[Study on cefotiam in the perinatal period].

Area of Science:

• Pharmacology
• Microbiology
• Obstetrics

Context:

• Investigating the efficacy and safety of Cefotiam (CTM), a novel cephem antibiotic.
• Focusing on its application in mothers during the perinatal period.

Purpose:

• To evaluate the pharmacokinetic profile of CTM in maternal serum, umbilical cord serum, and amniotic fluid.
• To assess the safety and tolerability of CTM in neonates born to mothers receiving the antibiotic.
• To determine an appropriate and safe dosage regimen for CTM in perinatal infections.

Summary:

• Cefotiam (CTM) demonstrated high activity against Gram-positive and Gram-negative bacteria.
• Following a 1g intravenous dose, maternal serum CTM concentration reached 38 µg/ml at 0.5 hours.
• Significant CTM transfer was observed into umbilical cord serum and amniotic fluid.
• No adverse effects were noted in neonates, indicating a favorable safety profile.
• A daily maternal dosage of 1-2 g is considered safe and effective for treating perinatal infections.

Impact:

• Establishes Cefotiam (CTM) as a potentially valuable antibiotic for managing perinatal infections.
• Provides crucial data on CTM's pharmacokinetic behavior and safety in the perinatal setting.
• Informs clinical practice regarding the use of CTM in pregnant and breastfeeding mothers.
• Supports the development of evidence-based treatment guidelines for infections during pregnancy.