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:Prostaglandin E2

Function and indication:
Used to promote cervical ripening during full-term pregnancy (starting from the 38th week of pregnancy), with a Bishop score of less than or equal to 6 points, single fetus with cephalic presentation, indication for induction of labor and no maternal and fetal contraindications. Bishop should use the method listed in (1964) Obstetrics and Gynecology, 242, pp. 266-268.
Usage and Dosage:
The dosage and usage of this product may vary for different dosage forms and specifications. Please read the specific drug instructions for use or follow the doctor’s advice. Dinoprostone suppository: 1. After taking this product out of the freezer, insert it directly into the vagina. 2. Placement method: Do not remove the suppository from the self-recovery device. Place the suppository in the posterior fornix. A small amount of water-soluble lubricant can be used to assist placement. To ensure that the suppository is properly positioned, rotate it 90 degrees. Place it horizontally in the fornix. Leave a certain length (2-3cm) of tape outside the vagina for easy removal. After placement, ensure that the patient rests in bed for 20 to 30 minutes. Since prostaglandin E2 will be released continuously within 24 hours, uterine contractions and fetal conditions should be monitored regularly. 3. Removal: Gently pull the termination band, and the suppository can be removed quickly and easily. If the cervix is ​​not fully ripened within 24 hours, this product should also be removed. For the use of oxytocin after the removal of this product, the recommended dosing interval is at least 30 minutes. 4. Dosage: Using one suppository is usually sufficient to achieve cervical ripening. 5. The suppository should be removed and the dosing should be terminated when the cervix is ​​fully ripe or the following conditions occur: Labor is based on the purpose of using this product to induce labor. Labor is defined as regular painful contractions every 3 minutes, regardless of cervical changes. After use, once there is regular uterine contraction, as long as it remains in place, dinoprostone will continue to be released, and the frequency and degree of contractions will not decrease. For parturients, especially multiparous women, sometimes regular uterine contractions occur, and there may be no obvious changes in the cervix. Only when contractions persist will the cervix disappear and expand. Therefore, if regular uterine contractions are already occurring, it is recommended that the product be removed regardless of the cervical status in order to avoid the risk of uterine hyperstimulation caused by leaving Simpson in place. Spontaneous or artificial rupture of membranes. Any signs of uterine hyperstimulation or uterine tonic contractions. Evidence of fetal distress. Maternal symptoms of systemic adverse reactions to dinoprostone, such as nausea, vomiting, hypotension and tachycardia. At least 30 minutes before starting intravenous infusion of oxytocin.
Adverse reactions:
Changes in fetal heart rate monitoring (CTG) and nonspecific fetal distress have been reported during or after vaginal administration of dinoprostone, increased likelihood of uterine contractions and uterine hypertonicity with or without fetal distress. If dinoprostone is not removed before oxytocin is administered, the risk of uterine hyperstimulation will be increased, as prostaglandins are known to have the potential to increase the effect of oxytocin on uterine tone. In a double-blind, randomized, placebo-controlled multicenter clinical study, after the subject’s Bishop score, a suppository was placed in the posterior vaginal fornix close to the cervix and placed for 12 hours. The suppository should be removed immediately when the mother’s labor begins or other adverse reactions occur. 206 pregnant women participated in the trial, of which 102 received Xinpubeisan and 104 received placebo. Among the 102 patients, 5 (4.9%) experienced uterine hyperstimulation. Among these patients, 3 (2.9%) experienced adverse reactions related to fetal distress. Among the 5 patients who experienced uterine hyperstimulation, 4 of them had uterine hyperstimulation relieved after the drug was removed. All pregnant women who experienced adverse drug reactions delivered normal newborns vaginally. In post-marketing experience reports, uterine ruptures related to the use of this product have been rarely reported (see Contraindications and Precautions). It has been reported that pregnant women who went into labor after induction of labor with dinoprostone or oxytocin have an increased risk of postpartum disseminated intravascular coagulation. It is known that dinoprostone can cause patent ductus arteriosus in the fetus during pregnancy, but there are no reports of cyanosis in the neonatal period after the use of simpusin. In a 3-year follow-up of 121 infants who had used dinoprostone for induced labor (51 of whom used this product), no adverse reactions to the physical development and psychomotor growth of the infants were found. Regarding reports of adverse reactions in China: The results of a multicenter, prospective, case-control study showed that 100 parturients used 1.1mm simpusin and 49 parturients used vaginal suppositories with the same appearance and without drugs. 12 hours after medication, 93% of the parturients in the simpusin group had a Bishop score increase of ≥2 points, and 87% had a score increase of ≥3 points, while only 4% of the parturients in the control group had a Bishop score increase of ≥2 points. After using simpusin, the time from medication to labor, rupture of membranes, and delivery was significantly shortened. There was no significant difference in fetal heart rate changes and the incidence of abnormal amniotic fluid during labor between the two groups of parturients using simpusin and placebo; there was no significant difference in the birth status of the newborns in the two groups. Uterine overstimulation is the main side effect of Probeson, but the incidence in the study group was only 3%, which improved after removal, and 2% of cases had mild gastrointestinal reactions.
This product should not be used or left in place in the following situations: 1. Labor is imminent. 2. Oxytocin is being given. 3. In situations where the patient should not have excessive and prolonged contractions, such as a history of major uterine surgery, such as cesarean section, myomectomy, etc.

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