Nitazoxanide
Nitazoxanide Prescribing Information
Diarrhea caused by
Giardia lamblia
or Cryptosporidium parvum:
Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by
Giardia lamblia
or Cryptosporidium parvum
.Limitations of Use
Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by
Cryptosporidium parvum
in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].
- Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger (2.1).
- Dosage for treatment of diarrhea caused by G. lambliaorC. parvum(2.1):
Age | Dosage | Duration |
| 12 years and older | One nitazoxanide tablet (500 mg nitazoxanide) every 12 hours with food | 3 days |
Nitazoxanide Tablets: 500 mg (3.1)
Pediatric Patients: Safety and efficacy of ALINIA
®
for Oral Suspension in pediatric patients less than one year of age has not been studied (8.4).Hypersensitivity (4.1)
The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available