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Nitazoxanide

    Brands

    DEA Class; Rx

    Common Brand Names; Alinia

    • Antiparasitic Agents

    Oral synthetic antiprotozoal agent for treatment of cryptosporidiosis or giardiasis caused by Cryptosporidium parvum or Giardia lamblia, respectively; is the first drug specifically approved for treating cryptosporidiosis; also effective in treating diarrhea due to other protozoa such as Giardia duodenalis, G. intestinalis and Entamoeba histolytica.

    Indicated for the treatment of infectious diarrhea and gastroenteritis, including, amebiasis, ascariasis (roundworm infection), cryptosporidiosis, cystoisosporiasis, giardiasis, microsporidiosis, and rotavirus infection.

    For the treatment of pseudomembranous colitis due to C. difficile infection.
    For Helicobacter pylori (H. pylori) eradication.

    Hypersensitivity

    • Headache (1%)
    • Abdominal pain (8%)
    • Diarrhea (2%)
    • Nausea (3%)
    • Chromaturia (2%)
    • Vomiting (1%)
    • Increased ALT
    • Anorexia
    • Appetite increased
    • Creatinine increased
    • Diaphoresis
    • Dizziness
    • Eye discoloration (pale yellow)
    • Fever
    • Flatulence
    • Infection
    • Malaise
    • Pruritus
    • Thinitis
    • Salivary glands enlarged
    • Urine discoloration

    Safety and efficacy not established in HIV+ or immunodeficient patients

    Effects in hepatic/renal impairment unknown; use caution

    Safety and efficacy of suspension in children <1 year not established

    Safety and efficacy of tablets in children <12 years not established

    No data with pregnant women to inform of drug-associated risk

    Development and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

    Adults

    1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.

    Geriatric

    1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.

    Adolescents

    1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label.

    Children

    12 years: 1,000 mg/day PO.
    4 to 11 years: 400 mg/day PO.
    1 to 3 years: 200 mg/day PO.

    Infants

    Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Nitazoxanide 

    tablet

    • 500mg

    oral suspension

    • 100mg/5mL