PROSTIN E2 VAGINAL TABLET 3 mg

4.1 Therapeutic Indications

Induction of labor in term or near-term pregnant women who have favorable induction features, and who have a singleton pregnancy with a vertex presentation.

4.3 Contraindications

Dinoprostone should not be used in patients with a hypersensitivity to dinoprostone or any of the other components of the product.

Dinoprostone should not be used in patients in whom oxytocic drugs are generally contraindicated such as:

• multiple gestation
• grand multiparity (6 or more previous term pregnancies)
• engagement of the head has not taken place
• previous uterine surgery (e.g., cesarean section, hysterotomy)
• cephalopelvic disproportion
• fetal heart rate pattern suggests incipient fetal compromise
• obstetric conditions where either maternal or fetal benefit/risk ratio favors surgical intervention
• unexplained vaginal discharge and/or abnormal uterine bleeding during current pregnancy
• nonvertex presentation

4.2 Posology and Method of Administration

The initial dose is 1 tablet (3 mg) of dinoprostone inserted high into the posterior fornix. A second tablet may be inserted after 6–8 hours if labor has not been established. The maximum or total dose in 24 hours is 6 mg.

Usage is restricted to qualified health care professionals and to hospitals and clinics with specialized obstetric units with facilities for continuous monitoring.

The recommended dose should not be exceeded, and the dosing interval should not be shortened as this increases the risk of uterine hyperstimulation, uterine rupture, uterine hemorrhage, fetal and neonatal death.