![]() Dinoprostone stimulates the production of prostaglandin F 2α (PGF 2α), which sensitizes the myometrium to endogenous or exogenously administered oxytocin. In pregnancy, dinoprostone is secreted continuously by the fetal membranes and placenta and plays an important role in the final events leading to the initiation of labor including cervical ripening. The chemical name for dinoprostone (known as prostaglandin E 2 or PGE 2) is 11α,15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below:ĭinoprostone is found in low concentrations in most tissues of the body and functions as a local hormone. The finished product is a controlled-release formulation that has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg per hour. The knitted polyester retrieval system has a long tape-like end that is designed to aid retrieval of CERVIDIL at the end of the dosing interval or earlier if clinically indicated. When placed in a moist environment, the yarn absorbs water, swells, and releases the enclosed dinoprostone. ![]() The vaginal insert is contained within a pouch of an off-white knitted polyester yarn retrieval system. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer (hydrogel polymer) that is semi-opaque, beige colored, flat, rectangular in shape with rounded corners and measuring 29 mm by 9.5 mm by 0.8 mm. Tocolytics were required in one of the five cases.ĬERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. In Trial 3 (with the retrieval system) cases of tachysystole uterine hyperstimulation reversed within 2 to 13 minutes of removal of CERVIDIL. Uterine tachysystole -without fetal distressįetal distress without uterine tachysystoleĭrug related fever, nausea, vomiting, diarrhea, and abdominal pain occurred in less than 1% of CERVIDIL-treated patients. Uterine tachysystole without fetal distressįetal distress without uterine tachysystole. Common Adverse Reactions (≥ 2%) in Pregnant Patients Near Term Gestation in Trial 1 *, Trial 2 *, and Trial 3 † * Trial 1 (101-103) and Trial 2 (101-003) evaluated the dinoprostone insert only, without the use of a retrieval system † Trial 3 (101-801) evaluated the dinoprostone insert with the retrieval system. Remove CERVIDIL prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone. Remove CERVIDIL at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity. Prostaglandins, including CERVIDIL, may potentiate the effect of oxytocin. CERVIDIL is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of the risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and the occurrence of fetal or neonatal death). Remove CERVIDIL with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences. While using CERVIDIL, carefully monitor uterine activity, fetal status and the progression of cervical dilatation and effacement. The use of CERVIDIL may cause uterine tachysystole with or without fetal heart rate changes (see Table 1). ![]() ![]() 5.4 Uterine Tachysystole and Uterine Hypersystole/Hypertonicity ![]()
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