BfArM Issues Reminder on Proper Use of Misoprostol

The Federal Institute for Drugs and Medical Devices (BfArM) has issued an important reminder regarding the correct administration of Angusta®, a medication containing Misoprostol. This medication is indicated for the oral induction of labor and must only be administered by qualified healthcare professionals within a hospital setting. Continuous monitoring of both the fetus and the uterus is required during its use.

Each tablet of Angusta® contains 25 micrograms of Misoprostol, and its use is only recommended from the 37th week of pregnancy due to a lack of clinical data supporting earlier administration. Before initiating treatment, healthcare providers must conduct a thorough assessment of the cervix.

BfArM emphasizes the necessity of adhering to the specified dosage instructions, intervals between doses, and recognizing specific contraindications. Notably, the drug should not be administered once labor has commenced or if regular, painful contractions are already evident.

The recommended dosing regimen includes administering 25 micrograms orally every two hours or 50 micrograms every four hours, in line with standard hospital practices. The maximum allowable daily dose is capped at 200 micrograms. During and after administration, continuous monitoring of both the fetus and the uterus is critical.

Healthcare professionals and patients should be aware of serious potential side effects associated with Misoprostol, which may include uterine hyperstimulation, with or without alterations in fetal heart rate, placental abruption, uterine rupture, and neonatal asphyxia. It is essential that women are thoroughly informed about the significant risks linked to uterine hyperstimulation and the necessity to discontinue administration if contractions begin.