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.
|