tinidazole (Rx)

Brand and Other Names:Tindamax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 250mg
  • 500mg

Amebiasis, Intestinal

2 g/day PO for 3 days

Amebic Liver Abscess

2 g/day PO for 3-5 days

Giardiasis or Trichomoniasis

2 g PO once

Bacterial Vaginosis (Nonpregnant)

2 g PO qDay for 2 days OR 1 g PO qDay for 5 days

Administration

Take with food

For trichomoniasis, treat sexual partners concurrently with same dose

Dosage Forms & Strengths

tablet

  • 250mg
  • 500mg

Amebiasis, Intestinal

< 3 years

  • Safety and efficacy not established

>3 Years

  • 50 mg/kg/day PO for 3 days; 2 g maximum  

Amebic Liver Abscess

< 3 years

  • Safety and efficacy not established

>3 Years

  • 50 mg/kg/day PO for 5 days; 2 g maximum  

Giardiasis

< 3 years

  • Safety and efficacy not established

>3 Years

  • 50 mg/kg PO once; 2 g maximum  

Administration

Take with food

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Interactions

Interaction Checker

and tinidazole

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%

            Anorexia (2-3%)

            Constipation (<1%)

            Dizziness (<1%)

            Dysgeusia (4-6%)

            Dyspepsia (1-2%)

            Headache (<1%)

            Nausea (3-5%)

            Vomiting (1-2%)

            Weakness/fatigue/malaise (1-2%)

            Frequency Not Defined

            Ataxia

            Candida overgrowth

            Convulsions & transient peripheral neuropathy

            Numbness & paresthesia

            Diarrhea

            Darkened urine

            Tongue discoloration

            Transient leukopenia/neutropenia

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            Warnings

            Black Box Warnings

            Carcinogenicity has been seen in mice and rats chronically treated with metronidazole, another agent in the nitroimidazole class. Although such data have not been reported with tinidazole, the 2 drugs are structurally related and have similar biological effects

            Limit use to approved indications only; avoid chronic use

            Contraindications

            Hypersensitivity

            1st trimester of pregnancy

            Concurrent lactation (interrupt for 3 days)

            Cautions

            Caution in patients with history of blood dyscrasias or history of hepatic impairment

            Risk of convulsive seizures & peripheral neuropathy - caution in neurologically compromised patients

            Risk of bacterial overgrowth with prolonged treatment

            No safety & efficacy data on pediatric patients <3 years of age

            Not studied for bacterial vaginosis in pregnant women

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            Pregnancy & Lactation

            Pregnancy

            Available published data from a case-control study and case report with use in pregnant women are insufficient to identify risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks associated with untreated lower genital tract infections during pregnancy

            Infertility

            • Based on findings in rodents, therapy may impair fertility in males of reproductive potential; not known whether effects on fertility are reversible

            Animal data

            • In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at highest dose, with no other adverse fetal effects noted in either species

            Lactation

            Limited published literature, based on breast milk sampling, reports that drug is present in human milk; there are no reports of adverse effects on breastfed infant and no information on effects on milk production

            Because of potential for serious adverse reactions, including tumorigenicity, breastfeeding is not recommended during treatment and for 72 hours (based on half-life) after last dose

            A nursing mother may choose to pump and discard her milk during treatment and for 72 hours after last dose to minimize exposure to breastfeeding infant

            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

            Antiprotozoal; may cause cytotoxicity by damaging DNA and preventing further DNA synthesis

            Pharmacokinetics

            Half-life: 12-14 hr

            Metabolism: Mainly by CYP3A4

            Vd: 50L

            Protein binding: 12%

            Peak plasma time: 1.6 hr

            Metabolites: Undergoes oxidation, hydroxylation & conjugation

            Excretion: Mainly in urine (20-25% as unchanged drug); feces: 12%

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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.