TINDAMAX SUMMARY
Tindamax® (tinidazole) oral tablets
Tinidazole is a synthetic antiprotozoal agent.
Tinidazole is indicated for the following:
Trichomoniasis:
Tindamax oral tablets are indicated for the treatment of trichomoniasis caused by T. vaginalis in both female and male patients. 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.
Giardiasis:
Tindamax oral tablets are indicated for the treatment of giardiasis caused by
G. duodenalis
(also termed
G. lamblia) in both adults and pediatric patients older than three years of age.
Amebiasis:
Tindamax oral tablets are indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by
E. histolytica
in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.
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NEWS HIGHLIGHTS
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)
A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis [Terminated]
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.
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) [Recruiting]
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 for Recurrent Bacterial Vaginosis: A Pilot Study [Recruiting]
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.
Treatment of BV With Tinidazole [Recruiting]
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better
than treatment with metronidazole
Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax [Recruiting]
Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine
to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to
justify an IND and formal phase II evaluation.
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