Dosing and uses of Alinia (nitazoxanide)
Adult dosage forms and strengths
tablet
- 500mg
oral suspension
- 100mg/5mL
Diarrhea Caused by Cryptosporidium Parvum or Giardia Lamblia
500 mg PO q12hr x 3 days
Amebiasis (Orphan)
Treatment for intestinal amebiasis
Orphan indication sponsor
- Romark Laboratories, L.C.; 6200 Courtney Campbell Causeway, Suite 880; Tampa, FL 33607
Pediatric dosage forms and strengths
tablet
- 500mg
oral suspension
- 100mg/5mL
Diarrhea Caused by Cryptosporidium Parvum or Giardia Lamblia
<1 year: Safety & efficacy not established
1-3 years: 5 mL (100 mg) PO q12hr x 3 days
4-11 years: 10 mL (200 mg) PO q12hr x 3 days
≥12 years: 500 mg PO q12hr x 3 days
Alinia (nitazoxanide) adverse (side) effects
1-10%
Headache (1%)
Abdominal pain (8%)
Diarrhea (2%)
Nausea (3%)
Chromaturia (2%)
Vomiting (1%)
<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
Postmarketing Reports
Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease
Nervous System disorders: dizziness
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: rash, urticariaL
Warnings
Contraindications
Hypersensitivity
Cautions
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
Drug interaction overview
- Tizoxanide (active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%)
- Monitor for adverse reactions if nitazoxanide is coadministered with other highly protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (eg, warfarin)
- The prescribing information recommends avoiding concurrent warfarin use
Pregnancy and lactation
Pregnancy: No data with pregnant women to inform of drug-associated risk; No teratogenicity or fetotoxicity observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at maximum recommended human dose of 500 mg twice daily based on body surface area (BSA)
Lactation: 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
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Alinia (nitazoxanide)
Mechanism of action
Inhibits growth of sporozoites and oocysts of Cryptosporidium and trophozoites of Giardia
Interferes with pyruvate:ferredoxin oxidoreductase (PFOR), essential to anaerobic energy metabolism
Pharmacokinetics
Protein Bound: >99.9%
Metabolism: hydrolysis & glucuronidation
Metabolites: Tizoxanide, tizoxanide glucuronide (100% conversion)
Excretion: Urine, bile, feces
Peak PlasmaTime: 1-4 hr
Peak plasma concentration: 3 mcg/mL
AUC: 12-19 mcg.hr/mL
Administration
Oral Administration
Take with food
