Alinia (nitazoxanide)

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).

Giardia lamblia:

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 rate.

Cryptosporidium parvum:

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
• Diarrhea
• Vomiting
• Headache
• Flatulence
• Fever
• Eye discoloration
• Rhinitis
• Discolored urine

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; 184:381-4.

For additional information on Alinia (nitazoxanide), please contact Romark Laboratories