Dosing & Uses
Dosage Forms & 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
Dosage Forms & 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
Dosing considerations
- A single tablet of this drug contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger; therefore, tablets should not be administered to pediatric patients 11 years of age or younger
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (9)
- axicabtagene ciloleucel
nitazoxanide, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
nitazoxanide will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.
- brexucabtagene autoleucel
nitazoxanide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
nitazoxanide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
nitazoxanide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
nitazoxanide, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- phenytoin
nitazoxanide, phenytoin. Either increases levels of the other by Mechanism: plasma protein binding competition. Avoid or Use Alternate Drug.
- tisagenlecleucel
nitazoxanide, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- valproic acid
nitazoxanide, valproic acid. Either increases levels of the other by Mechanism: plasma protein binding competition. Avoid or Use Alternate Drug.
Monitor Closely (11)
- acetazolamide
nitazoxanide, acetazolamide. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- acitretin
nitazoxanide, acitretin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Use Caution/Monitor.
- aspirin
nitazoxanide, aspirin. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- bumetanide
nitazoxanide, bumetanide. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- chlorthalidone
nitazoxanide, chlorthalidone. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- cisplatin
nitazoxanide, cisplatin. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- clindamycin
nitazoxanide, clindamycin. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- glipizide
nitazoxanide, glipizide. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- glyburide
nitazoxanide, glyburide. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- tacrolimus
nitazoxanide, tacrolimus. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
- vincristine
nitazoxanide, vincristine. Either increases levels of the other by Mechanism: plasma protein binding competition. Use Caution/Monitor.
Minor (14)
- dicloxacillin
nitazoxanide, dicloxacillin. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- diphenhydramine
nitazoxanide, diphenhydramine. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- fenoprofen
nitazoxanide, fenoprofen. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- indomethacin
nitazoxanide, indomethacin. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- meclofenamate
nitazoxanide, meclofenamate. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- mefenamic acid
nitazoxanide, mefenamic acid. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- naproxen
nitazoxanide, naproxen. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- ospemifene
nitazoxanide, ospemifene. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- piroxicam
nitazoxanide, piroxicam. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- spironolactone
nitazoxanide, spironolactone. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- sulfamethoxazole
nitazoxanide, sulfamethoxazole. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- sulindac
nitazoxanide, sulindac. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- tolbutamide
nitazoxanide, tolbutamide. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
- tolmetin
nitazoxanide, tolmetin. Either increases levels of the other by Mechanism: plasma protein binding competition. Minor/Significance Unknown.
Adverse 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 & 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
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
Preparation or oral suspension
Measure 48 mL of water for preparation of the 100 mg/5 mL suspension
Tap bottle until all powder flows freely
Add approximately one-half of 48 mL of water required for reconstitution and shake vigorously to suspend powder
Add remainder of water and again shake vigorously
Keep container tightly closed, and shake the suspension well before each administration
The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded
Oral Administration
Take with food
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Alinia oral - | 100 mg/5 mL suspension |  | |
| Alinia oral - | 500 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
nitazoxanide oral
NITAZOXANIDE - ORAL
(NYE-ta-ZOX-a-nide)
COMMON BRAND NAME(S): Alinia
USES: This medication is used to treat diarrhea caused by certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia).
HOW TO USE: Take this medication by mouth with food as directed by your doctor, usually every 12 hours for 3 days.If you are taking the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.Children 11 years old or younger should take the liquid form of nitazoxanide, but not the tablets. For children, the dosage is based on age.Antibiotics work best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals.Continue to take this medication for the full time prescribed, even if symptoms disappear after a few doses. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Headache, nausea, or stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking nitazoxanide, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a weakened immune system (such as HIV infection).The liquid form of this medication contains sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. For the liquid form of this drug, discard any unused medication after 7 days. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2021. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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