ALINIA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALINIA (ALINIA).
Nitazoxanide is a thiazolide antiparasitic agent that inhibits the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction, which is essential for anaerobic energy metabolism in parasites.
| Metabolism | Nitazoxanide is rapidly hydrolyzed by plasma esterases to its active metabolite, tizoxanide. Tizoxanide is then conjugated via glucuronidation. CYP450 enzymes are not significantly involved. |
| Excretion | Fecal (75-85% as tizoxanide), renal (5-10% as tizoxanide and conjugates), biliary (minor). |
| Half-life | Terminal half-life of tizoxanide is approximately 1.5-2 hours in patients with normal renal function; clinical context: short half-life requires twice-daily dosing. |
| Protein binding | Tizoxanide: >99.9% bound (mainly to albumin). |
| Volume of Distribution | Apparent Vd: 0.6-0.7 L/kg (tizoxanide), indicating distribution into total body water. |
| Bioavailability | Oral: 70-80% for tizoxanide (active metabolite) following oral administration of nitazoxanide. |
| Onset of Action | Oral: within 1-2 hours post-dose; clinical effect within 24-72 hours for cryptosporidiosis and giardiasis. |
| Duration of Action | Duration of therapeutic activity approximately 12 hours based on dosing interval (every 12 hours) for 3 days. |
500 mg orally twice daily for 3 days, with food.
| Dosage form | TABLET |
| Renal impairment | No adjustment required for mild to moderate renal impairment. Not studied in ESRD; use with caution. |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Age 1-3 years: 200 mg (5 mL suspension) orally twice daily for 3 days. Age 4-11 years: 200 mg (5 mL) or 5 mL of 100 mg/5 mL suspension orally twice daily for 3 days. Age 12 years and older: 500 mg (tablet or 25 mL suspension) orally twice daily for 3 days. |
| Geriatric use | No specific dose adjustment recommended; use standard adult dosing. Monitor renal function as elderly may have decreased creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALINIA (ALINIA).
| Breastfeeding | Excreted in breast milk in animal studies; unknown M/P ratio in humans. Use caution in nursing mothers, especially with infants under 6 months or with impaired renal function. |
| Teratogenic Risk | Pregnancy Category B. Animal studies show no fetal risk, but no adequate human studies in pregnant women. First trimester: limited data, use only if clearly needed. Second and third trimesters: no known fetal harm, but caution advised. |
| Fetal Monitoring |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
["Hypersensitivity to nitazoxanide or any component of the formulation."]
| Precautions | ["May cause gastrointestinal adverse reactions including abdominal pain, diarrhea, and nausea.","Caution in patients with biliary tract disease or hepatic impairment."] |
| Food/Dietary | Take with food to maximize absorption. No specific dietary restrictions, but avoid alcohol due to potential hepatotoxicity. |
| Clinical Pearls | ALINIA (nitazoxanide) is used primarily for diarrhea caused by Cryptosporidium parvum or Giardia lamblia in immunocompetent patients. For Cryptosporidium in immunocompromised (e.g., HIV) patients, efficacy is limited; consider alternative. Administer with food to enhance absorption. Monitor for hepatotoxicity in pre-existing liver disease. |
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| No specific monitoring required for pregnancy; general fetal growth monitoring if used during gestation. |
| Fertility Effects | No evidence of impaired fertility in animal studies; no human data. |
| Patient Advice | Take this medication with food to improve absorption. · Complete the full course even if symptoms improve. · May cause discolored urine (bright yellow) – harmless. · Report signs of liver problems: yellow skin/eyes, dark urine, severe abdominal pain. · Avoid alcohol during treatment to reduce liver strain. |