Jane S. Ricciuti, RPh, MS

Disclosures

December 27, 2002

In This Article

Antibiotic Agents

Alinia
(nitazoxanide) Oral Suspension

Manufacturer: Romark Laboratories, LC

Drug Approval Classification: Original New Drug Application (Approval Date: 11/22/02)

Indication: Alinia Oral Suspension is indicated for the treatment of diarrhea caused by C parvum and G lamblia in pediatric patients 1 through 11 years of age. Safety and effectiveness of Alinia have not been studied in HIV-positive patients or patients with immunodeficiency, in pediatric patients younger than 1 year or older than 11 years, or adults.

Dosing: Alinia is dosed according to age:

Age 12-47 months: 5 mL (100 mg nitazoxanide) every 12 hours for 3 days

  • Age 4-11 years: 10 mL (200 mg nitazoxanide) every 12 hours for 3 days

  • The oral suspension should be taken with food.

    Alinia is a pink powder that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL in a 60-mL bottle.

    Clinical Summary: The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction that is essential to anaerobic energy metabolism.

    C parvum: Two double-blind, controlled studies in pediatric patients with diarrhea caused by C parvum were conducted. 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."

    In a 3-day course of treatment with Alinia 100 mg twice daily in pediatric patients aged 12-47 months, 56% of Alinia-treated patients responded compared with 23% of placebo-treated patients.

    In a 3-day course in pediatric patients aged 4 through 11 years who were administered 200 mg of Alinia twice daily, 88% of patients had positive responses to Alinia compared with 38% of patients who received placebo.

    G lamblia: In a single randomized, controlled study conducted in Peru in 110 pediatric patients with diarrhea caused by G lamblia, investigators evaluated a 3-day course of treatment with Alinia (100 mg twice daily in pediatric patients aged 24-47 months, 200 mg twice daily in pediatric patients aged 4 through 11 years) compared with a 5-day treatment course with metronidazole (125 mg twice daily in pediatric patients aged 2 through 5 years, 250 mg twice daily in pediatric patients aged 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."

    Alinia was marginally superior to metronidazole. Alinia response was 85% and metronidazole response was 80% in the intent-to-treat analysis.

    Adverse Effects: Adverse events in the placebo-controlled clinical trials were similar to those seen with placebo. They include: abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%), and headache (1.1%).

    Pharmacokinetics: Maximum plasma concentrations occur within 1 to 4 hours after oral administration. Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation.

    Reference

    Alinia (nitazoxanide) Oral Suspension labeling

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