The Basics
What is Tinidazole?
Used to treat trichomoniasis, giardiasis, and amebiasis; also used to treat bacterial vaginosis.
Brand names for Tinidazole
Tindamax
How Tinidazole is classified
Antibacterial Agents, Antiprotozoal Agents, Nitroimidazoles, Antiprotozoal Agents, Nitroimidazoles, Nitroimidazoles
Tinidazole During Pregnancy
Tinidazole pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Tinidazole while pregnant
The use of tinidazole in pregnant patients has not been studied. Since tinidazole crosses the placental barrier and enters fetal circulation it should not be administered to pregnant patients in the first trimester. Embryo-fetal developmental toxicity studies in pregnant mice indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in rat neonates following maternal doses as high as 600 mg/kg (3- fold the highest human therapeutic dose based upon body surface area conversions). Although there is some evidence of mutagenic potential and animal reproduction studies are not always predictive of human response, the use of tinidazole after the first trimester of pregnancy requires that the potential benefits of the drug be weighed against the possible risks to both the mother and the fetus.
Taking Tinidazole While Breastfeeding
What are recommendations for lactation if you're taking Tinidazole?
Amounts of tinidazole in milk are less than doses given to infants. Measurements of infant plasma levels during breastfeeding have not been reported. No studies have evaluated adverse effects of tinidazole on the infant during breastfeeding, but presumably they are similar to those of the closely related drug, metronidazole, such as increased risk of oral and rectal Candida infections. As with metronidazole, concern has been raised about exposure of healthy infants to tinidazole via breastmilk,[1] because of possible mutagenicity and carcinogenicity. Opinions vary among experts on the advisability of using tinidazole during longer-term therapy while breastfeeding, but avoidance of breastfeeding for 3 days after a single dose should allow milk levels to drop to negligible values.[2] Other drugs are available for bacterial vaginosis, and can be given vaginally, which should result in lower amounts in breastmilk.
Maternal / infant drug levels
Amounts of tinidazole in milk are less than doses given to infants. Measurements of infant plasma levels during breastfeeding have not been reported. No studies have evaluated adverse effects of tinidazole on the infant during breastfeeding, but presumably they are similar to those of the closely related drug, metronidazole, such as increased risk of oral and rectal Candida infections. As with metronidazole, concern has been raised about exposure of healthy infants to tinidazole via breastmilk,[1] because of possible mutagenicity and carcinogenicity. Opinions vary among experts on the advisability of using tinidazole during longer-term therapy while breastfeeding, but avoidance of breastfeeding for 3 days after a single dose should allow milk levels to drop to negligible values.[2] Other drugs are available for bacterial vaginosis, and can be given vaginally, which should result in lower amounts in breastmilk.
Possible effects of Tinidazole on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Tinidazole
(Anaerobic bacterial infections) Amoxicillin and Clavulanic Acid, Clindamycin, Doxycycline; (Bacterial Vaginosis) Clindamycin, Metronidazole; (Giardiasis) Metronidazole.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. American Academy of Pediatrics Committee on Drugs. The transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-89. PMID: 11533352
2. Evaldson GR, Lindgren S, Nord CE et al. Tinidazole milk excretion and pharmacokinetics in lactating women. Br J Clin Pharmacol. 1985;19(4):503-7. PMID: 4039599
3. Wood BA, Faulkner JK, Monro AM. The pharmacokinetics, metabolism and tissue distribution of tinidazole. J Antimicrob Chemother. 1982;10 (Suppl A):43-57. PMID: 7118775
4. Mannisto PT, Karhunen M, Koskela O et al. Concentrations of tinidazole in breast milk. Acta Pharmacol Toxicol (Copenh). 1983;53(3):254-6. PMID: 6356785
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.