Proston Vaginal Gel

Proston Vaginal Gel is used for: Cervical ripening, induction and augmentation of labor

Endocervical gel For ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction. Adult: As cervical gel: Insert 0.5 mg into the cervical canal, may be repeated at 6 hr interval, if needed. Max: 1.5 mg/24 hr.

To prepare the product for use remove the protective end cap (to serve as plunger extension) and insert the protective end cap into the plunger stopper assembly in the barrel of syringe. Choose the appropriate length shielded catheter (10 mm or 20 mm) and aseptically remove the sterile shielded catheter from the package. Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. That is, the 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Firmly attach the catheter hub to the syringe tip as evidenced by a distinct click. Fill the catheter with sterile gel by pushing the plunger assembly to expel air from the catheter prior to administration to the patient. To properly administer the product, the patient should be in a dorsal position with the cervix visualized using a speculum. Using sterile technique, introduce the gel with the catheter provided into the cervical canal just below the level of the internal os. Administer the contents of the syringe by gentle expulsion and then remove the catheter. The gel is easily extrudable from the syringe. Use the contents of one syringe for one patient only. No attempt should be made to administer the small amount of gel remaining in the catheter. The syringe, catheter, and any unused package contents should be discarded after use. Following administration of Dinoprostone Gel, the patient should remain in the supine position for at least 15–30 minutes to minimize leakage from the cervical canal. If the desired response is obtained from Dinoprostone Gel, the recommended interval before giving intravenous oxytocin is 6–12 hours. If there is no cervical/uterine response to the initial dose of Dinoprostone Gel, repeat dosing may be given. The recommended repeat dose is 0.5 mg dinoprostone with a dosing interval of 6 hours. The need for additional dosing and the interval must be determined by the attending physician based on the course of clinical events. The maximum recommended cumulative dose for a 24-hour period is 1.5 mg of dinoprostone (7.5 mL Gel).

Hypersensitivity to the drug or components Patients for whom oxytocic drugs are contraindicated History of cesarean section or major uterine surgery Cephalopelvic disproportion present Cases of fetal distress where delivery not imminent History of difficult labor or traumatic delivery 6 or more previous term pregnancies (grand multiparae) Cases with hyperactive or hypertonic uterine patterns Unexplained vaginal bleeding during pregnancy Cases where vaginal delivery not indicated Cases with nonvertex presentation

FOR HOSPITAL USE ONLY Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be administered by physicians in a hospital that can provide immediate intensive care and acute surgical facilities. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction. Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase. The Clinician should be alert that the intracervical placement of dinoprostone gel may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). During use, uterine activity, fetal status, and character of the cervix (dilation and effacement) should be carefully monitored either by auscultation or electronic fetal monitoring to detect possible evidence of undesired responses, e.g., hypertonus, sustained uterine contractility, or fetal distress. In cases where there is a history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the fetus should be continuously monitored. The possibility of uterine rupture should be borne in mind when high-tone myometrial contractions are sustained. Caution should be exercised in administration of Dinoprostone Gel in patients with: asthma or history of asthma glaucoma or raised intraocular pressure Caution should be taken so as not to administer Dinoprostone Gel above the level of the internal os. Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. That is, the 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Placement of Dinoprostone Gel into the extraamniotic space has been associated with uterine hyperstimulation. As Dinoprostone Gel is extensively metabolized in the lung, liver, and kidney, and the major route of elimination is the kidney, Dinoprostone Gel should be used with caution in patients with renal and hepatic dysfunction. Patients with Ruptured Membranes Caution should be exercised in the administration of Dinoprostone Gel in patients with ruptured membranes. The safety of use of Dinoprostone Gel in these patients has not been determined. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic bioassay studies have not been conducted in animals with Dinoprostone Gel due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.

Pregnancy Indicated for initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for induction of labor Limited available data with use in pregnant women do not show a clear association with adverse developmental outcomes; relevant animal reproduction data with dinoprostone is not available When therapy was removed for fetal distress, there was a return to normal rhythm and there were no neonatal sequelae; remove therapy in the event of persistent tachysystole with or without fetal heart rate changes, and follow established institutional protocols in management of patients Lactation Concomitant administration of is not indicated in breastfeeding women; there is no information on effects of maternal administration on breastfed child Insufficient information is available on effects of maternal administration on milk production

Dinoprostone Gel may augment the activity of other oxytocic agents and their concomitant use is not recommended. For the sequential use of oxytocin following Dinoprostone Gel administration, a dosing interval of 6–12 hours is recommended.

Side effects of Dinoprostone vaginal prep : 1-10% Fever/temperature elevations (1%) GI upset (6%) Abnormal uterine contractions (7%) Warm feeling in vagina (2%) Back pain (3%) <1% Amnionitis Premature rupture of membranes Uterine rupture Postpartum disseminated intravascular coagulation

Dinoprostone Gel administered endocervically may stimulate the myometrium of the gravid uterus to contract in a manner similar to contractions seen in the term uterus during labor. Whether or not this action results from a direct effect of dinoprostone on the myometrium has not been determined. Dinoprostone is also capable of stimulating smooth muscle of the gastrointestinal tract in humans. This activity may be responsible for the vomiting and/or diarrhea that is occasionally seen when dinoprostone is used for preinduction cervical ripening. In laboratory animals, and also in humans, large doses of dinoprostone can lower blood pressure, probably as a result of its effect on smooth muscle of the vascular system. With the doses of dinoprostone used for cervical ripening this effect has not been seen. In laboratory animals, and also in humans, dinoprostone can elevate body temperature; however, with the dosing used for cervical ripening this effect has not been seen. In addition to an oxytocic effect, there is evidence suggesting that this agent has a local cervical effect in initiating softening, effacement, and dilation. These changes, referred to as cervical ripening, occur spontaneously as the normal pregnancy progresses toward term and allow evacuation of uterine contents by decreasing cervical resistance at the same time that myometrial activity increases. While not completely understood, biochemical changes within the cervix during natural cervical ripening are similar to those following PGE2-induced ripening. Further, it has been shown that these changes can take place independent of myometrial activity; however, it is quite likely that PGE2 administered endocervically produces effacement and softening by combined contraction-inducing and cervical-ripening properties. There is evidence to suggest that the changes that take place within the cervix are due to collagen degradation resulting from collagenase secretion as a response, at least in part, to PGE2. PGE2 is completely metabolized in humans. PGE2 is extensively metabolized in the lungs, and the resulting metabolites are further metabolized in the liver and kidney. The major route of elimination of the products of PGE2 metabolism is the kidneys.

Proston 0.5 mg/3 gm Vaginal Gel manufactured by Renata PLC.. Its generic name is Dinoprostone vaginal prep. Proston is availble in Bangladesh. Farmaco BD drug index information on Proston Vaginal Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.