Nitazoxanide (nitazoxanide)
Antiprotozoal Agents Oral Tablet
Last reviewed · Source: First Databank (FDB) drug data
Overview
Nitazoxanide, a synthetic nitrothiazolyl-salicylamide derivative, is an antiprotozoal agent.
Nitazoxanide is a synthetic nitrothiazolyl-salicylamide-derivative antiprotozoal agent. Nitazoxanide is rapidly hydrolyzed in vivo to tizoxanide, an active metabolite. Both nitazoxanide and tizoxanide have antiprotozoal activity against the sporozoites and oocysts of Cryptosporidium parvum and the trophozoites of Giardia intestinalis (also known as G. lamblia or G. duodenalis).
The antiprotozoal activity of nitazoxanide may be related principally to its ability to interfere with the pyruvate:ferredoxin 2-oxidoreductase enzyme-dependent electron transfer reaction essential to anaerobic energy metabolism in susceptible organisms such as C. parvum and Giardia. Nitazoxanide and tizoxanide also are active against some other protozoa, including Entamoeba histolytica, Trichomonas vaginalis, Cyclospora cayetanensis, and Isospora belli (Cystoisospora belli).
Nitazoxanide is active against certain helminths, including some cestodes (tapeworms). Although the clinical importance is unclear, nitazoxanide is active in vitro against some anaerobic and microaerophilic gram-positive and gram-negative bacteria, including Clostridioides difficile (formerly known as Clostridium difficile) and Helicobacter pylori, and also is active against some viruses.
Following oral administration, nitazoxanide is rapidly hydrolyzed to tizoxanide (desacetyl-nitazoxanide) and tizoxanide then undergoes conjugation, primarily by glucuronidation. Peak plasma concentrations of tizoxanide and tizoxanide glucuronide usually are attained within 1-5 and 2-8 hours, respectively; nitazoxanide is undetectable in plasma. When nitazoxanide tablets or oral suspension is administered with food, the areas under the plasma concentration-time curves for tizoxanide and tizoxanide glucuronide are increased.
Nitazoxanide tablets and oral suspension are not bioequivalent; the relative bioavailability of the oral suspension compared to that of the tablet is 70%. Tizoxanide is more than 99% bound to plasma proteins. The plasma half-life of nitazoxanide is reported to be 6 minutes.
The median plasma half-lives of tizoxanide and tizoxanide glucuronide are reported to be 1.2-1.5 and 1.9-2.9 hours, respectively, following a single nitazoxanide dose of 0.5-1 g taken with food and 1.8-6.4 and 3.5-5.6 hours, respectively, following repeated nitazoxanide doses of 0.5-1 g taken with food. Tizoxanide is eliminated in urine, bile, and feces; tizoxanide glucuronide is eliminated in urine and bile. Approximately two-thirds of an oral dose of nitazoxanide is excreted in feces and approximately one-third of the dose is excreted in urine.
USES: This medication is used to treat diarrhea caused by certain parasite infections of the intestines (Cryptosporidium parvum and Giardia lamblia).
Generic name: nitazoxanide
Pronunciation: (NYE-ta-ZOX-a-nide)
Drug class: Antiprotozoal Agents
Therapeutic class: Anti-Infective Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Nitazoxanide
Indications
The following indications are listed for Nitazoxanide:
- Giardiasis
- Infection By Cryptosporidium
Also known as: Cryptosporidiosis, Infection Due To Cryptosporidium Parvum, Lambliasis, Lambliosis.
Dosing
Nitazoxanide tablets and oral suspension are not bioequivalent. Bioavailability of the oral suspension is 70% relative to that of the tablet.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Nitazoxanide 500 Mg Tablet | Maintenance | Take 1 tablet (500 mg) by oral route every 12 hours with food. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Nitazoxanide 500 Mg Tablet | Maintenance | Take 1 tablet (500 mg) by oral route every 12 hours with food. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Nitazoxanide is contraindicated in patients hypersensitive to the drug or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Adverse effects reported in 2% or more of patients receiving nitazoxanide include abdominal pain, headache, chromaturia, and nausea.
There are no severe adverse reactions for this drug.
More Frequent
- Acute abdominal pain
- Headache disorder
- Nausea
- Urine discoloration
Less Frequent
- Diarrhea
Rare or Very Rare
- Dizziness
- Dyspnea
- Gastroesophageal reflux disease
- Skin rash
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of nitazoxanide have not been established in pediatric patients younger than 1 year of age.
Nitazoxanide oral suspension: Safety and efficacy for the treatment of diarrhea caused by C. parvum or G. intestinalis (also known as G. lamblia or G. duodenalis) in pediatric patients 1-11 years of age have been established based on results of 3 randomized, controlled studies. Safety and efficacy of the oral suspension for the treatment of diarrhea caused by C. parvum or G. intestinalis in pediatric patients 12-17 years of age have been established based on results of 2 randomized, controlled studies.
Nitazoxanide tablets: Safety and efficacy for the treatment of diarrhea caused by C. parvum or G. intestinalis have been established in pediatric patients 12-17 years of age based on results of 3 randomized, controlled studies. The commercially available 500-mg tablets of nitazoxanide should not be used in pediatric patients 11 years of age or younger since the tablets contain a greater amount of the drug than is recommended in this age group.
Data are not available on use of nitazoxanide in pregnant women to inform a drug-associated risk.
In animal reproduction studies, there was no evidence of teratogenicity or fetotoxicity in rats or rabbits when nitazoxanide was given during organogenesis at exposures 30 or 2 times, respectively, the human exposure at the recommended human dosage of 500 mg twice daily based on body surface area.
It is not known whether nitazoxanide is distributed into human milk, affects milk production, or affects a breast-fed child.
The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for nitazoxanide and potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Clinical studies of nitazoxanide did not include a sufficient number of individuals 65 years of age and older to determine whether geriatric adults respond differently than younger individuals. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy in this age group should be considered.
ICD codes
| Code | Type | Description |
|---|---|---|
| Giardiasis | ||
| A07.1 | ICD10CM | Giardiasis [lambliasis] |
| Infection by cryptosporidium | ||
| A07.2 | ICD10CM | Cryptosporidiosis |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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