nitazoxanide (Rx)

Brand and Other Names:Alinia
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and nitazoxanide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (4)

              • 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.

              • phenytoin

                nitazoxanide, phenytoin. Either increases levels of the other by Mechanism: plasma protein binding competition. 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.

              • warfarin

                nitazoxanide, warfarin. Either increases levels of the other by plasma protein binding competition. Avoid or Use Alternate Drug. the active metabolite of nitazoxanide is highly protein bound; avoid use of warfarin with nitazoxanide.

              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.

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              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

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              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
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              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.

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              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

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              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

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Alinia oral
              -
              100 mg/5 mL suspension
              Alinia oral
              -
              500 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              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: This drug usually has no side effects. If you have any unusual effects, contact 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: liver disease, kidney disease, 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 August 2021. Copyright(c) 2021 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.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.