Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Gastroenterology | Immunology | Pediatrics/Neonatology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Romark Laboratories
Approval Status: December 2002
Treatment Area: Diarrhea caused by Cryptosporidium and Giardia in children.
Alinia for Oral Suspension contains the active ingredient,
nitazoxanide (2-acetyloxy-N- (5-nitro-2-thiazolyl) benzamide), a
synthetic antiprotozoal agent for oral administration.
Alinia for Oral Suspension is indicated for the treatment of
diarrhea caused by Cryptosporidium parvum and Giardia lamblia
parasites in pediatric patients 1 through 11 years of age.
Alinia for Oral Suspension (100 mg/5mL) will be available in a
liquid suspension form. In addition, safety and effectiveness have
not been established in patients with immune deficiencies such as
patients with human immunodeficiency virus (HIV).
In a randomized, controlled study conducted in Peru in 110
pediatric patients with diarrhea caused by Giardia lamblia, a
three-day course of treatment with nitazoxanide (100 mg BID in
pediatric patients ages 24-47 months, 200 mg BID in pediatric
patients ages 4 through 11 years) was compared to a five-day course
of treatment with metronidazole (125 mg BID in pediatric patients
ages 2 through 5 years, 250 mg BID in pediatric patients ages 6
through 11 years). Clinical response was evaluated 7 to 10 days
following initiation of treatment with a ‘well’ response defined as
‘no symptoms, no watery stools and no more than 2 soft stools with
no hematochezia within the past 24 hours’ or ‘no symptoms and no
unformed stools within the past 48 hours.’ The following clinical
cure rates were obtained: Nitazoxanide (3 days) had a 90% (43/48)
response rate and Metronidazole (5 days) had a 83% (39/47) response
In two double-blind, controlled studies in pediatric patients
with diarrhea caused by Cryptosporidium parvum, a three-day course
of treatment with nitazoxanide (100 mg BID in pediatric patients
ages 12-47 months, 200 mg BID in pediatric patients ages 4 through
11 years) was compared with a placebo. One study was conducted in
Egypt in outpatients ages 1 through 11 years with diarrhea caused
by C. parvum. Another study was conducted in Zambia in malnourished
pediatric patients admitted to the hospital with diarrhea caused by
C. parvum. Clinical response was evaluated 3 to 7 days post-therapy
with a ‘well’ response defined as ‘no symptoms, no watery stools
and no more than 2 soft stools with no hematochezia within the past
24 hours’ or ‘no symptoms and no unformed stools within the past 48
hours.’ The results show a clinical response rate for nitazoxanide
of 88% (21/24) versus 38% (9/24) for placebo.
Adverse events associated with the use of Alinia (nitazoxanide)
may include (but are not limited to) the following:
- Abdominal pain
- Eye discoloration
- Discolored urine
Mechanism of Action
Following oral administration in humans, nitazoxanide is rapidly
hydrolyzed to an active metabolite, tizoxanide
(desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation,
primarily by glucuronidation.
The antiprotozoal activity of nitazoxanide is believed to be due
to interference with the pyruvate: ferredoxin oxidoreductase (PFOR)
enzyme-dependent electron transfer reaction, which is essential to
anaerobic energy metabolism. Studies have shown that the PFOR
enzyme from Giardia lamblia directly reduces nitazoxanide by
transfer of electrons in the absence of ferredoxin. The DNAderived
PFOR protein sequence of Cryptosporidium parvum appears to be
similar to that of Giardia lamblia.
Amadi B, Mwiya M, Musuku J, Watuka A, Sianongo S, Ayoub
A, Kelly P. Effect of nitazoxanide on morbidity and
mortality in Zambian children with cryptosporidiosis: a randomized
controlled trial.Lancet. 2002; 360:1375-80.
Gilles HM, Hoffman PS. Treatment of intestinal
parasitic infections: a review of nitazoxanide. Trends in
Parasitology. 2002; 18:95-7.
Rossignol JF, Ayoub A, Ayers MS. Treatment of
Diarrhea Caused by Giardia intestinalis and Entamoeba histolytica
or E. dispar: A Randomized, Double-Blind, Placebo-Controlled Study
of Nitazoxanide. Journal of Infectious Diseases. 2001;