• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Tindamax, tinidazole

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Tindamax, tinidazole

  • Profile

Profile

Contact Information

Contact: Mission Pharmacal
Website: https://missionpharmacal.com/

Currently Enrolling Trials

    Show More

    General Information

    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 are 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 three days.

    Tinidazole tablets are indicated for the treatment of the following protozoal infections

    • Trichomoniasis caused by T. vaginalis in both male and female patients
    • Giardiasis caused by G. duodenalis\G. lamblia)
    • Amebiasis and amebic liver abscess caused by E. histolytica

    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.

    Side Effects

    Adverse events associated with the use of Tindamax may include, but are not limited to, the following:

    • Metalic Taste
    • Nausea
    • Anorexia
    • Dyspepsia
    • Vomiting
    • Weakness
    • Diziness
    • Headache

    Dosing/Administration

    Tindamax is supplied as an oral tablet at one of two dosing strengths (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.

    Clinical Trial Results

    Approval of Tindamax for trichomoniasis was based on the combined results of 34 studies involving over 2,800 subjects. Four 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 percent (37/40) to 100 percent (65/65) (n=172 total subjects). Four blinded, randomized, comparative studies assessed efficacy by wet mount between seven to14 days post-treatment. Reported cure rates ranged from 80 percent (8/10) to 100 percent (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 four open-label trials in men (one comparative to metronidazole and three single arm studies). Parasitological evaluation of the urine was performed both pre- and post-treatment, and reported cure rates ranged from 83 percebt (25/30) to 100 percent (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 percent (40/50) to 100 percent (15/15). In three of these trials where the comparator was two to three days of various doses of metronidazole, reported cure rates for metronidazole were 76 percent (19/25) to 93 percent (14/15). Data comparing a single 2 g dose of tinidazole to the recommended  five to seven days of metronidazole are limited.

    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 three days. In four randomized, controlled studies (one investigator single-blind, three open-label) using this dose, reported cure rates after three days among 220 subjects ranged from 86 percent (25/29) to 93 percent (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 two to five days. In seven randomized, controlled studies (one  double-blind, one single-blind, five open-label) at that dose (with additional aspiration of the liver abscess when clinically necessary), reported cure rates among 133 subjects ranged from 81 percent (17/21) to 100 percent (16/16); four of these studies utilized at least three days of tinidazole.

    Additional Information

    For additional information regarding Tindamax or protozoal infections, please visit web page the Tindamax web page.

    Approval Date: 2004-05-01
    Company Name: Presutti Laboratories
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing