STD Quarterly: Trichomoniasis drug given FDA approval

Clinicians now have a second option in treating trichomoniasis, which accounts for nearly one-third of the 15.4 million cases of sexually transmitted diseases (STDs) in the United States.1 The Food and Drug Administration (FDA) has approved Tindamax (tinidazole) for the treatment of trichomoniasis, giardiasis, intestinal amebiasis, and amebic liver abscess.

Recent data have found trichomoniasis to be far more prevalent today than chlamydia or gonorrhea, says John Presutti, president of Presutti Laboratories of Arlington Heights, IL, the drug’s manufacturer. A recently published analysis shows that trichomoniasis, human papillomavirus, and chlamydia, accounted for 88% of all new cases of STDs among young Americans ages 15-24.2

Presutti Laboratories plans to begin marketing 500 mg and 250 mg tablets of Tindamax early in the third quarter of 2004. The drug, approved in May 2004, was scheduled to reach pharmacy shelves in July, reports Barbara Palombo, company spokeswoman. Estimated wholesale price is $18 for a 2 g course of therapy, she states. For trichomoniasis, the treatment regimen is a one-time 2 g dose; it is recommended that the drug be taken with food to further minimize gastrointestinal upset. (See the resource box below for company contact information.)

Option for drug resistant cases

Tinidazole, a second-generation 5-nitroimidazole compound, joins metronidazole (Flagyl, GD Searle, Chicago; metronidazole, Watson Pharmaceuticals, Corona, CA) as a treatment option for trichomoniasis. While metronidazole remains an effective treatment for most persons infected with T. vaginalis, the existence of drug-resistant infections is becoming increasingly recognized.

Tinidazole may provide an option for such cases. Both drugs are effective: in a meta-analysis of nitroimidazoles where the majority of studies used tinidazole or metronidazole to treat trichomoniasis, parasitological cure was achieved in 90% of cases.3

Reported adverse effects during clinical trials with tinidazole generally have been self-limiting, according to Presutti Labs. According to the package insert, among 3,669 patients treated with a single 2-g dose for trichomoniasis or giardiasis, adverse effects were reported by 11% of patients. These include gastrointestinal effects such as metallic taste and nausea, and weakness/fatigue.

Check for symptoms

What should clinicians check for when it comes to trichomoniasis? In women, symptoms can include a yellow, gray, or green frothy vaginal discharge, often accompanied by malodor. Burning, itching, soreness, and redness of the vulva or vagina often are present. Urination and intercourse may be painful, and signs and symptoms may worsen during menstruation.

Trichomoniasis infection is frequently asymptomatic in men. When symptoms are present, they may consist of urethral discharge and irritation.

Wet mount preparation has been the most commonly used method for diagnosis of trichomoniasis. In women, vaginal secretions may be obtained from the lateral walls and fornices using a swab or plastic loop In men, urethral discharge, prostate secretions, or urethral scrapings may be tested.4

References

1. Cates W, Jr. Estimates of the incidence and prevalence of sexually transmitted diseases in the United States. Sex Transm Dis 1999; 26(suppl):S2-S7.

2. Weinstock H, Berman S, Cates Jr. W. Sexually transmitted diseases among American youth: Incidence and prevalence estimates, 2000. Perspect Sex Reprod Health 2004; 36:6-10.

3. Gulmezoglu AM, Garner P. Trichomoniasis treatment in women: A systematic review. Trop Med Int Health 1998; 3:553-558.

4. Swygard H, Sena AC, Hobbs MM, et al. Trichomoniasis: clinical manifestations, diagnosis, and management. Sex Transm Infect 2004; 80:91-95.

Resource

For more information on tinidazole, contact:

  • Presutti Laboratories, 1607 N. Douglas Ave., Arlington Heights, IL 60004. Telephone: (888) 405-7800 or (847)359-7800. Web: www.presuttilabs.com.