Tinidazole

Pronunciation

Class: Antiprotozoals, Miscellaneous
VA Class: AP109
Chemical Name: 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazole
Molecular Formula: C8H13N3O4S
CAS Number: 19387-91-8
Brands: Tindamax

Warning(s)

  • Metronidazole (a nitroimidazole anti-infective chemically similar to tinidazole) is carcinogenic in mice and rats.1 31

  • Carcinogenic potential of tinidazole not evaluated in animal studies to date.1

  • Avoid unnecessary use; reserve for use in approved indications.1 (See Uses.)

Introduction

Antiprotozoal and antibacterial; 1 58 59 63 64 65 68 nitroimidazole derivative.1 58 59 63 64 65 68

Uses for Tinidazole

Amebiasis

Treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and children >3 years of age.1 18 25 26 27 28 29 30 34 43 47 48 49 50 51 52 53 54 69 Designated an orphan drug by FDA for treatment of amebiasis.2

Oral tinidazole or oral metronidazole followed by a luminal amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.18 24 25 26 27 34 47

Not recommended for treatment of asymptomatic cyst passers;1 18 47 these patients should be treated with a luminal amebicide such as iodoquinol, paromomycin, or diloxanide furoate (not commercially available in the US).18 25 26 27

Giardiasis

Treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis) in adults and children >3 years of age.1 18 20 21 22 23 24 34 40 41 43 44 45 46 56 57 Designated an orphan drug by FDA for use in this condition.2

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Drugs of choice are metronidazole,17 18 20 tinidazole,17 18 20 or nitazoxanide;17 18 alternatives are paromomycin (especially in pregnant women),17 18 20 furazolidone (not commercially available in the US),17 18 20 or quinacrine (not commercially available in the US).17 18

Treatment of asymptomatic carriers of giardiasis not recommended, except possibly to prevent transmission from carriers in households of patients with hypogammaglobulinemia or cystic fibrosis or pregnant women with toddlers.18

Trichomoniasis

Treatment of symptomatic and asymptomatic trichomoniasis in men and women in whom Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).1 3 4 5 9 11 13 14 15 16 18 35 36 38 39 67 68

Drug of choice is metronidazole or tinidazole.9 17 18 Tinidazole may be effective in some patients who do not respond to metronidazole,3 62 but some T. vaginalis isolates with reduced susceptibility to metronidazole may also have reduced susceptibility to tinidazole.1 61 62

Goal of treatment is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission.1 7 8 9 15 To achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated simultaneously;1 7 8 9 15 treat sexual contacts presumptively even if they are asymptomatic and/or T. vaginalis has not been demonstrated.67

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in nonpregnant women.1 72 73 Rule out other pathogens commonly associated with vulvovaginitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses).1

CDC recommends treatment of bacterial vaginosis in all symptomatic nonpregnant women.9 Routine treatment of sex partners not recommended.9

Nongonococcal Urethritis

Treatment of recurrent and persistent urethritis in patients with nongonococcal urethritis who have already been treated with a recommended regimen.9

For treatment of nongonococcal urethritis in adults, CDC recommends a single oral dose of azithromycin or a 7-day regimen of doxycycline; alternative regimens are a 7-day regimen of oral erythromycin base or ethylsuccinate or a 7-day regimen of oral ofloxacin or oral levofloxacin.9 Patients are instructed to abstain from sexual intercourse until 7 days after initiation of treatment and to return for evaluation if symptoms persist or recur after completion of therapy; symptoms alone (without documentation of signs or laboratory evidence of urethral inflammation) are not sufficient basis for retreatment.9

Patients with persistent or recurrent urethritis who were not compliant with the treatment regimen or were reexposed to untreated sexual partner(s) should be retreated with the initial regimen.9 If patient with recurrent and persistent urethritis was compliant with the regimen and reexposure can be excluded, CDC recommends a single oral dose of metronidazole or tinidazole given in conjunction with a single oral dose of azithromycin (if azithromycin was not used in the initial regimen).9

Tinidazole Dosage and Administration

Administration

Oral Administration

Administer orally once daily with food.1

Administration with meals may reduce incidence of adverse GI effects.1

Do not consume alcohol during or for 3 days after completion of tinidazole therapy.1

For children and other patients unable to swallow tablets, an oral suspension may be prepared extemporaneously using the tablets.1

Extemporaneous Oral Suspension

To prepare an oral suspension containing 66.7 mg/mL, grind 2 g (four 500-mg tablets) to a fine powder with a mortar and pestle.1 Add approximately 10 mL of cherry syrup to the powder and mix until smooth.1 Transfer suspension to a graduated amber container;1 use several small rinses of the cherry syrup to transfer any remaining drug in the mortar to provide a suspension with a final volume of 30 mL.1

Shake suspension well prior to administration of each dose.1

Dosage

Pediatric Patients

Amebiasis
Entamoeba histolytica Infections
Oral

Children >3 years of age (intestinal amebiasis): 50 mg/kg (up to 2 g) once daily given for 3 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47

Children >3 years of age (amebic liver abscess): 50 mg/kg (up to 2 g) once daily given for 3–5 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47

Giardiasis
Oral

Children >3 years of age: 50 mg/kg (up to 2 g) given as a single dose.1 17

Trichomoniasis
Oral

Children >3 years of age: 50 mg/kg (up to 2 g) given as a single dose.17

Adults

Amebiasis
Entamoeba histolytic Infections
Oral

Intestinal amebiasis: 2 g once daily given for 3 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47

Amebic liver abscess: 2 g once daily for 3–5 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47

Giardiasis
Oral

2 g given as a single dose.1 17

Trichomoniasis
Oral

2 g given as a single dose.1 9 17

Treat sexual partners of the patient simultaneously using the same dosage.1 9 67

For treatment failure following a metronidazole regimen (e.g., single 2-g dose of metronidazole), CDC recommends retreatment with a single 2-g dose of tinidazole; if retreatment fails, CDC recommends tinidazole 2 g once daily for 5 days.9 If multiple-dose regimen fails, consult a specialist.9

Bacterial Vaginosis
Nonpregnant Women
Oral

2 g once daily for 2 days or 1 g once daily for 5 days.1

Nongonococcal Urethritis
Oral

CDC recommends a single 2-g dose of tinidazole in conjunction with a single1-g dose of oral azithromycin (if azithromycin not used in the initial regimen) for treatment of recurrent and persistent urethritis in patients who previously received a recommended regimen. (See Nongonococcal Urethritis under Uses.)9

Prescribing Limits

Pediatric Patients

Oral

Children >3 years of age: Maximum 50 mg/kg (up to 2 g) daily or as a single dose.1 17

Special Populations

Hepatic Impairment

Data insufficient to make specific dosage recommendations.1 Use usual dosage with caution.1 (See Hepatic Impairment under Cautions.)

Renal Impairment

Dosage adjustments not needed, unless patient is undergoing hemodialysis.1 60

If given on a day that hemodialysis is performed, administer an additional dose (equivalent to 50% of the recommended dose) after the dialysis session.1 60

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Cautions for Tinidazole

Contraindications

  • History of hypersensitivity reaction to tinidazole or other nitroimidazole derivatives.1

  • First trimester of pregnancy.1

  • Breast-feeding.1 (See Lactation under Cautions.)

Warnings/Precautions

Warnings

Carcinogenicity

Carcinogenic effects reported in mice and rats following chronic oral administration of metronidazole (a chemically related nitroimidazole anti-infective).1 31 (See Boxed Warning). Similar animal studies using tinidazole have not been reported to date.1

Because of potential risks, tinidazole should be reserved for approved indications only and unnecessary use avoided.1

Nervous System Effects

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with tinidazole and other nitroimidazoles (e.g., metronidazole).1 31

If abnormal neurologic signs develop, promptly discontinue drug.1

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria, pruritus, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema, bronchospasm, dyspnea, Stevens-Johnson syndrome, erythema multiforme) reported.1 55

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of tinidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasia.1 58

As with other nitroimidazoles (e.g., metronidazole), transient leukopenia and neutropenia may occur; persistent hematologic abnormalities not reported to date.1 31 58

If retreatment is necessary, perform total and differential leukocyte counts.1

Candidiasis

Vaginal candidiasis reported; treat with an appropriate antifungal.1

Specific Populations

Pregnancy

Category C (second and third trimesters).1

Contraindicated during first trimester.1

Not evaluated for treatment of bacterial vaginosis in pregnant women.1

Lactation

Distributed into milk in concentrations similar to serum concentrations.1 66 Interrupt breast-feeding during therapy and for 72 hours following the last dose.1 66

Pediatric Use

Safety and efficacy not established in pediatric patients ≤3 years of age.1 Some data available regarding safety and efficacy for treatment of giardiasis in pediatric patients <3 years of age.18 23 32 42 43 44 57

Safety and efficacy in pediatric patients >3 years of age established only for treatment of amebiasis or giardiasis.1 18

Monitor pediatric patients closely if duration of therapy is >3 days (e.g., for treatment of amebic liver abscess)1 since only limited data available.1 32 69

Adverse effects reported in pediatric patients generally similar in nature and frequency to those reported in adults.1

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.1

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Hepatic Impairment

Use with caution;1 pharmacokinetics not evaluated.1

Studies using metronidazole (a chemically similar nitroimidazole) indicate reduced elimination and increased plasma concentrations in severe hepatic dysfunction.1 31

Renal Impairment

Dosage adjustment may be needed in patients undergoing hemodialysis.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (metallic/bitter taste, nausea, anorexia, dyspepsia/cramps/epigastric discomfort, vomiting, constipation), nervous system effects (weakness/fatigue/malaise, dizziness, headache).1

Interactions for Tinidazole

Metabolized principally by CYP3A4.1

Does not inhibit CYP1A2, 2B6, 2C9, 2D6, 2E1, or 3A4 in vitro.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma tinidazole concentrations).1

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma tinidazole concentrations).1

Specific Drugs and Laboratory Tests

No formal drug interaction studies performed with tinidazole to date; interactions reported with metronidazole (a chemically similar nitroimidazole) may occur with tinidazole.1

Drug or Test

Interaction

Comments

Alcohol

Alcoholic beverages or preparations containing alcohol or propylene glycol may cause abdominal cramps, nausea, vomiting, headaches, and flushing 1

Avoid alcoholic beverages and preparations containing alcohol or propylene glycol during or for 3 days following completion of tinidazole therapy1

Anticoagulants, oral (warfarin)

Possible increased PT and enhanced anticoagulant effects1

Monitor PT and warfarin dosage carefully during concomitant use and for up to 8 days after the last tinidazole dose1 32

Antifungal agents (ketoconazole)

Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1

Cholestyramine

Studies using metronidazole indicate cholestyramine decreases oral bioavailability of the nitroimidazole by 21%1

Give tinidazole and cholestyramine doses at separate times1

Cimetidine

Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1

Disulfiram

Experience with metronidazole and disulfiram indicates psychotic reactions can occur; such reactions not reported to date with tinidazole 1 31

Do not use concomitantly; do not initiate tinidazole until 2 weeks after disulfiram is discontinued1

Fluorouracil

Experience with metronidazole and fluorouracil indicates decreased fluorouracil clearance, increased fluorouracil-associated adverse effects, no increased therapeutic benefit1

If concomitant use of tinidazole and fluorouracil is unavoidable, monitor for fluorouracil toxicity1

Immunosuppressive agents (cyclosporine, tacrolimus)

Experience with metronidazole indicates increased plasma concentrations of cyclosporine or tacrolimus1

Monitor for cyclosporine or tacrolimus toxicity if tinidazole used concomitantly with one of these drugs1

Lithium

Experience with metronidazole and lithium indicates increased lithium concentrations;1 not reported to date with tinidazole1

Measure serum lithium and creatinine concentrations after several days of concomitant lithium and tinidazole therapy to detect potential lithium intoxication1

Phenobarbital

Possible increased elimination and decreased plasma concentrations of tinidazole1

Phenytoin or fosphenytoin

Experience with oral metronidazole and IV phenytoin indicates prolonged phenytoin half-life and reduced phenytoin clearance;1 not reported with oral phenytoin and oral metronidazole1

Possible increased elimination and decreased plasma concentrations of tinidazole1

Rifampin

Possible increased elimination and decreased plasma concentrations of tinidazole1

Tests based on ultraviolet (UV) absorbance

Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during tinidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD1

UV absorbance peaks of NADH and tinidazole are similar1

Use caution when interpreting test results based on UV absorbance during tinidazole therapy1

Tetracyclines

Experience with metronidazole indicates oxytetracycline (no longer commercially available in the US) may inhibit therapeutic effects of the nitroimidazole1

Tinidazole Pharmacokinetics

Absorption

Bioavailability

Estimated oral bioavailability >90%.63

Rapidly absorbed following oral administration; peak plasma concentrations usually attained within about 2 hours.1 32 63 68

Pharmacokinetic parameters reported with extemporaneous oral suspension containing 66.7 mg/mL (prepared using crushed 500-mg tablets and cherry syrup) in healthy individuals after an overnight fast similar to those reported with tablets swallowed whole under fasted conditions.1 32

Food

Administration with food delays time to peak plasma concentrations by approximately 2 hours and decreases peak plasma concentrations by 10%,1 32 but does not affect AUC or elimination half-life.1 32

Distribution

Extent

Distributed into virtually all body tissues and body fluids.1 32 63

Crosses blood-brain barrier.1 32 63

Crosses placenta and is distributed into breast milk.1

Plasma Protein Binding

12%.1 32 63

Elimination

Metabolism

Extensively metabolized prior to elimination.1 63 1

Partially metabolized via oxidation, hydroxylation, and conjugation.1 63 Metabolized principally by CYP3A4.1

Present in plasma principally as unchanged drug with small amounts of the 2-hydroxymethyl metabolite.1 32 63

Elimination Route

Eliminated by the liver and kidneys.1

Excreted in urine as unchanged drug (20–25%) and in feces (12%).1 32 63 68

Removed by hemodialysis.1 60

Not known whether removed by CAPD.1

Half-life

Approximately 12–14 hours.1 32 58 63 68

Special Populations

Hepatic impairment: Pharmacokinetics not evaluated.1 Studies using metronidazole (a chemically similar nitroimidazole) indicate reduced elimination and increased plasma concentrations in severe hepatic impairment.1 31

Severe renal impairment: Pharmacokinetics not affected by severe impairment (Clcr <22 mL/min).1

Hemodialysis patients: Clearance increased and elimination half-life decreased (from 12 hours to 4.9 hours).1 60 (See Renal Impairment under Dosage and Administration.)

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C);1 protect from light.1

Extemporaneous Oral Suspension

Suspension containing 66.7 mg/mL: Stable for 7 days at room temperature.1 (See Extemporaneous Oral Suspension under Dosage and Administration.)

Actions and Spectrum

  • Amebicidal, trichomonacidal, and bactericidal.1 32 58 59 63 64 65 68

  • Cell extracts of Trichomonas appear to reduce the nitroimidazole group of tinidazole and generate the free nitro radical, which may be responsible for the drug’s anti-infective activity.1 32 59 65 Mechanism of activity against Giardia and Entamoeba histolytica not known.1

  • Protozoa: Active in vitro and in clinical infections against Trichomonas vaginalis, G. duodenalis (also known as G. lamblia or G. intestinalis), and E. histolytica.1 58 59 65

  • Anaerobes: Active in vitro against many anaerobic bacteria including some Bacteroides58 64 (e.g., B. fragilis,32 59 63 64 65 68 B. melaninogenicus63 ), some Clostridium32 59 63 (e.g., C. difficile,32 C. perfringens63 64 ), Prevotella,32 Fusobacterium,63 64 68 Peptococcus,32 58 59 63 and Peptostreptococcus.32 58 59 63

  • Other organisms: Active against Helicobacter pylori 32 and Gardnerella vaginalis.32 59 65 Inactive against most Lactobacillus normally resident in vagina.1 32

  • Potential for development of resistance in Giardia, E. histolytica, or bacteria associated with bacterial vaginosis not evaluated.1

  • Although clinical importance unclear,61 some T. vaginalis with reduced susceptibility to metronidazole also have reduced susceptibility to tinidazole in vitro.1 61 62 61

Advice to Patients

  • Importance of taking with food to reduce the incidence of adverse GI effects (e.g., epigastric discomfort).1

  • Advise patients to avoid alcoholic beverages and preparations containing alcohol or propylene glycol during and for at least 3 days after receiving tinidazole.1

  • Advise patients to promptly discontinue tinidazole and contact clinician if abnormal neurologic signs occur.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tinidazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

250 mg

Tindamax (scored)

Mission

500 mg

Tindamax (scored)

Mission

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Tindamax 500MG Tablets (MISSION): 20/$223.29 or 60/$634.22

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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