WARNING: POTENTIAL RISK FOR CARCINOGENICITY
Carcinogenicity has been seen in mice and rats treated
chronically with metronidazole, another nitroimidazole 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.
Enter section text here
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
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 Tindamax and other antibacterial drugs, Tindamax 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.
Published Studies Related to Tindamax (Tinidazole)
Tinidazole vs metronidazole for the treatment of bacterial vaginosis. [2011.03]
OBJECTIVE: The purpose of this study was to compare the efficacy of 2 different doses of tinidazole with metronidazole for the treatment of bacterial vaginosis and to compare the side effects of the drugs... CONCLUSION: There were no differences in cure rates between metronidazole and either of the tinidazole dosing regimens that were studied. In addition, there were no important differences in the side-effect profiles of metronidazole and tinidazole. Copyright (c) 2011 Mosby, Inc. All rights reserved.
Improved cure of bacterial vaginosis with single dose of tinidazole (2 g), Lactobacillus rhamnosus GR-1, and Lactobacillus reuteri RC-14: a randomized, double-blind, placebo-controlled trial. [2009.02]
Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli... This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition.
Effectiveness of Two Tinidazole Regimens in Treatment of Bacterial Vaginosis: A Randomized Controlled Trial. [2007.08]
OBJECTIVE: To assess the effectiveness at 21-30 days after treatment of tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days, compared with placebo, in the treatment of bacterial vaginosis, using rigorous U.S. Food and Drug Administration (FDA)-recommended criteria to define cure... CONCLUSION: Both tinidazole regimens studied provided effective treatment for bacterial vaginosis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00229216 LEVEL OF EVIDENCE: I.
A randomized, controlled, open-label trial of a single day of mebendazole versus a single dose of tinidazole in the treatment of giardiasis in children. [2006.11]
CONCLUSIONS: Three doses of mebendazole, in a single day, are inferior to a single dose tinidazole in the treatment of giardiasis.
One-week versus two-week H2-receptor antagonist in combination with amoxicillin and tinidazole for eradication of Helicobacter pylori infection. [2005.09]
CONCLUSIONS: A 2-week course of high-dose H2-RA-based triple therapy is well tolerated and sufficiently effective in eradicating H. pylori infection. Presence of metronidazole resistance has a negative impact on the treatment efficacy.
Clinical Trials Related to Tindamax (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.
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
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.
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.
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study [Completed]
This research study is being done to evaluate the use of an oral (by mouth) medication
called tinidazole to initially treat BV and then to see if additional treatment with
tinidazole keeps women from getting this infection back within 3 months. Tinidazole is
currently approved by the United States Food and Drug Administration (FDA) to treat
bacterial vaginosis (BV).
This study will evaluate the use of tinidazole to treat a woman's current BV infection and
then will look at using tinidazole as a suppressive treatment (taking medication regularly
to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment
phase will include using tinidazole twice a week compared to using placebo twice a week and
then following women for recurrence of BV. The purpose of this study is to determine if
tinidazole suppression will prevent BV from coming back within 3 months of treatment.
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who
are randomized to a suppressive regimen (a dose of medication given on a regular basis to
attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have
lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared
to those women randomized to placebo.
Page last updated: 2011-12-09