Tinidazole is used orally in the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and children older than 3 years of age. Tinidazole is designated an orphan drug by the US Food and Drug Administration (FDA) for treatment of amebiasis.
The regimen of choice for symptomatic intestinal amebiasis or extraintestinal disease (including liver abscess) is treatment with a nitroimidazole derivative (oral tinidazole or oral metronidazole) followed by treatment with a luminal amebicide (oral iodoquinol or oral paromomycin). The sequential use of these drugs ensures eradication of tissue-invading trophozoites as well as cysts in the intestinal lumen. In patients with severe disease who do not respond to or cannot tolerate these drugs, some clinicians suggest that a regimen of dehydroemetine (available in the US only from the US Centers for Disease Control and Prevention [CDC]) followed by a luminal amebicide can be considered. For further information on treatment of amebiasis,
Tinidazole and metronidazole are not recommended for treatment of asymptomatic cyst passers; these patients should be treated with a luminal amebicide such as iodoquinol, paromomycin, or diloxanide furoate (not commercially available in the US). For information on treatment of asymptomatic amebiasis, .
Use of oral tinidazole (usually 2 g daily for 3 days) in patients with intestinal amebiasis is supported by published reports involving more than 1400 patients worldwide. Results of 4 randomized, controlled studies (one single-blind and 3 open-label) in 220 patients have shown that intestinal amebiasis cure rates of 86-93% were achieved with the currently recommended tinidazole regimen (2 g daily for 3 days). A similar cure rate was reported in a clinical series of 40 pediatric patients with intestinal amebiasis treated with the currently recommended pediatric regimen of 50 mg/kg of tinidazole daily for 3 days.
Use of oral tinidazole (usually 2 g daily for 2-5 days) in patients with liver abscess is supported by published reports involving more than 470 patients worldwide. Results of 7 randomized, controlled studies (one double-blind, 1 single-blind, and 5 open-label) in 133 patients have shown that liver abscess cure rates of 81-100% were achieved with tinidazole (2 g daily for 2-5 days) accompanied by aspiration of the liver abscess (when clinically necessary).
Tinidazole is used orally in the treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis) in adults and children older than 3 years of age. Tinidazole is designated an orphan drug by the FDA for use in this condition.
Drugs of choice for the treatment of giardiasis are metronidazole, tinidazole, or nitazoxanide; alternative agents include paromomycin (especially in pregnant women), furazolidone (no longer commercially available in the US), or quinacrine (not commercially available in the US). Although tinidazole appears to be as effective or more effective than metronidazole for the treatment of giardiasis and may be better tolerated, limited safety and efficacy information is available in pediatric patients less than 3 years of age. For further information on treatment of giardiasis,
Use of oral tinidazole (2-g single dose) in patients with giardiasis is supported by published reports involving more than 1600 adult and pediatric patients worldwide. Results of 8 controlled studies in 619 patients have shown that giardiasis cure rates of about 80-100% were achieved (299 patients received the currently recommended tinidazole regimen, a single 2-g dose in adults and a single 50-mg/kg [up to 2-g] dose in children). In 3 of these studies in which metronidazole was compared with tinidazole, comparative giardiasis cure rates of about 76-93% were achieved with various dosage regimens of metronidazole given for 2-3 days. However, data comparing tinidazole (2-g single dose) with metronidazole (given in the usually recommended dosage of 250 mg 3 times daily for 5-7 days) are limited.
Tinidazole is used orally in the treatment of symptomatic and asymptomatic trichomoniasis in adults in whom Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).
The nitroimidazole derivatives, tinidazole and metronidazole, are the only drugs currently commercially available in the US that are effective in the treatment of this disease. Although in some limited studies a single dose of tinidazole was associated with a higher cure rate than a single dose of metronidazole, the relative efficacy of tinidazole and metronidazole in the treatment of trichomoniasis has not been adequately studied to date in large, well-controlled studies. Tinidazole reportedly has been effective for the treatment of trichomoniasis in some patients who did not respond to metronidazole, but there is evidence from in vitro studies that some T. vaginalis isolates with reduced susceptibility to metronidazole may also have reduced susceptibility to tinidazole.
The goal of treatment is to provide symptomatic relief, achieve microbiologic cure, reduce transmission, and prevent reinfection; to achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated simultaneously. Because trichomoniasis is a sexually transmitted disease with a potential for serious sequelae, the CDC and other experts recommend that infected individuals and their sexual contacts be treated regardless of symptomatology; therefore, asymptomatic sexual contacts should be treated presumptively even when T. vaginalis has not been demonstrated. For further information on treatment of trichomoniasis,
Use of oral tinidazole (single 2-g dose) in patients with trichomoniasis is supported by published reports involving more than 2800 patients worldwide. Results of 4 published, blinded, randomized comparative studies in 172 patients have shown that trichomoniasis cure rates of about 92-100% were achieved with the currently recommended tinidazole regimen (single 2-g dose). Test-of-cure in these studies was assessed by culture at time points within 1 week to 1 month post-treatment. In 4 other published, blinded, randomized comparative studies in 116 patients, in which test-of-cure was assessed by wet mount within 7-14 days post-treatment, trichomoniasis cure rates ranged from 80-100%. In these studies, efficacy of tinidazole was superior to placebo and comparable to metronidazole. When efficacy of a single 2-g dose of tinidazole was assessed in 4 open-label trials in 142 men (1 comparative study with metronidazole and 3 single-arm studies), parasitologic evaluation of the urine (pre- and post-treatment) indicated trichomoniasis cure rates of 83-100%.
Tinidazole is used orally for the treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in nonpregnant women. Other pathogens commonly associated with vulvovaginitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses) should be ruled out.
The principal goal in the treatment of bacterial vaginosis in nonpregnant women is to provide relief of vaginal symptoms and signs of infection and to reduce the risk for infectious complications after hysterectomy or abortion. Other potential benefits include a reduction in other infectious complications, including human immunodeficiency virus (HIV) infection and other sexually transmitted diseases (STDs). The CDC states that treatment of bacterial vaginosis is indicated in all nonpregnant women who are symptomatic. The CDC-recommended regimens for treatment of bacterial vaginosis in nonpregnant women are a 7-day regimen of oral metronidazole (500 mg twice daily); a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream. Alternative regimens recommended by the CDC for these women are a 7-day regimen of oral clindamycin or a 3-day regimen of intravaginal clindamycin suppositories. Routine treatment of sex partners is not recommended. CDC recommendations were issued in 2006; use of tinidazole for bacterial vaginosis was approved by the US Food and Drug Administration (FDA) in 2007.
Results of clinical studies indicate that tinidazole is effective for the treatment of bacterial vaginosis. In one study, nonpregnant women with bacterial vaginosis were randomized to receive tinidazole 1 g daily for 5 days, tinidazole 2 g daily for 2 days, or placebo. Therapeutic cure (clinical cure and microbiologic cure) was reported in 36.8, 27.4, or 5.1% of those receiving tinidazole 1 g daily for 5 days, tinidazole 2 g daily for 2 days, or placebo, respectively, 21-30 days following completion of therapy.
Tinidazole is used orally for the treatment of recurrent and persistent urethritis in patients with nongonococcal urethritis who have already been treated with a recommended regimen.
The CDC currently recommends that nongonococcal urethritis in adults be treated with a single oral dose of azithromycin or a 7-day regimen of oral doxycycline; alternative regimens recommended by the CDC are a 7-day regimen of oral erythromycin base or ethylsuccinate or a 7-day regimen of oral ofloxacin or oral levofloxacin. Patients treated for nongonococcal urethritis should be instructed to abstain from sexual intercourse until 7 days after initiation of treatment and to return for evaluation if symptoms persist or recur after completion of therapy; symptoms alone (without documentation of signs or laboratory evidence of urethral inflammation) are not sufficient basis for retreatment. Patients with persistent or recurrent urethritis who were not compliant with the treatment regimen or were reexposed to an untreated sexual partner(s) should be retreated with the initial regimen. If the patient has recurrent and persistent urethritis, was compliant with the regimen, and reexposure can be excluded, the CDC recommends a single 2-g dose of oral metronidazole or oral tinidazole given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin was not used in the initial regimen).