Alinia (nitazoxanide) – Dosage and Administration
†Limitations of Use: Alinia Tablets and for Oral Suspension have 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 Tablets are round, yellow, film-coated tablets debossed with Alinia on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 12 and 30 tablets.
1 Alinia [prescribing information]. Tampa, FL: Romark, L.C.; April 2017.
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. ©2021 Romark, L.C., Tampa, Florida 33607-8416