From the Guidelines
Tinidazole is recommended for the treatment of giardiasis in pediatric patients aged ≥3 years, with a single dose of 50 mg/kg (maximum 2 g) taken with food. According to the 2017 Infectious Diseases Society of America clinical practice guidelines for the diagnosis and management of infectious diarrhea 1, tinidazole is approved in the United States for children aged ≥3 years and is available in tablets that can be crushed. The guidelines also note that metronidazole has a high frequency of gastrointestinal side effects and is not FDA approved for the treatment of giardiasis.
Key Considerations
- Tinidazole is not recommended for children under 3 years of age due to limited safety data 1.
- The medication should be administered with food to minimize gastrointestinal side effects, which may include nausea, vomiting, metallic taste, and abdominal discomfort.
- Parents should be advised that tinidazole may cause urine to darken and that alcohol should be avoided during treatment and for 3 days afterward due to potential disulfiram-like reactions.
Treatment Options
- For giardiasis, tinidazole is the recommended treatment, with a single dose of 50 mg/kg (maximum 2 g) taken with food 1.
- For amebiasis and anaerobic bacterial infections, the dosage and treatment duration may vary, but tinidazole is a viable option.
- Metronidazole is an alternative treatment option, but it has a higher frequency of gastrointestinal side effects and is not FDA approved for the treatment of giardiasis 1.
From the FDA Drug Label
- 4 Pediatric Use Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established Pediatric Administration: For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see Dosage and Administration ( 2.2)].
Tinidazole use in pediatrics is only established for the treatment of giardiasis and amebiasis in patients older than three years of age. For patients who cannot swallow tablets, tinidazole can be administered by crushing the tablets in artificial cherry syrup and taking with food. Safety and effectiveness in pediatric patients have not been established for other uses or in children under three years of age 2.
From the Research
Efficacy of Tinidazole in Pediatrics
- Tinidazole has been shown to be effective in treating giardiasis in children, with a higher parasitological cure rate compared to metronidazole 3, 4.
- A study comparing single-dose tinidazole and metronidazole in children with symptomatic giardiasis found that tinidazole had a significantly higher cure rate (80% vs 36%) 3.
- A network meta-analysis of randomized controlled trials found that tinidazole was associated with higher parasitological cure rates than metronidazole and albendazole 4.
- Tinidazole has also been shown to be effective in treating other protozoal infections, including trichomoniasis and amebiasis, with clinical cure rates generally >90% 5.
Comparison with Other Treatments
- Tinidazole has been compared to albendazole in the treatment of Giardia infections in children, with tinidazole showing significantly higher efficacy 6.
- A meta-analysis of five randomized controlled trials found that tinidazole outperformed albendazole in the treatment of Giardia infections in children, with a relative risk of 1.61 (95% CI: 1.40-1.85) 6.
- Tinidazole has also been compared to metronidazole, with tinidazole showing higher efficacy and fewer side effects 3, 4.
Safety and Tolerability
- Tinidazole has been shown to be generally well-tolerated in children, with common adverse effects including bitter taste, nausea, and abdominal discomfort 5.
- A study comparing single-dose tinidazole and metronidazole in children found that both drugs were well-tolerated, with no significant differences in adverse effects 3.