Secnidazole

The Basics

What is Secnidazole?

Approved for the treatment of bacterial vaginosis.

Brand names for Secnidazole

Solosec

How Secnidazole is classified

Anti-Infective Agents, Antiprotozoal Agents, Nitroimidazoles

Secnidazole During Pregnancy

Secnidazole pregnancy category

Category Not AssignedNote 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 Secnidazole while pregnant

Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, pregnant rats were dosed orally with secnidazole during organogenesis (gestational days 6-17) at 100, 300 and 1000 mg/kg/day, up to 4 times the clinical dose based on AUC comparisons. Animals showed no evidence of adverse developmental outcomes, but maternal toxicity (including reduced body weight gain) was observed at and above 300 mg/kg/day. In rabbits, no evidence of adverse developmental outcomes was observed when oral doses of secnidazole were administered to dams during organogenesis (gestational days 7-20) at doses up to 100 mg/kg/day (about 0.1 times the clinical dose, based on AUC comparisons). Secnidazole was associated with maternal toxicity (reduced food consumption and markedly reduced body weight gain) in dams at 100 mg/kg/day. In a peri-and post-natal development study in rats, secnidazole was administered at 30, 100 and 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation. Secnidazole was not associated with any adverse effects on gestation, parturition, lactation or on subsequent development of first generation (F1) and second generation (F2) offspring at these doses, equivalent to up to 1.4 times the clinical dose based on AUC comparisons. Maternal toxicity (reduced gestational body weight gain) was evident at doses of 100 mg/kg and above (about 0.3 times the clinical dose based on AUC comparisons).

Taking Secnidazole While Breastfeeding

What are recommendations for lactation if you're taking Secnidazole?

No information is available on the clinical use of secnidazole during breastfeeding and no studies have evaluated adverse effects of secnidazole 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 secnidazole via breastmilk, because of possible mutagenicity and carcinogenicity. Based on the secnidazole’s elimination half-life of approximately 17 hours, the manufacturer recommends avoidance of breastfeeding for 96 after a single dose. Other drugs are available for bacterial vaginosis, and can be given vaginally, which should result in lower amounts in breastmilk.

Maternal / infant drug levels

No information is available on the clinical use of secnidazole during breastfeeding and no studies have evaluated adverse effects of secnidazole 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 secnidazole via breastmilk, because of possible mutagenicity and carcinogenicity. Based on the secnidazole’s elimination half-life of approximately 17 hours, the manufacturer recommends avoidance of breastfeeding for 96 after a single dose. Other drugs are available for bacterial vaginosis, and can be given vaginally, which should result in lower amounts in breastmilk.

Possible effects of Secnidazole on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Secnidazole

(Bacterial Vaginosis) Clindamycin, Metronidazole.