Adult Dosing

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum

• 500 mg tablet PO with food q12 hrs x 3 days; alt: 25 mL suspension (500 mg) PO q12 hrs with food x 3 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients <1 yr of age have not been established

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum

• 1-3 yrs: 5 ml suspension (100 mg) PO with food q12 hrs x 3 days
• 4-11 yrs: 10 ml suspension (200 mg) PO with food q12 hrs X 3 days
• 12 yrs: 500 mg PO with food q12 hrs x 3 days; alt: 25 mL suspension (500 mg) PO q12 hrs with food x 3 days

Note:

• Tablets should not be used in pediatric patients <11 years; oral suspension is recommended for these patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; use with caution

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; use with caution

• Use cautiously in patients with hepatic and biliary disease, in those with renal disease, and in patients with combined renal and hepatic disease
• Dose should be taken with food
• Nitazoxanide has not been studied in HIV-infected or immunodeficient patients for the treatment of diarrhea caused by Giardia lamblia
• Nitazoxanide has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients

Caution: Use cautiously in

• Diabetes mellitus

Pregnancy Category:B

Breastfeeding: Manufacturer advises caution when administered to a nursing woman.

• GI: Abdominal pain, diarrhea, vomiting, nausea
• CNS: Headache
• GU: Urine discoloration
• EENT: Ocular discoloration

• Antiprotozoal agent; interferes with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism in Giardia lamblia and Cryptosporidium parvum
• Metabolized in liver by glucuronidation; CYP450: Unknown
• Nitazoxanide (prodrug) is rapidly hydrolyzed to its active metabolite, tizoxanide (desacetyl-nitazoxanide)
• Excretion: Urine, bile and feces
• Half-life: Unknown

US Trade Name(s)

• Alinia

US Availability

Alinia

• TABS: 500 mg
• SUSP: 100 mg/5 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antiparasitics

Amebicides

Infectious Disease

Antiparasitics

Amebicides

Pricing data from www.DrugStore.com in U.S.A.

• Alinia 500 MG TABS [Bottle] (ROMARK PHARMACEUTICALS)
  60 mg = $1425.99
  180 mg = $4006.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Alinia 500 MG Oral Tablet

Ingredient(s): Nitazoxanide

Imprint: ALINIA;500

Color(s): Yellow

Shape: Round

Size (mm): 13.00

Score: 1

Inactive Ingredient(s): starch, corn / hypromellose / sucrose / sodium starch glycolate type a potato / talc / magnesium stearate / lecithin, soybean / polyvinyl alcohol / xanthan gum / titanium dioxide / d&c yellow no. 10 / fd&c yellow no. 6 / fd&c blue no. 2

Drug Label Author:
Romark Laboratories, L.C.

DEA Schedule:
Non-Scheduled