Nitazoxanide (Nizonide) is a broad-spectrum antiparasitic drug that belongs to the class thiazolides used to treat diarrheal diseases.

Nitazoxanide (Nizonide) Uses:

• Infectious Diarrhea:

  • Used for treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia

• Off Label Use of Nitazoxanide in Adults:

  • Clostridioides (formerly Clostridium) difficile infection;
  • Cryptosporidiosis-associated diarrhea in HIV-infected patients

Nitazoxanide (Nizonide) use in COVID-19 infections:

Nitazoxanide has been previously studied in patients with MERS-COV infections that belong to the class of viruses called as Coronaviruses. It is thought to act as antiviral by potentiating and increasing the production of interferon-alpha and interferon-beta in the body. Some authors have suggested its use in combination with azithromycin in patients with COVID-19 infections [Ref]. Studies are also being conducted to evaluate its efficacy in COVID-19 infections in combination with hydroxychloroquine [Ref] and Ivermectin [Ref].

Nitazoxanide (Nizonide) Dose in Adults

Nitazoxanide (Nizonide) Dose in the treatment of Diarrhea, infectious caused by Cryptosporidium parvum or Giardia lamblia:

Oral suspension or tablets:

• 500 mg every 12 hours for 3 days

Nitazoxanide (Nizonide) Dose in the treatment of Clostridioides (formerly Clostridium) difficile infection (off-label):

Oral suspension or tablets:

• 500 mg every 12 hours for 7 to 10 days

Nitazoxanide (Nizonide) Dose in the treatment of Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label):

• Oral: 500 to 1,000 mg twice a day for 14 days (must be used in conjunction with optimized ART, electrolyte replacement, and symptomatic treatment and rehydration).

Nitazoxanide (Nizonide) Dose in Childrens

Note:

• The oral suspension should be used for doses <500 mg.

Nitazoxanide (Nizonide) Dose in the treatment of Cryptosporidiosis (Cryptosporidium parvum):

Note:

• • The typical course of treatment for non-HIV patients is three days (Red Book [AAP 2015]).
  • There aren't many consistently effective therapy choices for patients who are HIV-exposed or positive.
  • In conjunction with optimum combination antiretroviral medication, a treatment period of 3 to 14 days is advised.
• Children 1 to 3 years: Oral:
  • 100 mg every 12 hours
• Children 4 to 11 years: Oral:
  • 200 mg every 12 hours
• Children ≥12 years and Adolescents: Oral:
  • 500 mg every 12 hours

Nitazoxanide (Nizonide) Dose in the treatment of Fasciola hepatica (sheep liver fluke):

Children 1 to 3 years:

• Oral: For seven days, 100 mg every 12 hours.

Children 4 to 11 years:

• Oral: For seven days, 200 mg every 12 hours.

Children ≥12 years and Adolescents:

• Oral: For seven days, 500 mg every 12 hours.

Nitazoxanide (Nizonide) Dose in the treatment of Giardiasis (Giardia intestinalis, Giardia lamblia, and G.duodenalis) regardless of HIV-status:

Children 1 to 3 years:

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• Oral: three days of 100 mg every 12 hours

Children 4 to 11 years:

• Oral: for three days, 200 mg every 12 hours.

Children ≥12 years and Adolescents:

• Oral: 3 days of taking 500 mg every 12 hours

Nitazoxanide (Nizonide) Dose in the treatment of Hymenolepis nana (dwarf tapeworm):

Children 1 to 3 years:

• three days at 100 mg twice every day

Children 4 to 11 years:

• three days at 200 mg twice every day

Children ≥12 years and Adolescents:

• Oral: three days at 500 mg twice every day

Nitazoxanide (Nizonide) Dose in the treatment of acute uncomplicated Influenza:

Children ≥12 years and Adolescents: Oral:

• 600 mg twice a day for 5 days; in a double-blind, placebo-controlled trial of 624 subjects (age range: 12 to 65 years).
• A 5-day course was reported to shorten the duration of symptoms (Haffizulla 2014).

Pregnancy Risk Category: B

• Animal reproduction studies have shown that adverse events are rare.
• The human data are not available. However, women suffering from severe cryptosporidiosis symptoms may be able to use the drug during pregnancy.

Use of nitazoxanide while breastfeeding

• It is unknown if the drug is found in breast milk.
• According to the manufacturer breast-feeding during therapy should be considered in light of the risks to the infant and the benefits to the mother.

Nitazoxanide (Nizonide) Dose in Kidney Disease:

• There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Nitazoxanide (Nizonide) Dose in Liver disease:

• There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Side Effects of Nitazoxanide (Nizonide):

• Central nervous system:

  • Headache

• Gastrointestinal:

  • Abdominal pain
  • Nausea

• Genitourinary:

  • Urine discoloration

Contraindications to Nitazoxanide (Nizonide):

Hypersensitivity to nitazoxanide and any component of the formulation

Warnings and precautions

• HIV infection

  • For the treatment of G.Lamblia-caused diarrhea in HIV-infected patients, Nitazoxanide is not yet studied.
  • It does not outperform a placebo in the treatment of diarrhoea brought on by C. parvum in HIV-positive individuals.

Monitoring parameters:

None mentioned.

How to administer Nitazoxanide (Nizonide)?

• Administer with food.
• Prior to administration shake suspension well

Mechanism of action of Nitazoxanide (Nizonide):

• In-vivo, it is swiftly converted to the active metabolite, tizoxanide.
• Interfering with the pyruvate-ferredoxin oxidoreductase (PFOR) enzyme dependent electron transfer process, which is essential for anaerobic metabolism, could result in activity.
• Both nitazoxanide and tizoxanide limit the growth of Cryptosporidium parvum oocysts and sporozoites in vitro.

Notice:

• Pediatric patients (ages 1-18) have pharmacokinetic properties that are similar to those of adults, provided they are administered in the same dose.

Protein binding:

• Tizoxanide: >99%

Bioavailability:

• Relative bioavailability of suspension compared to tablet: 70%; tablet and suspension are not bioequivalent

Half-life elimination:

• Tizoxanide: 1 to 1.6 hours

Metabolism:

• Hepatic, to an active metabolite, tizoxanide.
• Tizoxanide undergoes conjugation to form tizoxanide glucuronide.
• Nitazoxanide is not detectable in the serum following oral administration.

Time to peak, plasma:

• Tizoxanide and tizoxanide glucuronide: 1 to 4 hours

Excretion:

• Urine (~33%)
• feces (~67%)

International Brands of Nitazoxanide (Nizonide):

• Alinia
• Adnix
• Anelmin
• Annita
• Celectan
• Colufase
• Coluquim
• Daxon
• Dexidex
• Diar
• Diasis
• Givotan
• Heliton
• Kidonax
• Nidozox
• Nitalet
• Nitarid
• Noxom
• Pacovanton
• Paramix

Nitazoxanide Brand Names in Pakistan: