Misodel (misoprostol vaginal insert / formulation)

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Misodel (misoprostol 200 mcg) is an advanced controlled-release vaginal delivery system used specifically for the induction of labor in women with an “unfavorable” cervix at or near term (36 weeks gestation or later). Unlike traditional vaginal tablets like Vagiprost that dissolve quickly, Misodel is a removable polymer insert (pessary) with a retrieval tail. It is designed to swell upon contact with vaginal moisture, releasing a steady, low dose of misoprostol (approximately 7 mcg per hour) for up to 24 hours. This ensures a more predictable and sustained process of cervical ripening and labor initiation

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Introduction

MISODEL (Misoprostol) has been approved for induction of labour in women with an unfavourable cervix, from 36 weeks of gestation, in whom induction is clinically indicated. An unfavourable cervix is a cervix that has not yet softened and thinned so that dilation can take place.

The study compared the 200 mcg MISODEL^TM controlled release vaginal delivery system with the 10-mg dinoprostone vaginal insert (DVI), in terms of efficacy and safety. The EXPEDITE study showed that MISODEL^TM significantly reduced the time to vaginal delivery compared to DVI.

Precautions:

If of childbearing age, a negative pregnancy test is required before starting treatment, and effective birth control must be used during treatment and for at least one month after stopping.