Nitazoxanide

Nitazoxanide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• There is limited information regarding FDA-LABELED Guideline-Supported Use of Nitazoxanide in adult patients.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Nitazoxanide in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitazoxanide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum:

• Alinia for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

• Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients

Dosage

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Nitazoxanide in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Nitazoxanide in pediatric patients.

Contraindications

• Alinia Tablets and Alinia for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

Warnings

There is limited information regarding Nitazoxanide Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

• Alinia Tablets: In controlled and uncontrolled clinical studies of 1,657 HIV-uninfected patients age 12 years and older who received various dosage regimens of Alinia Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Alinia Tablets for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum, less than 1% of patients discontinued therapy because of an adverse event.

• Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia Tablets are listed below:

• Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic pain, back pain, chills, chills and fever, flu syndrome.

• Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia.

• Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst.

• Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia.

• Metabolic & Nutrition: increased SGPT.

• Hemic & Lymphatic Systems: anemia, leukocytosis.

• Skin: rash, pruritus.

• Special Senses: eye discoloration, ear ache.

• Respiratory System: epistaxis, lung disease, pharyngitis.

• Cardiovascular System: tachycardia, syncope, hypertension.

• Muscular System: myalgia, leg cramps, spontaneous bone fracture.

Alinia for Oral Suspension:

• In controlled and uncontrolled clinical studies of 613 HIV-uninfected pediatric patients who received Alinia for Oral Suspension, the most frequent adverse events reported regardless of causality assessment were: abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials, the rates of occurrence of these events did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of adverse events.

• Adverse events occurring in less than 1% of the pediatric patients participating in clinical trials of Alinia for Oral Suspension are listed below:

• Digestive System: nausea, anorexia, flatulence, appetite increase, enlarged salivary glands.

• Body as a Whole: fever, infection, malaise.

• Metabolic & Nutrition: increased creatinine, increased SGPT.

• Skin: pruritus, sweat.

• Special Senses: eye discoloration (pale yellow).

• Respiratory System: rhinitis.

• Nervous System: dizziness.

• Urogenital System: discolored urine.

• The adverse events seen in adult patients treated with Alinia for Oral Suspension were similar to those observed in adult patients treated with Alinia Tablets.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Nitazoxanide in the drug label.

Drug Interactions

• Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin). In vitro metabolism studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes. Although no drug-drug interaction studies have been conducted in vivo, it is expected that no significant interaction would occur when nitazoxanide is co-administered with drugs that either are metabolized by or inhibit cytochrome P450 enzymes.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category B: Reproduction studies have been performed at doses up to 3,200 mg/kg/day in rats (approximately 26 times the clinical adult dose adjusted for body surface area) and 100 mg/kg/day in rabbits (approximately 2 times the clinical adult dose adjusted for surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to nitazoxanide. There are, however, no adequate and well-controlled studies in pregnant women.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nitazoxanide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nitazoxanide during labor and delivery.

Nursing Mothers

• It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.

Pediatric Use

• A single Alinia Tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger. Alinia for Oral Suspension should be used for dosing nitazoxanide in pediatric patients.

• Safety and effectiveness of Alinia for Oral Suspension in pediatric patients less than 1 year of age have not been studied.

Geriatic Use

• Clinical studies of Alinia Tablets and Alinia for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Alinia Tablets and Alinia for Oral Suspension. As stated in the precautions section, this therapy must be administered with caution to patients with renal and or hepatic impairment.

Gender

• There is no FDA guidance on the use of Nitazoxanide with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Nitazoxanide with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Nitazoxanide in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Nitazoxanide in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Nitazoxanide in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Nitazoxanide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Nitazoxanide in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Nitazoxanide in the drug label.

Overdosage

• Information on nitazoxanide overdosage is not available. In acute studies in rodents and dogs, the oral LD50 was higher than 10,000 mg/kg. Single oral doses of up to 4,000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be carefully observed and given symptomatic and supportive treatment.

Pharmacology

There is limited information regarding Nitazoxanide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Nitazoxanide Mechanism of Action in the drug label.

Structure

There is limited information regarding Nitazoxanide Structure in the drug label.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Nitazoxanide in the drug label.

Pharmacokinetics

• There is limited information regarding Pharmacokinetics of Nitazoxanide in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Long-term carcinogenicity studies have not been conducted.

• Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. Nitazoxanide was genotoxic in 1 tester strain (TA 100) in the Ames bacterial mutation assay.

• Nitazoxanide did not adversely affect male or female fertility in the rat at 2,400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area).

Clinical Studies

There is limited information regarding Clinical Studies of Nitazoxanide in the drug label.

How Supplied

• Alinia Tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 30 tablets.

Bottles of 30 NDC 67546-111-12

• Alinia for Oral Suspension is a pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor. Alinia for Oral Suspension is available as:

Bottles of 60 mL NDC 67546-212-21

Storage

• Storage and Stability: Store the tablets, unsuspended powder, and the reconstituted oral suspension at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nitazoxanide in the drug label.

Precautions with Alcohol

• Alcohol-Nitazoxanide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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