Home » Drug Information » FDA Approved Drugs » 2004
Medical Areas: Immunology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Presutti Laboratories
Approval Status: Approved May, 2004
Treatment Area: Protozoal infections
Tindamax tablets contain the antimicrobial agent tinidazole, a
second generation synthetic nitroimidazole. The drug has activity
against many species of infectious protozoals, including those
which sexually transmitted and water borne. It was designed to be
effective in the short term, with treatment usually ranging from
just a single dose to as long as 3 days.
Tinidazole tablets are indicated for the treatment of the
following protozoal infections
- Trichomoniasis caused by T. vaginalis in both male and
- Giardiasis caused by G. duodenalis\G. lamblia)
- Amebiasis and amebic liver abscess caused by E.
Tindamax is supplied as an oral tablet at one of two dosing
stregths (250 and 500 mg), and is designed to be taken with food.
For trichomoniasis and giardiasis, recommended dosage is a single
dose of 2 g. For amebiasis/amebic abscess, recommended dosage is 2
g once daily for three days. Pediatric doses should be adjusted by
patient weight at 50 mg/kg, up to 2 g total dose.
Approval of Tindamax for trichomoniasis was based on the
combined results of 34 studies involving over 2,800 subjects. 4
blinded, randomized, comparative studies in which the 2 g single
oral dose was used assessed efficacy by culture at time points
post-treatment ranging from one week to one month. Reported cure
rates ranged from 92% (37/40) to 100% (65/65) (n=172 total
subjects). 4 blinded, randomized, comparative studies assessed
efficacy by wet mount between 7-14 days post-treatment. Reported
cure rates ranged from 80% (8/10) to 100% (16/16) (n=116 total
subjects). In these studies, tinidazole was superior to placebo and
comparable to other anti-trichomonal drugs. The single oral 2 g
tinidazole dose was also assessed in 4 open label trials in men
(one comparative to metronidazole and 3 single arm studies).
Parasitological evaluation of the urine was performed both pre- and
post-treatment, and reported cure rates ranged from 83% (25/30) to
100% (80/80) (n=142 total subjects).
Approval for giardias was based on 19 studies involving 1,600
adult and pediatric subjects. In eight controlled studies involving
a total of 619 subjects, of whom 299 were given the 2 g (50 mg/kg
in pediatric patients) single oral dose of tinidazole, reported
cure rates ranged from 80% (40/50) to 100% (15/15). In three of
these trials where the comparator was 2 to 3 days of various doses
of metronidazole, reported cure rates for metronidazole were 76%
(19/25) to 93% (14/15). Data comparing a single 2 g dose of
tinidazole to the recommended 5-7 days of metronidazole are
Approval for amebiasis was based on 26 reported studies
involving over 1,400 subjects. The majority of studies investigated
the 2 g daily oral dose for 3 days. In four randomized, controlled
studies (1 investigator single-blind, 3 open-label)using this dose,
reported cure rates after three days among 220 subjects ranged from
86% (25/29) to 93% (25/27). Approval for amebic liver abscess was
based on 18 reported studies treating a total of 470 subjects.
Subjects in these studies received the 2 g oral dose for 2-5 days.
In 7 randomized, controlled studies (1 double-blind, 1
single-blind, 5 open-label) at that dose, (with additional
aspiration of the liver abscess when clinically necessary),
reported cure rates among 133 subjects ranged from 81% (17/21) to
100% (16/16); 4 of these studies utilized at least 3 days of
Adverse events associated with the use of Tindamax may include
(but are not limited to) the following:
- Metalic Taste
Mechanism of Action
Tindamax is a second generation small-molecule antiprotozoal
agent. While the precise mechanism of action is unknown, cell
extracts from Trichomonas have been shown to reduce the
molecule's nitro group, producing cytotoxic free radicals. The
mechanism of action against Giardia and Entamoeba
species is unknown, but activity has been confirmed both in
vitro and in vivo.
Manes G, Balzano A. Tinidazole: from protozoa
to Helicobacter pylori--the past, present and future of a
nitroimidazole with peculiarities. Expert Review of
Anti-infective Therapy. 2004 Oct;2(5):695-705
Hager WD. Treatment of metronidazole-resistant
Trichomonas vaginalis with tinidazole: case reports of three
patients. Sexually Transmitted Diseases. 2004
Wright JM, Dunn LA, Upcroft P, Upcroft JA.
Efficacy of antigiardial drugs. Expert Opinions on Drug
Safety. 2003 Nov;2(6):529-41
For additional information regarding Tindamax or protozoal
infections, please visit the Tindamax web page.