nitazoxanide (Rx)

Brand and Other Names:Alinia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 500mg

oral suspension

  • 100mg/5mL
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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
more...

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

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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

            Oral Administration

            Take with food

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            Images

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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.