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Tinidazole Pregnancy and Breastfeeding Warnings

Tinidazole is also known as: Fasigyn, Tindamax

Tinidazole Pregnancy Warnings

Use is contraindicated during the first trimester of pregnancy; this drug should be used during the second and third trimesters of pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have revealed evidence of a slightly higher incidence of fetal mortality and some evidence of mutagenic potential. This drug crosses the placenta and enters fetal circulation. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Tinidazole Breastfeeding Warnings

This drug has been detected in breast milk in levels similar to those seen in serum; it has been detected in breast milk for more than 72 hours after use. Amounts of this drug in milk are less than doses given to infants; infant plasma levels have not been measured during breastfeeding. Expert opinions vary regarding use during longer-term therapy while breastfeeding; however, avoiding nursing for 3 days after a single dose should allow milk levels to decline to negligible values. On day 4 postpartum, 3 women started twice-daily oral dosing. On day 7, milk samples were collected 2, 5, and 9 hours after dosing; breast milk levels ranged between 5.8 and 12.7 mg/L. After cord clamping, 24 women who delivered by cesarean section were given a single 500 mg IV dose. Colostrum drug levels averaged 5.8 mg/L at 12 hours after the dose, 3.5 mg/L at 24 hours, 1.2 mg/L at 48 hours, and 0.3 mg/L at 72 hours after the dose; the drug was barely detectable 96 hours after the dose. There were only slight differences between levels in foremilk and hindmilk. After cord clamping, 5 women who delivered by cesarean section were given a single 1600 mg IV dose. Milk levels and volumes were measured for 96 hours after the dose. The authors concluded that milk levels would be low enough to start breastfeeding 72 hours after the dose.

Breastfeeding is not recommended during use of this drug and for 72 hours after the last dose; other drugs are available for some conditions. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown; however, they are likely similar to those of metronidazole (closely related), such as increased risk of oral and rectal Candida infections.

See references

References for pregnancy information

  1. "Product Information. Tindamax (tinidazole)." Presutti Laboratories Inc, Arlington Heights, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Tindamax (tinidazole)." Presutti Laboratories Inc, Arlington Heights, IL.

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