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Secnidazole Pregnancy and Breastfeeding Warnings

Secnidazole is also known as: Solosec

Secnidazole Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity. In pregnant rats and rabbits administered oral doses during organogenesis at 100, 300, and 1000 mg/kg/day (up to 4 times the clinical dose based on AUC comparisons) and up to 100 mg/kg/day (about 0.1 times the clinical dose based on AUC comparisons), respectively, maternal toxicity (including reduced body weight gain at 300 mg/kg/day and higher in rats; reduced food intake and markedly reduced body weight gain at 100 mg/kg/day in rabbits) was seen; no evidence of adverse developmental outcomes was observed in rats or rabbits. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not assigned. Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Secnidazole Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 96 hours after the last dose. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Other nitroimidazole derivatives are excreted into human milk. -The effects in the nursing infant are unknown; potential for serious side effects (including tumorigenicity) -Nursing mothers may pump and discard their milk during and for 96 hours (based on half-life) after therapy and feed their infants stored human milk or formula.

See references

References for pregnancy information

  1. "Product Information. Solosec (secnidazole)." Symbiomix Therapeutics , Newark, NJ.

References for breastfeeding information

  1. "Product Information. Solosec (secnidazole)." Symbiomix Therapeutics , Newark, NJ.

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