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Tindazole (Tinidazole) - Summary



Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitromidazole agent (13.1). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE (1).



Tinidazole is a synthetic antiprotozoal and antibacterial agent.


Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies ].


Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age [see Clinical Studies].


Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage [see Clinical Studies (14.3, 14.4)].

Bacterial Vaginosis

Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women [see Use in Specific Populations and Clinical Studies].

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Published Studies Related to Tindazole (Tinidazole)

Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. [2007]
cure... CONCLUSION: Both tinidazole regimens studied provided effective treatment for

One-week therapy for Helicobacter pylori eradication: ranitidine bismuth citrate plus medium-dose clarithromycin and either tinidazole or amoxycillin. [1998]
medium-dose clarithromycin and either tinidazole or amoxycillin... CONCLUSIONS: One-week regimens consisting of RBC plus clarithromycin and either

One week treatment with omeprazole, clarithromycin and tinidazole or lansoprazole, amoxicillin and metronidazole for cure of Helicobacter pylori infection in duodenal ulcer patients. [1996]
We defined optimal Helicobacter pylori (Hp) treatment as Hp eradication rate about 90%, well-tolerated with few side-effects. Two centers carried out randomized trials including 90 patients (74% men, 26% women, ages ranging from 18 to 65, mean age 42 +/- 8) with active duodenal ulcers (DU)... We conclude that one week treatment using O + C + T or L + A + M are highly and equally effective in the healing of DU and in the eradication of Hp.

A randomized double-blind trial of tinidazole treatment of the sexual partners of females with bacterial vaginosis. [1993]
cure rates as compared with the same treatment for the female patients alone... CONCLUSION: Routine treatment is not recommended for male partners of women with

Tinidazole prophylaxis in elective abdominal hysterectomy. [1993]
CONCLUSION: Tinidazole prophylaxis (2 g oral dose) is considered to be a simple,

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Clinical Trials Related to Tindazole (Tinidazole)

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) [Completed]
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.

Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy [Active, not recruiting]
Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Treatment of Bacterial Vaginosis (BV) With Tinidazole [Completed]
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis [Withdrawn]
This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks.

Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions [Completed]
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

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Page last updated: 2015-08-10

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