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